Aim
To evaluate the non‐inferiority of the adjunct of a xenogeneic collagen matrix (CMX) or connective tissue graft (CTG) to coronally advanced flaps (CAF) for coverage of multiple adjacent ...recessions and compare superiority in patient‐reported outcomes (PROM).
Material and methods
One hundred and eighty‐seven subjects (92 CMX) with 485 recessions in 14 centres were randomized and followed up for 6 months. Patients filled daily diaries for 15 days to monitor patient‐reported experience. The primary outcome was changed in position of the gingival margin. Multilevel analysis used centre, subject and tooth as levels and baseline parameters as covariates.
Results
Average baseline recession was 2.5 ± 1.0 mm. The surgery was 15.7 min shorter (95%CI from 11.9 to 19.6, p < .0001) and perceived lighter (11.9 VAS units, 95%CI from 4.6 to 19.1, p = .0014) in CMX subjects. Time to recovery was 1.8 days shorter in CMX. Six‐month root coverage was 1.7 ± 1.1 mm for CMX and 2.1 ± 1.0 mm for CTG (difference of 0.44 mm, 95%CI from 0.25 to 0.63 mm). The upper limit of the confidence interval was over the non‐inferiority margin of 0.25 mm. Odds of complete root coverage were significantly higher for CTG (OR = 4.0, 95% CI 1.8–8.8).
Conclusion
Replacing CTG with CMX shortens time to recovery and decreases morbidity, but the tested generation of devices is probably inferior to autologous CTG in terms of root coverage. Significant variability in PROMs was observed among centres.
Aim
To compare need for bone augmentation, surgical complications, periodontal, radiographic, aesthetic and patient reported outcomes in subjects receiving implant placement at the time of extraction ...(Immediate Implant) or 12 weeks thereafter.
Methods
Subjects requiring single tooth extraction in the anterior and premolar areas were recruited in seven private practices. Implant position and choice of platform were restoratively driven. Measurements were performed by calibrated and masked examiners.
Results
IMI was unfeasible in 7.5% of cases. One hundred and 24 subjects were randomized. One implant was lost in the IMI group. IMI required bone augmentation in 72% of cases compared with 43.9% for delayed (p = 0.01), while wound failure occurred in 26.1% and 5.3% of cases, respectively (p = 0.02). At 1 year, IMI had deeper probing depths (4.1 ± 1.2 mm versus 3.3 ± 1.1 mm, p < 0.01). A trend for greater radiographic bone loss was observed at IMI over the initial 3‐year period (p‐trend < 0.01). Inadequate pink aesthetic scores were obtained in 19% of delayed and in 42% of IMI implant cases (p = 0.03). No differences in patient reported outcomes were observed.
Conclusions
Immediate implant placement should not be recommended when aesthetics are important, IMI should be limited to selected cases. Longer follow‐up is needed to assess differences in complication rates.
A dome‐shaped bioresorbable membrane was fixed to the wounded rabbit calvaria and filled with a bioresorbable fibre conglomerate. After 4 weeks, the histologic preparation revealed an intimate ...spatial and temporal correlation between newly formed blood vessels and de novo extraskeletal bone formation. These observations emnhasize the sipnificance of angiogenesis in guided bone generation.
Background
Surface modification may yield enhanced soft tissue adhesion to transmucosal titanium implant necks.
Aim
To evaluate and compare changes in soft tissues around implants with a modified ...hydrophilic sandblasted and acid‐etched neck (mSLA; test) to those with a machined neck (M; control).
Materials and methods
Implants with a diameter of 4.1 mm and a neck height of 1.8 mm were randomly inserted in healed sites with pristine bone of the posterior maxilla or mandible. The modified Sulcus Bleeding Index (mSBI) (primary outcome) was assessed at baseline (BL) and 6, 12 and 36 months. Secondary outcomes included the assessment of pocket probing depth (PPD), mucosal recession (REC) and clinical attachment level (CAL). Standardized radiographs were taken at time of implant placement, at BL and after 12 and 36 months.
Results
Of the 43 randomized subjects, 38 (19 test and 19 controls) completed the 36‐month follow‐up. Implant survival rates amounted to 95.5% (test) and 100% (control) (p > .05). At 36 months, 77.6% of test implants and 78.9% of control implants were without any bleeding sites (mSBI = 0; p > .05). The 36‐month success rate was 86.4% in the test and 85.7% in the control group, respectively (p > .05). At 36 months, the mean radiographic bone level change from BL was 0.33 ± 0.69 mm at test implants and 0.12 ± 0.3 mm at control implants (p > .05).
Conclusion
Tissue level implants with a hydrophilic mSLA transmucosal neck failed to yield clinical and radiographic benefits compared with implants with a machined neck up to 3 years.
Objectives
To evaluate the efficacy of a slow release doxycycline gel (SRD) adjunctively administered to non‐surgical therapy in subjects with recurrent or persistent periodontitis but acceptable ...oral hygiene during supportive periodontal care.
Material & methods
In this single blind, parallel group, multicentre study, 202 of 203 recruited periodontal maintenance subjects with recurrent or persistent periodontitis were randomly assigned to subgingival ultrasonic/sonic instrumentation (USI) with (test) or without (control) subsequent administration of SRD in all residual periodontal pockets ≥4 mm. Intergroup differences in probing depth, BOP reductions, treatment time, probing attachment levels were evaluated at 3, 6 and 12 months. The primary outcome was the inter‐group difference in absolute change of probing pocket depth (PPD) 3, 6 and 12 months after intervention.
Results
At baseline, the two groups were comparable. At 3 months, the test group showed a significantly higher decrease in mean probing depth than the control group at 3 months (mean difference = 0.11 mm, 95% CI 0.03–0.19 mm, p = 0.003). Administration of SRD resulted in significantly greater odds of transition of bleeding pockets ≥5 mm to a category of non bleeding sites with PPD ≤4 mm at 3 and 6 months (O.R. = 1.4, 95% CI 1.2–1.8 at 3 months). At 6 months, SRD benefit was observed only in the deeper pockets. 7.5% of subjects (no significant difference between test and control) showed disease progression (attachment loss ≥2 mm) and were exited from the study. No difference in the incidence of adverse events was observed between groups.
Conclusion
The trial results show that topically administered SRD may provide short‐term benefit in controlling inflammation and deep pockets in treated periodontal patients participating in a secondary prevention programme and able to maintain a satisfactory level of oral hygiene.
The purpose of this study was to examine the success rate of paramedian palatal Orthosystem first- and second-generation implants used for anchorage in orthodontic treatment in patients treated by ...one experienced orthodontist. The records of 143 patients (90 female, 53 male, median age: 15.7 years, range: 10.2-50.9) receiving 145 palatal implants of the first or second generation (Orthosystem, Straumann AG, Basel, Switzerland) were examined. All the palatal implants were placed in a paramedian palatal location by three experienced surgeons. Stable implants were orthodontically loaded after a healing period of 3 months. Out of the 145 inserted paramedian palatal implants only seven implants (4.8%) were not considered stable after insertion. All the successfully osseointegrated implants remained stable during orthodontic treatment. Paramedian palatal implants are highly reliable and effective devices to obtain skeletal anchorage for orthodontic treatment. This study has shown that the paramedian location is a good alternative to the median location.
Abstract
Aim:
This prospective multicentre randomized controlled clinical trial was designed to compare the clinical outcomes of papilla preservation flap surgery with or without the application of ...enamel matrix proteins (EMD).
Material and methods:
172 patients with advanced chronic periodontitis were recruited in 12 centers in 7 countries. All patients had at least one intrabony defect of 3mm. Heavy smokers (20 cigarettes/day) were excluded. The surgical procedures included access for root instrumentation using either the simplified or the modified papilla preservation flap in order to obtain optimal tissue adaptation and primary closure. After debridement, roots were conditioned for 2 min with a gel containing 24% EDTA. EMD was applied in the test subjects, and omitted in the controls. Postsurgically, a strict plaque control protocol was followed. At baseline and 1 year following the interventions, clinical attachment levels (CAL), pocket probing depths (PPD), recession (REC), full‐mouth plaque scores and full‐mouth bleeding scores were assessed. A total of 166 patients were available for the 1‐year follow‐up.
Results:
At baseline, 86 test and 86 control patients presented with similar subject and defect characteristics. On average, the test defects gained 3.1±1.5 mm of CAL, while the control defects yielded a significantly lower CAL gain of 2.5±1.5 mm. Pocket reduction was also significantly higher in the test group (3.9±1.7 mm) when compared to the controls (3.3±1.7 mm). A multivariate analysis indicated that the treatment, the clinical centers, cigarette smoking, baseline PPD, and defect corticalisation significantly influenced CAL gains. A frequency distribution analysis of the studied outcomes indicated that EMD increased the predictability of clinically significant results (CAL gains 4 mm) and decreased the probability of obtaining negligible or no gains in CAL (CAL gains <2 mm).
Conclusions:
The results of this trial indicated that regenerative periodontal surgery with EMD offers an additional benefit in terms of CAL gains, PPD reductions and predictability of outcomes with respect to papilla preservation flaps alone.
Zusammenfassung
Ziel:
Diese prospektive multizentrische randomisierte klinisch kontrollierte Studie wurde geplant, um die klinischen Ergebnisse der Papillenschonungstechnik bei der Lappenoperation mit und ohne zusätzliche Applikation von Schmelzmatrixproteinen (EMD) zu vergleichen.
Material und Methoden:
172 Patienten mit fortgeschrittener chronischer Parodontitis wurden in 12 Zentren in 7 Ländern hinzugezogen. Alle Patienten hatten mindestens einen intraalveolären Defekt 3 mm. Starke Raucher (20 Zigaretten/Tag) wurden ausgeschlossen. Die chirurgischen Prozeduren schlossen den Zugang für die instrumentelle Wurzeloberflächenbearbeitung entweder unter Nutzung einer einfachen oder der modifizierten Papillenschonungstechnik und Lappenbildung ein, um eine optimale Gewebeadaptation und einen primären Naht‐jyverschluss zu erzielen. Nach der Wurzelreinigung und ‐glättung wurden die Wurzeln für 2 Minuten mit einem Gel, das 24% EDTA enthielt, konditioniert. EMD wurde bei den Testpersonen verwendet, bei den Kontrollen nicht. Postoperativ wurde eine strenge Plaquekontrolle durchgeführt. Zur Basis und 1 Jahr nach der Intervention wurden die klinischen Stützgewebeniveaus (CAL), die Sondierungstiefen (PPD), die Rezessionen (REC), die vollständigen Plaquewerte und die vollständigen Blutungswerte aufgezeichnet. Insgesamt standen noch 166 Patienten nach 1 Jahr zur Verfügung.
Ergebnisse:
Zur Basis zeigten die 86 Test‐ und 86 Kontrollpersonen ähnliche Persönlichkeits‐ und Defektcharakteristiken. Im Durchschnitt gewannen die Testdefekte 3.1±1.5 mm CAL, während die Kontrolldefekte einen signifikant geringeren CAL Gewinn von 2.5±1.5 mm aufwiesen. Die Reduktion der Sondierungstiefen war auch signifikant höher in der Testgruppe (3.9±1.7 mm), wenn mit den Kontrollen verglichen wurde (3.3±1.7 mm). Eine multivariate Analyze zeigte, dass die Behandlung, das klinische Zentrum, das Zigarettenrauchen, die anfängliche PPD und die Defektkortikalisation den CAL Gewinn signifikant beeinflusste. Eine Häufigkeitsanalyse der klinischen Ergebnisse zeigte, dass EMD die Vorhersagbarkeit von klinischen signifikanten Ergebnissen (CAL Gewinn 4 mm) vergrößerte und die Wahrscheinlichkeit von unwesentlichen oder keinen Gewinn von CAL (CAL Gewinn <2 mm) verringerte.
Schlussfolgerungen:
Die Ergebnisse dieser Studie zeigten, dass die regenerative parodontale Chirurgie mit EMD einen zusätzlichen Nutzen in Form des CAL Gewinns, der PPD Reduktion und der Vorhersagbarkeit der Ergebnisse in Beziehung zur Lappenoperation mit Papillenschonungstechnik allein erbringt.
Résumé
But:
Cette étude clinique contrôlée, au hasard, multicentrique et prospective a été effectuée pour comparer les effets cliniques de la chirurgie par lambeau de préservation de la papille avec ou sans l'application des protéines dérivées de la matrice amélaire (EMD).
Matériaux et méthodes:
172 patients avec parodontite chronique avancée ont été recrutés parmi 12 centres de 7 pays. Tous les patients avaient au moins une lésion osseuse 3 mm. Les grands fumeurs (20 cigarettes (jour) ont été exclus. Les procédures chirurgicales comprenaient l'accès pour l'instrumentation radiculaire en utilisant soit le lambeau de préservation papillaire simplifié ou modifié afin d'obtenir l'adaptation tissulaire optimale en fin d'opération. Après le nettoyage, les surfaces radiculaires ont été conditionnées pendant 2 min avec un gel contenant 24% d'EDTA, EMD appliqué chez les sujets tests et omis chez les contrôles. Après la chirurgie, un contrôle de plaque dentaire strict a été imposé. Lors de l'examen initial et une année après la chirurgie, les niveaux d'attache clinique (CAL), les profondeurs de poche au sondage (PPD), la récession (REC), les scores de plaque dentaire et les scores de saignement de l'ensemble de la bouche ont été relevés. En tout, 166 patients ont été revus après une année.
Résultats:
Lors de l'examen initial, les 86 patients tests et les 86 contrôles présentaient des lésions semblables. En moyenne, les lésions tests gagnaient 3.1±1.5 mm de CAL et les contrôles que 2.5±1.5 mm. La réduction des poches était également plus importante dans le groupe test (3.9±1.7 mm) comparée aux contrôles (3.3±1.7 mm). Une analyse multivariée a indiqué que le traitement, les centres cliniques, le tabagisme, le PPD lors de l'examen initial et la corticalisation de la lésion influençaient significativement les gains CAL. L'analyse de répartition de fréquence des données étudiées a indiqué que l'EMD augmentait la prévision des résultats cliniques (gain CAL 4 mm) et diminuait la probabilité de n'obtenir aucun gain ou des gains négligeables de CAL (gain de CAL <2 mm).
Conclusions:
Les résultats de cet essai ont indiqué que la chirurgie parodontale régénérative avec l'EMD offrait un bénéfice supplémentaire en terme de gain CAL, de réduction PPD et de prévision des données par rapport à une chirurgie par lambeau préservant la papille.
The aim of this investigation was to evaluate the performance of Straumann Bone Level SLActive implants in various clinical situations in daily dental practice for up to 3 years.
This was a ...prospective, multicenter, non-interventional study in which implants were placed within approved indications in any situation deemed suitable by the treating clinician. No implant placement or loading protocol was specified, and implants were placed according to the routine treatment protocols at each participating center.
In this analysis, data were available from 342 implants in 233 patients in three countries (USA, Canada, and Switzerland). One or two implants were placed in the majority of patients (70.8% and 19.3%, respectively), mostly in the maxilla (71.3%); almost half (47.7%) were placed in the esthetic zone. Implant placement after 4 to > 16 weeks of healing was preferred in Switzerland (92.0%), while 42.0% of implants were placed immediately in the USA and Canada. A flapless procedure was performed in 25.2% of cases in the USA and Canada, compared to 0.5% in Switzerland. Cumulative implant survival and success rates after 3 years were 97.5% and 93.5%, respectively.
Straumann Bone Level Implants can achieve favorable outcomes and high survival rates after 3 years in daily dental practice. The survival and success rates were comparable with those achieved in formal controlled clinical trials.
Clinical studies to assess dental implants are common in implantology, but such studies are usually performed for specific indications and following a specific protocol with strict inclusion and ...exclusion criteria. The aim of the current study was to evaluate the Straumann Bone Level SLActive dental implant in a prospective, multicenter, noninterventional trial.
The implant could be used in whatever manner was deemed suitable by the clinician, within approved indications. No particular placement or loading protocol was specified. A total of 1,532 implants were placed in 852 patients in 123 centers in nine countries in the US and Europe. After exclusion of three countries due to patient enrollment and data issues, 759 patients with 1,355 implants were analyzed.
Most patients received one or two implants (58.6% and 25.3% of patients, respectively), and 90% of cases were performed with a raised flap. A submerged healing protocol was significantly more prevalent in European centers, while transmucosal healing was significantly more prevalent in North American centers. After 1 year, 538 patients with 908 implants were available for evaluation. The cumulative implant survival and success rates were 98.5% and 96.0%, respectively.
This prospective noninterventional study evaluated the use of Straumann Bone Level SLActive dental implants in a large number of patients. The cumulative survival and success rates were similar to those observed in controlled clinical trials, confirming this dental implant's clinical applicability in daily practice.
This prospective multicenter randomized controlled clinical trial was designed to compare the clinical outcomes of papilla preservation flap surgery with or without the application of a guided tissue ...regeneration (GTR)/bone replacement material.
One hundred and twenty-four patients with advanced chronic periodontitis were recruited in 10 centers in seven countries. All patients had at least one intrabony defect of > or = 3 mm. The surgical procedures included access for root instrumentation using either the simplified or the modified papilla preservation flap in order to obtain optimal tissue adaptation and primary closure. After debridement, the regenerative material was applied in the test subjects, and omitted in the controls. At baseline and 1 year following the interventions, clinical attachment levels (CALs), probing pocket depths (PPDs), recession, full-mouth plaque scores and full-mouth bleeding scores (FMBS) were assessed.
One year after treatment, the test defects gained 3.3 +/- 1.7 mm of CAL, while the control defects yielded a significantly lower CAL gain of 2.5 +/- 1.5 mm. Pocket reduction was also significantly higher in the test group (3.7 +/- 1.8 mm) when compared with the controls (3.2 +/- 1.5 mm). A multivariate analysis indicated that the treatment, the clinical centers, baseline PPD and baseline FMBS significantly influenced CAL gains. Odds ratios (ORs) of achieving above-median CAL gains were significantly improved by the test procedure (OR = 2.6, 95% CI 1.2-5.4) and by starting with deeper PPD (OR = 1.7, 1.3-2.2) but were decreased by receiving treatment at the worst-performing clinical center (OR = 0.9, 0.76-0.99).
The results of this trial indicated that regenerative periodontal surgery with a GTR/bone replacement material offers an additional benefit in terms of CAL gains, PPD reductions and predictability of outcomes with respect to papilla preservation flaps alone.
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