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

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

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.

Study Overview

• Status: Completed
• Conditions: Intrabony Periodontal Defect
• Intervention / Treatment: Procedure: Guided tissue regeneration (GTR); Device: Orthodontic tooth movement (OTM)

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1088
    • Semmelweis University Department of Periodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; Test subjects receive GTR and early initiation of OTM.	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.; Other Names: Regenerative surgery of an intrabony periodontal defect; 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.; Other Names: Multibond fixed orthodontic appliance
Active Comparator: Control group; Control subjects receive only GTR.	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.; Other Names: Regenerative surgery of an intrabony periodontal defect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Semmelweis University
• Collaborators: Geistlich Pharma AG; Schupbach Ltd.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 18, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: histology; orthodontic tooth movement; bone remodeling; guided tissue regeneration; deproteinized bovine bone mineral
• Other Study ID Numbers: ORTHO-GTR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No