Background
Thalassaemia is a quantitative abnormality of haemoglobin caused by mutations in genes controlling production of alpha or beta globins. Abnormally unpaired globin chains cause haemolytic ...anaemia by causing membrane damage and cell death within organ systems and destruction of erythroid precursors in the bone marrow. The life‐long management of the general health effects of thalassaemia in affected individuals is a highly challenging issue in and of itself; and failure to deal with dental and orthodontic complications in people with thalassaemia exacerbates the public health, financial and personal burden posed by the condition. There exists a lack of evidence‐based guidelines for care‐seekers and providers to best deal with such dental and orthodontic complications in thalassaemia, which this review seeks to address.
Objectives
The main objective of this review was to assess different methods to treat dental and orthodontic complications in people with thalassaemia.
Search methods
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference books. We searched the reference lists of relevant articles and reviews.
Date of last search: 01 August 2019.
We also searched nine online databases (PubMed, Google Scholar, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, Literature in the Health Sciences in Latin America and the Caribbean database, African Index Medicus, Index Medicus for South East Asia Region, Index Medicus for the Eastern Mediterranean Region, Indexing of Indian Medical Journals). We searched the reference lists of relevant articles and reviews and contacted haematologists, experts in fields of dentistry, organizations, pharmaceutical companies and researchers working in this field.
Date of last search: 22 July 2019.
Selection criteria
We searched for published or unpublished randomised controlled trials for treatment of dental and orthodontic complications in individuals diagnosed with thalassaemia, irrespective of phenotype, severity, age, gender and ethnic origin.
Data collection and analysis
Two review authors independently screened 35,202 titles from search results. We identified four unique randomised controlled trials, of which one seemed potentially relevant. Based on closer inspection, the trial was found not to be eligible for inclusion.
Main results
We did not find any relevant trials for inclusion in the review.
Authors' conclusions
We were unable to draw any conclusions due to the lack of available data and trials. This review highlights the need for conducting and appropriate reporting, of high‐quality randomised controlled trials investigating the effectiveness of various treatment modalities for dental and orthodontic complications in people with thalassaemia.
Background
Bleeding disorders are uncommon but may pose significant bleeding complications during pregnancy, labour and following delivery for both the woman and the foetus. While many bleeding ...disorders in women tend to improve in pregnancy, thus decreasing the haemorrhagic risk to the mother at the time of delivery, some do not correct or return quite quickly to their pre‐pregnancy levels in the postpartum period. Therefore, specific measures to prevent maternal bleeding and foetal complications during childbirth, are required. The safest method of delivery to reduce morbidity and mortality in these women is controversial. This is an update of a previously published review.
Objectives
To assess the optimal mode of delivery in women with, or carriers of, bleeding disorders.
Search methods
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Coagulopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference books. We also searched the Cochrane Pregnancy and Childbirth Group's Trials Register as well as trials registries and the reference lists of relevant articles and reviews.
Date of last search of the Group's Trials Registers: 16 February 2017.
Selection criteria
Randomised controlled trials and all types of controlled clinical trials investigating the optimal mode of delivery in women with, or carriers of, any type of bleeding disorder during pregnancy were eligible for the review.
Data collection and analysis
No trials matching the selection criteria were eligible for inclusion
Main results
No results from randomised controlled trials were found.
Authors' conclusions
The review did not identify any randomised controlled trials investigating the safest mode of delivery and associated maternal and foetal complications during delivery in women with, or carriers of, a bleeding disorder. In the absence of high quality evidence, clinicians need to use their clinical judgement and lower level evidence (e.g. from observational trials, case studies) to decide upon the optimal mode of delivery to ensure the safety of both mother and foetus.
Given the ethical considerations, the rarity of the disorders and the low incidence of both maternal and foetal complications, future randomised controlled trials to find the optimal mode of delivery in this population are unlikely to be carried out. Other high quality controlled studies (such as risk allocation designs, sequential design, and parallel cohort design) are needed to investigate the risks and benefits of natural vaginal and caesarean section in this population or extrapolation from other clinical conditions that incur a haemorrhagic risk to the baby, such as platelet alloimmunisation.
Congenital bleeding disorders can cause obstetric haemorrhage during pregnancy, labour and following delivery. Desmopressin acetate is found to be an effective drug which can reduce the risk of ...haemorrhage and can also stop bleeding in certain congenital bleeding disorders. Its use in pregnancy has been controversial. Hence beneficial and adverse effects of desmopressin acetate in these groups of pregnant women should be evaluated.This is an update of a Cochrane review first published in 2013.
To determine the efficacy of desmopressin acetate in preventing and treating acute bleeds during pregnancy in women with congenital bleeding disorders.
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coaguopathies Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant and abstract books of conferences proceedings. We also searched for any randomised controlled trials in a registry of ongoing trials and the reference lists of relevant articles and reviews.Date of most recent search: 18 June 2015.
Randomised and quasi-randomised controlled trials investigating the efficacy of desmopressin acetate versus tranexamic acid or factor VIII or rFactor VII or fresh frozen plasma in preventing and treating congenital bleeding disorders during pregnancy were eligible.
No trials matching the selection criteria were eligible for inclusion.
No trials matching the selection criteria were eligible for inclusion.
The review did not identify any randomised controlled trials investigating the relative effectiveness of desmopressin acetate for bleeding during pregnancy in women with congenital bleeding disorders. In the absence of high quality evidence, clinicians need to use their clinical judgement and lower level evidence (e.g. from observational trials) to decide whether or not to treat women with congenital bleeding disorders with desmopressin acetate.Given the ethical considerations, future randomised controlled trials are unlikely. However, other high quality controlled studies (such as risk allocation designs, sequential design, parallel cohort design) to investigate the risks and benefits of using desmopressin acetate in this population are needed.
Background
Sickle cell disease is the most common single gene disorder and the commonest haemoglobinopathy found with high prevalence in many populations across the world. Management of dental ...complications in people with sickle cell disease requires special consideration for three main reasons. Firstly, dental and oral tissues are affected by the blood disorder resulting in several oro‐facial abnormalities. Secondly, living with a haemoglobinopathy and coping with its associated serious consequences may result in individuals neglecting their oral health care. Finally, the treatment of these oral complications must be adapted to the systemic condition and special needs of these individuals, in order not to exacerbate or deteriorate their general health.
Guidelines for the treatment of dental complications in this population who require special care are unclear and even unavailable in many aspects. Hence this review was undertaken to provide a basis for clinical care by investigating and analysing the existing evidence in the literature for the treatment of dental complications in people with sickle cell disease. This is an update of a previously published review.
Objectives
To assess methods of treating dental complications in people with sickle cell disease.
Search methods
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Review Group's Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference books.
Date of last search: 01 August 2019.
Additionally, we searched nine online databases (PubMed, Google Scholar, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, Literature in the Health Sciences in Latin America and the Caribbean database, African Index Medicus, Index Medicus for South East Asia Region, Index Medicus for the Eastern Mediterranean Region, Indexing of Indian Medical Journals). We also searched the reference lists of relevant articles and reviews and contacted haematologists, experts in fields of dentistry, organizations, pharmaceutical companies and researchers working in this field.
Date of last search: 07 November 2019.
Selection criteria
We searched for published or unpublished randomised controlled studies of treatments for dental complications in people with sickle cell disease.
Data collection and analysis
Two review authors intended to independently extract data and assess the risk of bias of the included studies using standard Cochrane methodologies; however, no studies were identified for inclusion in the review.
Main results
No randomised controlled studies were identified.
Authors' conclusions
This Cochrane Review did not identify any randomised controlled studies assessing interventions for the treatment of dental complications in people with sickle cell disease. There is an important need for randomised controlled studies in this area, so as to identify the most effective and safe method for treating dental complications in people with sickle cell disease.
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
The main objective of this review is to assess different methods to treat dental and orthodontic complications ...in people with thalassaemia.
The term 'dental complications' is used to represent all oral infections, diseases and conditions affecting the teeth, jaws, orofacial region and associated structures, such as dental caries, periodontal disease, odontogenic infections, osteomyelitis, cellulitis etc. Under 'orthodontic complications' we will include craniofacial deformities, jaw abnormalities, malocclusion or any other condition necessitating orthodontic and its adjunctive treatment procedures including orthognathic surgery.
Background
The gag reflex is an involuntary defence mechanism to protect the pharynx and throat from foreign objects. Gagging is a common problem encountered during dental treatment, making ...therapeutic procedures distressing and often difficult or even impossible to perform. Various interventions can be used to control the gag reflex: anti‐nausea medicines, sedatives, local and general anaesthetics, herbal remedies, behavioural therapies, acupressure, acupuncture, laser, and prosthetic devices. This is an update of the Cochrane Review first published in 2015.
Objectives
To assess the effects of pharmacological and non‐pharmacological interventions for the management of gagging in people undergoing dental treatment.
Search methods
Cochrane Oral Health's Information Specialist searched the Cochrane Oral Health's Trials Register (to 18 March 2019), the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 2) in the Cochrane Library (searched 18 March 2019), MEDLINE Ovid (1946 to 18 March 2019), Embase Ovid (1980 to 18 March 2019), CINAHL EBSCO (1937 to 18 March 2019), AMED Ovid (1985 to 18 March 2019), and the proceedings of the International Association for Dental Research (IADR) online (2001 to 18 March 2019). The US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. We also conducted forwards citation searching on the included studies via Google Scholar. No restrictions were placed on the language or date of publication when searching the electronic databases.
Selection criteria
We included randomised controlled trials (RCTs), involving people who were given a pharmacological or non‐pharmacological intervention to manage gagging that interfered with dental treatment. We excluded quasi‐RCTs. We excluded trials with participants who had central or peripheral nervous system disorders, who had oral lesions or were on systemic medications that might affect the gag sensation, or had undergone surgery which might alter anatomy permanently.
Data collection and analysis
We independently selected trials, extracted data, and assessed risk of bias. We followed Cochrane's statistical guidelines. We assessed the overall certainty of the evidence using GRADE.
Main results
We included four trials at unclear risk of bias with 328 participants (263 adults and 65 children who were four years or older), in which one trial compared acupuncture and acupressure (with thumb, device and sea band) at P6 (point located three‐finger breadths below the wrist on the inner forearm in between the two tendons) to sham acupuncture and acupressure with and without sedation. One trial compared acupuncture at P6 point to sham acupuncture. These trials reported both completion of dental procedure and reduction in gagging (assessor and patient reported) as their outcomes. One cross‐over and one split‐mouth trial studied the effect of laser at P6 point compared to control. One trial reported reduction in gagging and another reported presence or absence of gagging during dental procedure.
Acupuncture at P6 showed uncertain evidence regarding the successful completion of dental procedure (RR 1.78, 95% CI 1.05 to 3.01; two trials, 59 participants; very low‐certainty evidence) and uncertain evidence regarding the reduction in gagging (RR 2.57, 95% CI 1.12 to 5.89; one trial, 26 participants; very low‐certainty evidence) in comparison to sham acupuncture. Acupuncture at P6 with sedation did not show any difference when compared to sham acupuncture with sedation (RR 1.08, 95% CI 0.91 to 1.28; one trial, 34 participants; very low‐certainty evidence).
Acupressure using thumb pressure with or without sedation showed no clear difference in completing dental procedure (RR 0.96, 95% CI 0.84 to 1.10; one trial, 39 participants; very low‐certainty evidence; and RR 0.85, 95% CI 0.50 to 1.46; one trial, 30 participants; very low‐certainty evidence; respectively), or reduction in gagging (RR 1.06, 95% CI 0.92 to 1.23; one trial, 39 participants; very low‐certainty evidence; and RR 0.92, 95% CI 0.60 to 1.41; one trial, 30 participants; very low‐certainty evidence; respectively) when compared to sham acupressure with or without sedation.
Acupressure at P6 with device showed uncertain evidence regarding the successful completion of dental procedure (RR 2.63, 95% CI 1.33 to 5.18; one trial, 34 participants; very low‐certainty evidence) and uncertain evidence regarding the reduction in gagging (RR 3.94, 95% CI 1.63 to 9.53; one trial, 34 participants; very low‐certainty evidence) when compared to sham acupressure. However, device combined with sedation showed no difference for either outcome (RR 1.16, 95% CI 0.90 to 1.48; one trial, 27 participants; very low‐certainty evidence; and RR 1.26, 95% CI 0.93 to 1.69; one trial, 27 participants; very low‐certainty evidence; respectively).
Acupressure using a sea band with or without sedation showed no clear difference in completing dental procedure (RR 0.88, 95% CI 0.67 to 1.17; one trial, 21 participants; very low‐certainty evidence; and RR 1.80, 95% CI 0.63 to 5.16; one trial, 19 participants; very low‐certainty evidence; respectively), or reduction in gagging (RR 0.88, 95% CI 0.67 to 1.17; one trial, 21 participants; very low‐certainty evidence; and RR 2.70, 95% CI 0.72 to 10.14; one trial, 19 participants; very low‐certainty evidence; respectively) when compared to sham acupressure with or without sedation.
Laser at P6 showed a difference in absence of gagging (odds ratio (OR) 86.33, 95% CI 29.41 to 253.45; one trial, 40 participants; very low‐certainty evidence) and reduction in gagging (MD 1.80, 95% CI 1.53 to 2.07; one trial, 25 participants; very low‐certainty evidence) during dental procedure when compared to dummy laser application.
No noteworthy adverse effects were reported. For acupuncture at P6, the trial authors were unsure whether the reported adverse effects were due to participant anxiety or due to the intervention. None of the trials on acupressure or laser reported on this outcome.
We did not find trials evaluating any other interventions used to manage gagging in people undergoing dental treatment.
Authors' conclusions
We found very low‐certainty evidence from four trials that was insufficient to conclude if there is any benefit of acupuncture, acupressure or laser at P6 point in reducing gagging and allowing successful completion of dental procedures. We did not find any evidence on any other interventions for managing the gag reflex during dental treatment. More well‐designed and well‐reported trials evaluating different interventions are needed.
Background
Congenital bleeding disorders can cause obstetric haemorrhage during pregnancy, labour and following delivery. Desmopressin acetate (DDAVP) is found to be an effective drug which can ...reduce the risk of haemorrhage and can also stop bleeding in certain congenital bleeding disorders. Its use in pregnancy has been controversial. Hence beneficial and adverse effects of DDAVP in these groups of pregnant women should be evaluated.
This is an update of a Cochrane Review first published in 2013 and updated in 2015.
Objectives
To evaluate the efficacy and safety of DDAVP in preventing and treating acute bleeding in pregnant women with bleeding disorders.
Search methods
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coaguopathies Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant and books of conferences proceedings. We also searched several clinical trial registries and grey literature (27 August 2017).
Date of most recent search of the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coaguopathies Trials Register: 01 October 2018.
Selection criteria
Randomised and quasi‐randomised controlled trials investigating the efficacy of DDAVP versus tranexamic acid or factor VIII or rFactor VII or fresh frozen plasma in preventing and treating congenital bleeding disorders during pregnancy were eligible.
Data collection and analysis
No trials matching the selection criteria were eligible for inclusion.
Main results
No trials matching the selection criteria were eligible for inclusion.
Authors' conclusions
No randomised controlled trials were identified investigating the relative effectiveness of DDAVP for bleeding during pregnancy in women with congenital bleeding disorders. In the absence of high‐quality evidence, clinicians need to use their clinical judgement and lower level evidence (e.g. from observational trials) to decide whether or not to treat women with congenital bleeding disorders with DDAVP.
Given the ethical considerations, future randomised controlled trials are unlikely. However, other high‐quality controlled studies (such as risk allocation designs, sequential design, parallel cohort design) to investigate the risks and benefits of using DDAVP in this population are needed.
Given that there are unlikely to be any trials published in this area, this review will no longer be regularly updated.
Background
During pregnancy, a Rhesus‐negative (Rh‐negative) woman may develop antibodies if her fetus is Rh‐positive, which can cause fetal morbidity or mortality in following pregnancies, if ...untreated.
Objectives
To assess the effects of administering anti‐D immunoglobulin (Ig) after spontaneous miscarriage in a Rh‐negative woman, with no anti‐D antibodies.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 December 2012).
Selection criteria
Randomised controlled trials (RCT) in Rh‐negative women without antibodies who were given anti‐D Ig following spontaneous miscarriage compared with no treatment or placebo treatment following spontaneous miscarriage as control.
Data collection and analysis
Two review authors independently assessed trials for inclusion and trial quality. Two review authors extracted data and checked it for accuracy.
Main results
We included one RCT, involving 48 women who had a miscarriage between eight to 24 weeks of gestation. Of the 19 women in the treatment group, 14 had therapeutic dilatation & curettage (D&C) and five had spontaneous miscarriage; of the 29 women in the control group, 25 had therapeutic D&C and four had spontaneous miscarriage. The treatment group received 300 µg anti‐D Ig intramuscular injection and were compared with a control group who received 1 cc homogenous gamma globulin placebo.
This review's primary outcomes (development of a positive Kleihauer Betke test (a test that detects fetal cells in the maternal blood; and development of RhD alloimmunisation in a subsequent pregnancy) were not reported in the included study.
Similarly, none of the review's secondary outcomes were reported in the included study: the need for increased surveillance for suspected fetal blood sampling and fetal transfusions in subsequent pregnancies, neonatal morbidity such as neonatal anaemia, jaundice, bilirubin encephalopathy, erythroblastosis, prematurity, hypoglycaemia (low blood sugar) in subsequent pregnancies, maternal adverse events of anti‐D administration including anaphylactic reaction and blood‐borne infections.
The included study did report subsequent Rh‐positive pregnancies in three women in the treatment group and six women in the control group. However, due to the small sample size, the study failed to show any difference in maternal sensitisation or development of Rh alloimmunisation in the subsequent pregnancies.
Authors' conclusions
There are insufficient data available to evaluate the practice of anti‐D administration in an unsensitised Rh‐negative mother after spontaneous miscarriage. Thus, until high‐quality evidence becomes available, the practice of anti‐D Immunoglobulin prophylaxis after spontaneous miscarriage for preventing Rh alloimmunisation cannot be generalised and should be based on the standard practice guidelines of each country.
Bleeding disorders are uncommon but may pose significant bleeding complications during pregnancy, labour and following delivery for both the woman and the foetus. While many bleeding disorders in ...women tend to improve in pregnancy, thus decreasing the haemorrhagic risk to the mother at the time of delivery, some do not correct or return quite quickly to their pre-pregnancy levels in the postpartum period. Therefore, specific measures to prevent maternal bleeding and foetal complications during childbirth, are required. The safest method of delivery to reduce morbidity and mortality in these women is controversial.
To assess the optimal mode of delivery in women with, or carriers of, bleeding disorders.
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Coagulopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the Cochrane Pregnancy and Childbirth Group's Trials Register as well as trials registries and the reference lists of relevant articles and reviews.Date of last search of the Group's Trials Registers: 13 January 2015.
Randomised controlled trials and all types of controlled clinical trials investigating the optimal mode of delivery in women with, or carriers of, any type of bleeding disorder during pregnancy were eligible for the review.
No trials matching the selection criteria were eligible for inclusion
No results from randomized controlled trials were found.
The review did not identify any randomised controlled trials investigating the safest mode of delivery and associated maternal and foetal complications during delivery in women with, or carriers of, a bleeding disorder. In the absence of high quality evidence, clinicians need to use their clinical judgement and lower level evidence (e.g. from observational trials, case studies) to decide upon the optimal mode of delivery to ensure the safety of both mother and foetus.Given the ethical considerations, the rarity of the disorders and the low incidence of both maternal and foetal complications, future randomised controlled trials to find the optimal mode of delivery in this population are unlikely to be carried out. Other high quality controlled studies (such as risk allocation designs, sequential design, and parallel cohort design) are needed to investigate the risks and benefits of natural vaginal and caesarean section in this population or extrapolation from other clinical conditions that incur a haemorrhagic risk to the baby, such as platelet alloimmunisation.
Full text
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NUK, OILJ, UL, UM, UPUK, VSZLJ
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