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 Details — Status: Completed

Administrative data

• NCT number: NCT04896450
• Other study ID #: ORTHO-GTR
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: December 2022

Study information

• Verified date: February 2023
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Intrabony Periodontal Defect

Intervention

Procedure:
• Guided tissue regeneration (GTR)
GTR is handled with the utilization of a coronally advanced flap, followed by a thorough debridement of the denudated root surface and the intrabony component. Regenerative materials are resorbable collagen membrane (BioGide, Geistlich Phara AG, Wolhusen, Switzerland) and deproteinized bovine bone mineral (BioOss, Geistlich Phara AG), finally surgery is finished with multilayer suturing technique.

Device:
• Orthodontic tooth movement (OTM)
An early initialization of the tooth movement with the help of a multibond fixed orthodontic device utilizing low level of continuous orthodontic forces.

Locations

Country	Name	City	State
Hungary	Semmelweis University Department of Periodontology	Budapest

Sponsors (3)

Lead Sponsor	Collaborator
Semmelweis University	Geistlich Pharma AG, Schupbach Ltd.

Country where clinical trial is conducted

Hungary, 

References & Publications (5)

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

Outcome

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