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
NCT number | NCT04896450 |
Other study ID # | ORTHO-GTR |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | December 2022 |
Verified date | February 2023 |
Source | Semmelweis University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Hungary | Semmelweis University Department of Periodontology | Budapest |
Lead Sponsor | Collaborator |
---|---|
Semmelweis University | Geistlich Pharma AG, Schupbach Ltd. |
Hungary,
Araujo MG, Carmagnola D, Berglundh T, Thilander B, Lindhe J. Orthodontic movement in bone defects augmented with Bio-Oss. An experimental study in dogs. J Clin Periodontol. 2001 Jan;28(1):73-80. doi: 10.1034/j.1600-051x.2001.280111.x. — View Citation
Cardaropoli D, Re S, Manuzzi W, Gaveglio L, Cardaropoli G. Bio-Oss collagen and orthodontic movement for the treatment of infrabony defects in the esthetic zone. Int J Periodontics Restorative Dent. 2006 Dec;26(6):553-9. — View Citation
Reichert C, Deschner J, Kasaj A, Jager A. Guided tissue regeneration and orthodontics. A review of the literature. J Orofac Orthop. 2009 Jan;70(1):6-19. doi: 10.1007/s00056-009-0814-1. Epub 2009 Feb 5. English, German. — View Citation
Reynolds MA, Aichelmann-Reidy ME, Branch-Mays GL, Gunsolley JC. The efficacy of bone replacement grafts in the treatment of periodontal osseous defects. A systematic review. Ann Periodontol. 2003 Dec;8(1):227-65. doi: 10.1902/annals.2003.8.1.227. — View Citation
Zucchelli G, De Sanctis M. A novel approach to minimizing gingival recession in the treatment of vertical bony defects. J Periodontol. 2008 Mar;79(3):567-74. doi: 10.1902/jop.2008.070315. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Amount of newly formed bone by means of histomorphometry | 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 | 9 months postoperatively | |
Primary | Amount of graft material by means of histomorphometry | 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 | 9 months postoperatively | |
Primary | Amount of connective tissue by means of histomorphometry | The percentage of connective tissue of the former periodontal defect after a biopsy harvesting during a reentry surgery 9 months after the GTR intervention | 9 months postoperatively | |
Secondary | CAL | Clinical attachment level gain | 9 months postoperatively | |
Secondary | PPD | Pocket probing depth reduction | 9 months postoperatively | |
Secondary | GR | Change in gingival recession | 9 months postoperatively | |
Secondary | Bone gain | The absolute fill of the periodontal defect | 9 months postoperatively | |
Secondary | Bone loss | The change of the crestal bony wall | 9 months postoperatively | |
Secondary | Intrabony fill | The change of the intrabony component compared to the initial intrabony defect depth (in percentage) | 9 months postoperatively |
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