Surgical Treatment of Gingival Recessions

NCT04611282 | Completed

• 1 other identifier: Mamtograrct
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Percentage of root coverage

  The primary endpoint for efficacy of the gingival recession was the percentage of root coverage at baseline and 6-months postsurgery, as measured by gingival recession depth.

  6 months

Secondary Outcomes (4)

• Changes in Gingival recession depth

  6 months

• Changes in Gingival recession width

  6 months

• Changes in Keratinized gingival width

  6 months

• visual analog scale

  6 months

Study Arms (2)

Microsurgery group

EXPERIMENTAL

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

Procedure: surgical techniques in the treatment of localized gingival recession defects.

Macrosurgery group

ACTIVE COMPARATOR

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

Procedure: surgical techniques in the treatment of localized gingival recession defects.

Interventions

surgical techniques in the treatment of localized gingival recession defects. PROCEDURE

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

Macrosurgery group; Microsurgery 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:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead
• Kocaeli University: collaborator

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Periodontology specialist

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: November 2, 2020
• Study Start: December 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share