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

Not Applicable

Completed

• Conditions: Intrabony Periodontal Defect
• Interventions: Procedure: Guided tissue regeneration (GTR); Device: Orthodontic tooth movement (OTM)

• Registration Number: NCT04896450
• Lead Sponsor: Semmelweis University

Brief 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.

Detailed 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 Timeline

• Study Start: 2015-09
• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-21
• Primary Completion: 2022-12
• Study Completion: 2022-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-18
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Periodontitis with intrabony defect (Intrabony component ≥ 4mm, defect radiological angulation > 25°, 1 or max. 2 bony walls (no buccal bony wall), non-containing defect), no class III. furcation involved teeth
• Selected tooth must be in a traumatic occlusion or not in a gnathologically correct bite (migrated, elongated, tilted tooth, etc.).
• Patients must not be heavy smokers (<5 cigarettes/day).
• Full mouth plaque and bleeding scores (FMPS and FMBS) of <20% (O'Leary et al. 1972).
• The patient is able to comply with the study -related procedures (i.e. good level of oral hygiene, follow-up procedures).
• The patient is able to fully understand the nature of the study, signed informed consent.

Exclusion Criteria

• Pregnant women.
• Participation in another clinical study within 30 days prior to study start.
• Alcoholism, drug dependency, heavy smoking (>5 cigarettes/day).
• Known infection with HIV, HBV, or HCV.
• Patients requiring chemo- or radiotherapy.
• Previous or current radiotherapy of the head.
• Uncontrolled or insulin-dependent diabetes mellitus
• Clinically relevant osteoporosis or systemic disease affecting bone metabolism
• Clinically relevant cardiovascular disease e.g., decompensated cardiac insufficiency, hemodynamically relevant heart valve defects, or myocardial infarction during the last three months.
• Clinically relevant blood coagulation disorder.
• Previous or current treatment with systemic corticosteroids (within 2 months prior to screening visit) of more than 5 mg/day prednisone equivalent.
• Previous or current therapy with bisphosphonates at least for 30 days within the last 12 months before screening visit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Guided tissue regeneration (GTR)	Control subjects receive only GTR.
Test group	Orthodontic tooth movement (OTM)	Test subjects receive GTR and early initiation of OTM.
Test group	Guided tissue regeneration (GTR)	Test subjects receive GTR and early initiation of OTM.

Primary Outcome Measures

Name	Time	Method
Amount of graft material by means of histomorphometry	9 months postoperatively	The percentage of graft material (BioOss, Geistlich Pharma AG, Wolhusen) of the former periodontal defect after a biopsy harvesting during a reentry surgery 9 months after the GTR intervention
Amount of newly formed bone by means of histomorphometry	9 months postoperatively	The percentage of newly formed bone of the former periodontal defect after a biopsy harvesting during a reentry surgery 9 months after the GTR intervention
Amount of connective tissue by means of histomorphometry	9 months postoperatively	The percentage of connective tissue of the former periodontal defect after a biopsy harvesting during a reentry surgery 9 months after the GTR intervention

Secondary Outcome Measures

Name	Time	Method
PPD	9 months postoperatively	Pocket probing depth reduction
GR	9 months postoperatively	Change in gingival recession
Bone loss	9 months postoperatively	The change of the crestal bony wall
Intrabony fill	9 months postoperatively	The change of the intrabony component compared to the initial intrabony defect depth (in percentage)
Bone gain	9 months postoperatively	The absolute fill of the periodontal defect
CAL	9 months postoperatively	Clinical attachment level gain

Trial Locations

Locations (1)

Semmelweis University Department of Periodontology; 🇭🇺 Budapest, Hungary