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

NCT04896450 | Completed DMC

• 1 other identifier: ORTHO-GTR
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrabony Periodontal Defect

Keywords

guided tissue regeneration; orthodontic tooth movement; histology; bone remodeling; deproteinized bovine bone mineral

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• CAL

  9 months postoperatively

• PPD

  9 months postoperatively

• GR

  9 months postoperatively

• Bone gain

  9 months postoperatively

• Bone loss

  9 months postoperatively

Study Arms (2)

Test group

EXPERIMENTAL

Test subjects receive GTR and early initiation of OTM.

Procedure: Guided tissue regeneration (GTR); Device: Orthodontic tooth movement (OTM)

Control group

ACTIVE COMPARATOR

Control subjects receive only GTR.

Procedure: Guided tissue regeneration (GTR)

Interventions

Guided tissue regeneration (GTR) PROCEDURE

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.

Also known as: Regenerative surgery of an intrabony periodontal defect

Control group; Test group

Orthodontic tooth movement (OTM) DEVICE

An early initialization of the tooth movement with the help of a multibond fixed orthodontic device utilizing low level of continuous orthodontic forces.

Also known as: Multibond fixed orthodontic appliance

Test group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Semmelweis University: lead
• Schupbach Ltd.: collaborator
• Geistlich Pharma AG: collaborator

Study Sites (1)

Semmelweis University Department of Periodontology

Budapest, 1088, Hungary

Location

Related 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.

  PMID: 11142670 BACKGROUND

• 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.

  PMID: 18315442 BACKGROUND

• 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.

  PMID: 14971256 BACKGROUND

• 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.

  PMID: 19194672 BACKGROUND

• 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.

  PMID: 17243328 BACKGROUND

MeSH Terms

Interventions

Guided Tissue Regeneration; Tooth Movement Techniques

Intervention Hierarchy (Ancestors)

Plastic Surgery Procedures; Surgical Procedures, Operative; Orthodontics, Corrective; Orthodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The histologist is blinded to the study protocol
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Patients undergo GTR procedure, after they are randomly allocated either to test (with OTM) or control group (without OTM)

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 21, 2021
• Study Start: September 1, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)