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

NCT04896450 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-02-21

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Schupbach Ltd.

    collaborator UNKNOWN

  • Geistlich Pharma AG

    collaborator INDUSTRY

  • Semmelweis University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04896450 on ClinicalTrials.gov