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Comparison of the GTR Procedure Alone and in Combination With Immediate OTM

Intrabony Periodontal Defect Clinical Trial

Official title:
Comparison of the Guided Tissue Regeneration (GTR) Procedure Alone and in Combination With Immediate Orthodontic Tooth Movement (OTM) in the Treatment of Non-containing and Wide Intrabony Periodontal Defects: a Prospective RCT

Clinical Trial Summary

The aim is to evaluate in a prospective, randomized, controlled clinical study the healing of a GTR procedure, when it is combined with an immediate orthodontic tooth movement or used alone. Clinical, radiological and reentry (histological) evaluation of a regenerative surgical method (GTR + grafting material) with different postsurgical healing patterns in the treatment of wide, non-containing intrabony defects.

Clinical Trial Description

There is limited histological data in literature on the behavior of xenogeneic graft materials in intrabony defects used in periodontal regenerative therapy followed by orthodontic tooth movement (OTM). This clinical study aims to clinically and histologically evaluate the healing response of the periodontal tissues and the healing pattern of a non-resorbable graft material, when they are exposed to orthodontic forces. Therefore teeth presenting non-contained intrabony defects in combination with pathologic tooth migration (PTM) are included in this prospective clinical study. Guided tissue regeneration (GTR) with the application of deproteinized bovine bone mineral (DBBM) and a resorbable collagen membrane is utilized to surgically treat the periodontal defects, which is followed by a random allocation of the patients into test or control group. Subject teeth undergo an early initiated orthodontic treatment after surgery or stay splinted without any tooth movement in the latter groups, respectively. Teeth in test group can be further divided into subgroups, depending if they are moved toward to the former defect (pressure site) or moved away from the defect (tension site). After 9 months of healing a reentry surgery is performed, when a biopsy core is removed with a microtrephine from the previous defect site. The sample is evaluated by means of histology supplemented with histomorphometry, which is the primary outcome variable. Periodontal clinical parameters measured at baseline and at 9 months serves for secondary outcomes. Several studies confirmed the success of graft materials in such comprehensive treatment approaches clinically, but we lack the human histologically proved data, whether DBBM bone substitute can be used safely when the tooth is exposed to OTM. Our main question is how orthodontic induced bone remodelling interferes with these graft particles, can they heal the same or even better compared to control sites. Tissue response might be different also in the case of the two test subgroups. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04896450
Study type Interventional
Source Semmelweis University
Contact
Status Completed
Phase N/A
Start date September 2015
Completion date December 2022
View Details
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