Journal of periodontology · 2021
Efficacy of inorganic bovine bone combined with leukocyte and platelet-rich fibrin or collagen membranes for treating unfavorable periodontal infrabony defects: Randomized non-inferiority trial.
Equivalence TrialСтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Rexhepi Imena, Paolantonio Michele, Romano Luigi, Serroni Matteo, Santamaria Pasquale, Secondi Lorenzo, Paolantonio Giulia, Sinjari Bruna, De Ninis Paolo, Femminella Beatrice
Аннотация
BACKGROUND: Growing evidence shows the efficacy of platelet concentrates in periodontal therapy. This study aimed to demonstrate that an inorganic bovine bone graft (IBB) in combination with a leukocyte and platelet rich fibrin (L-PRF) is non-inferior to a combination with a collagen membrane (CM) when managing unfavorable infrabony defects (IBDs).
METHODS: All patients exhibited at least one unfavorable IBD; they were randomly assigned to two groups, 31 treated with L-PRF+IBB and 31 with CM+IBB. A clinical and radiographic examination was performed at baseline and 12 months later. Clinical attachment level (CAL), gingival recession (GR), probing depth (PD), and radiographic defect bone level (DBL) post-therapy changes were compared between the two treatments. A non-inferiority margin = 1 mm was set to determine the efficacy of the test treatment (-1 mm for GR); a second non-inferiority margin = 0.5 mm (-0.5 mm for GR) was chosen for clinical relevance.
RESULTS: Twelve months after surgery a significant improvement of clinical and radiographic parameters was observed at both experimental sites. The 90% confidence intervals of the CM+IBB-L-PRF+IBB mean difference for CAL gain (-0.810 mm [-1.300 to -0.319]) and DBL gain (-0.648 mm [-1.244 to -0.052]) were below the 0.5 mm non-inferiority margin; GR increase (1.284 mm [0.764 to 1.804]) remained above the -0.5 mm, while PD reduction (0.499 mm [0.145 to 0.853]) crossed its 0.5-mm margin.
CONCLUSIONS: The L-PRF+IBB treatment of unfavorable IBDs offers non-inferior efficacy for CAL gain, showing less GR and more DBL gain too, while for PD reduction it is inferior to the CM+IBB treatment.
METHODS: All patients exhibited at least one unfavorable IBD; they were randomly assigned to two groups, 31 treated with L-PRF+IBB and 31 with CM+IBB. A clinical and radiographic examination was performed at baseline and 12 months later. Clinical attachment level (CAL), gingival recession (GR), probing depth (PD), and radiographic defect bone level (DBL) post-therapy changes were compared between the two treatments. A non-inferiority margin = 1 mm was set to determine the efficacy of the test treatment (-1 mm for GR); a second non-inferiority margin = 0.5 mm (-0.5 mm for GR) was chosen for clinical relevance.
RESULTS: Twelve months after surgery a significant improvement of clinical and radiographic parameters was observed at both experimental sites. The 90% confidence intervals of the CM+IBB-L-PRF+IBB mean difference for CAL gain (-0.810 mm [-1.300 to -0.319]) and DBL gain (-0.648 mm [-1.244 to -0.052]) were below the 0.5 mm non-inferiority margin; GR increase (1.284 mm [0.764 to 1.804]) remained above the -0.5 mm, while PD reduction (0.499 mm [0.145 to 0.853]) crossed its 0.5-mm margin.
CONCLUSIONS: The L-PRF+IBB treatment of unfavorable IBDs offers non-inferior efficacy for CAL gain, showing less GR and more DBL gain too, while for PD reduction it is inferior to the CM+IBB treatment.