Surgical Treatment of Gingival Recessions

NCT ID: NCT04611282

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-12-31

Brief Summary

The purpose of this study was to compare the effectiveness of microsurgical and macrosurgical approaches on CPFs plus SCTGs for the treatment of localized gingival recession defects (Miller class I or II) over the course of 6 months based on clinical periodontal parameters, periodontal phenotypes, and the postoperative complaints and satisfaction levels of the patients. We hypothesized that root coverage achieved through microsurgery in Miller I or II gingival recessions would improve clinical periodontal outcomes and the periodontal phenotype, with greater postoperative comfort and aesthetic satisfaction in comparison with conventional macrosurgical techniques. Miller Class I and II gingival recession defects, at least 3.0 mm deep, were selected and randomly assigned to receive micro or macrosurgical techniques. Both techniques were performed using a coronally positioned flap with a subepithelial connective tissue graft. Plaque and gingival indices, gingival recession depth and width, probing pocket depth, bleeding on probing, clinical attachment level, width of keratinized gingiva, aesthetic score and percentage of root coverage, postoperative complaints, and satisfaction of the participants completing the study were evaluated at follow-up 1st, 3rd and 6th months.

Conditions

Clinical Trial; Connective Tissue; Gingival Recession; Microsurgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Microsurgery group

All defects were treated with a CPF plus an SCTG by the same investigator using microsurgery technique.

Group Type: EXPERIMENTAL

surgical techniques in the treatment of localized gingival recession defects.

Intervention Type: PROCEDURE

Micro or macrosurgical echniques were performed using a coronally positioned flap with a subepithelial connective tissue graft.

Macrosurgery group

All defects were treated with a CPF plus an SCTG by the same investigator using macrosurgery technique.

Group Type: ACTIVE_COMPARATOR

surgical techniques in the treatment of localized gingival recession defects.

Intervention Type: PROCEDURE

Micro or macrosurgical echniques were performed using a coronally positioned flap with a subepithelial connective tissue graft.

Interventions

surgical techniques in the treatment of localized gingival recession defects.

Micro or macrosurgical echniques were performed using a coronally positioned flap with a subepithelial connective tissue graft.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

-

All participants were:

• adults aged 18 years or over
• systemically and periodontally healthy
• met the eligibility criteria for localized gingival recession of the canine or premolar teeth according to the Miller classification scheme

Exclusion Criteria

-

• medical disorders such as diabetes mellitus, immunologic disorders, and hepatitis;
• a history of chemotherapy or radiotherapy;
• a history of alcoholism or drug abuse;
• a history of previous mucogingival surgery at the gingival recession site;
• medications known to affect gingival tissues;
• antibiotic treatment in the past 6 months;
• smoking >10 cigarettes per day for >5 years, and;
• current pregnancy or lactation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kocaeli University

OTHER

Sponsor Role: collaborator

Istanbul Medipol University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Begum Alkan

Periodontology specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Mamtograrct

Identifier Type: -

Identifier Source: org_study_id