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Surgical Treatment of Gingival Recessions

Sponsor
Istanbul Medipol University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04611282
Collaborator
Kocaeli University (Other)
17
Enrollment
2
Arms
12
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: surgical techniques in the treatment of localized gingival recession defects.
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Micro and Macrosurgical Treatment of Gingival Recessions: a Randomized Clinical Trial
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
May 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Microsurgery group

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.
Micro or macrosurgical echniques were performed using a coronally positioned flap with a subepithelial connective tissue graft.
Active Comparator: Macrosurgery group

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

Outcome Measures

Primary Outcome Measures

  1. Percentage of root coverage [6 months]

    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.

Secondary Outcome Measures

  1. Changes in Gingival recession depth [6 months]

  2. Changes in Gingival recession width [6 months]

  3. Changes in Keratinized gingival width [6 months]

  4. visual analog scale [6 months]

    A visual analog scale was used to evaluate postoperative complaints regarding the recipient and donor sites according to graft size and postoperative satisfaction values (level of the gingival margin, gingival tissue color, dentin hypersensitivity, and root coverage) during the follow-up period. A 10 cm VAS, with "none" / "unhappy" at the left end and "unbearable" / "happy" at the right end was prepared for each patient.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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:
Exclusion criteria included the following:

  • 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Istanbul Medipol University Hospital
  • Kocaeli University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier:
NCT04611282
Other Study ID Numbers:
  • Mamtograrct
First Posted:
Nov 2, 2020
Last Update Posted:
Nov 2, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Gingival Recession

Study Results

No Results Posted as of Nov 2, 2020