Surgical Treatment of Gingival Recessions
Primary Purpose
Clinical Trial, Connective Tissue, Gingival Recession
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
surgical techniques in the treatment of localized gingival recession defects.
Sponsored by
About this trial
This is an interventional treatment trial for Clinical Trial
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:
-
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Microsurgery group
Macrosurgery group
Arm Description
All defects were treated with a CPF plus an SCTG by the same investigator using microsurgery technique.
All defects were treated with a CPF plus an SCTG by the same investigator using macrosurgery technique.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes in Gingival recession depth
Changes in Gingival recession width
Changes in Keratinized gingival width
visual analog scale
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.
Full Information
NCT ID
NCT04611282
First Posted
October 12, 2020
Last Updated
September 26, 2023
Sponsor
Istanbul Medipol University Hospital
Collaborators
Kirsehir Ahi Evran University
1. Study Identification
Unique Protocol Identification Number
NCT04611282
Brief Title
Surgical Treatment of Gingival Recessions
Official Title
Micro and Macrosurgical Treatment of Gingival Recessions: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital
Collaborators
Kirsehir Ahi Evran University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical Trial, Connective Tissue, Gingival Recession, Microsurgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Microsurgery group
Arm Type
Experimental
Arm Description
All defects were treated with a CPF plus an SCTG by the same investigator using microsurgery technique.
Arm Title
Macrosurgery group
Arm Type
Active Comparator
Arm Description
All defects were treated with a CPF plus an SCTG by the same investigator using macrosurgery technique.
Intervention Type
Procedure
Intervention Name(s)
surgical techniques in the treatment of localized gingival recession defects.
Intervention Description
Micro or macrosurgical echniques were performed using a coronally positioned flap with a subepithelial connective tissue graft.
Primary Outcome Measure Information:
Title
Percentage of root coverage
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in Gingival recession depth
Time Frame
6 months
Title
Changes in Gingival recession width
Time Frame
6 months
Title
Changes in Keratinized gingival width
Time Frame
6 months
Title
visual analog scale
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
-
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Surgical Treatment of Gingival Recessions
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