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Two Different Graft Harvesting Techniques Applied in Localized Gingival Recessions

Primary Purpose

Gingival Recession, Localized, Sensitivity, Tooth, Attachment Loss, Periodontal

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Coronally advanced flap with connective tissue graft
Sponsored by
Kutahya Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession, Localized

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: American Society of Anesthesiologists physical status class 1 and 2 patients,healthy patients Nonsmokers Periodontally healthy patients Localized gingival recessions (Miller I, II, and Cairo I recessions with a depth of recession of at least 2 mm) in anterior and premolar teeth Exclusion Criteria: Medically compromised patients, especially uncontrolled diabetes Pregnancy, lactation, or suspicion of pregnancy, Poor oral hygiene Recessions associated with caries or restoration

Sites / Locations

  • Kutahya Health Sciences UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

De-epithelialized gingival unit graft

De-epithelialized free gingival graft

Arm Description

In this split-mouth randomized controlled trial, the coin toss method will determine test and control groups. In both groups, connective tissue graft with a trapezoidal flap design will be applied to the recession area. To obtain the connective tissue graft, the gingival unit graft will be de-epithelialized in the test group.

In this split-mouth randomized controlled trial, the coin toss method will determine test and control groups. In both groups, connective tissue graft with a trapezoidal flap design will be applied to the recession area. To obtain the connective tissue graft, the traditional free gingival graft will be de-epithelialized in the control group.

Outcomes

Primary Outcome Measures

Root coverage percentage
The comparison of the postoperative recession depth to the initial recession depth
Gingival thickness
Gingival thickness in the mid-buccal of the recession defect measured with an endodontic spreader and digital recordings

Secondary Outcome Measures

Recession width
Recession width measured at the cemento-enamel junction
Probing depth
Probing depth measured at the mid-buccal of the recession defect
Clinical attachment loss
Clinical attachment loss measured at the mid-buccal of the recession defect
Keratinized gingiva width
Mid-buccal gingival width measured with a periodontal probe
Vestibular depth
The distance from the gingival margin to the greatest concavity of the mucosal fold
Pain perception
Visual analog scale where higher scores mean a worse outcome and has a minimum value of 0 and a maximum value of 10
Bleeding related to the procedure
Bleeding evaluated by a dichotomous index

Full Information

First Posted
June 20, 2023
Last Updated
October 2, 2023
Sponsor
Kutahya Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT05923294
Brief Title
Two Different Graft Harvesting Techniques Applied in Localized Gingival Recessions
Official Title
Clinical Comparison of Two Different Graft Harvesting Techniques Applied in Localized Gingival Recessions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
July 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences 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 primary purpose of this study is to compare the root coverage rate of the gingival unit-shaped connective tissue graft, obtained by intraoral de-epithelization, with the traditional de-epithelialized free gingival graft in localized recessions of anterior and premolar teeth. In addition, it is aimed to compare the postoperative gingival thickness between the two techniques. The secondary aim is to search the effects of both techniques on periodontal parameters and to evaluate patient-centered outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Localized, Sensitivity, Tooth, Attachment Loss, Periodontal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
De-epithelialized gingival unit graft
Arm Type
Experimental
Arm Description
In this split-mouth randomized controlled trial, the coin toss method will determine test and control groups. In both groups, connective tissue graft with a trapezoidal flap design will be applied to the recession area. To obtain the connective tissue graft, the gingival unit graft will be de-epithelialized in the test group.
Arm Title
De-epithelialized free gingival graft
Arm Type
Experimental
Arm Description
In this split-mouth randomized controlled trial, the coin toss method will determine test and control groups. In both groups, connective tissue graft with a trapezoidal flap design will be applied to the recession area. To obtain the connective tissue graft, the traditional free gingival graft will be de-epithelialized in the control group.
Intervention Type
Procedure
Intervention Name(s)
Coronally advanced flap with connective tissue graft
Intervention Description
In both groups, connective tissue graft with a trapezoidal flap design will be applied to the recession area.
Primary Outcome Measure Information:
Title
Root coverage percentage
Description
The comparison of the postoperative recession depth to the initial recession depth
Time Frame
Postoperative 6th month
Title
Gingival thickness
Description
Gingival thickness in the mid-buccal of the recession defect measured with an endodontic spreader and digital recordings
Time Frame
Preoperative and postoperative 6th month
Secondary Outcome Measure Information:
Title
Recession width
Description
Recession width measured at the cemento-enamel junction
Time Frame
Preoperative and postoperative 6th month
Title
Probing depth
Description
Probing depth measured at the mid-buccal of the recession defect
Time Frame
Preoperative and postoperative 6th month
Title
Clinical attachment loss
Description
Clinical attachment loss measured at the mid-buccal of the recession defect
Time Frame
Preoperative and postoperative 6th month
Title
Keratinized gingiva width
Description
Mid-buccal gingival width measured with a periodontal probe
Time Frame
Preoperative and postoperative 6th month
Title
Vestibular depth
Description
The distance from the gingival margin to the greatest concavity of the mucosal fold
Time Frame
Preoperative and postoperative 6th month
Title
Pain perception
Description
Visual analog scale where higher scores mean a worse outcome and has a minimum value of 0 and a maximum value of 10
Time Frame
Postoperative 1st week
Title
Bleeding related to the procedure
Description
Bleeding evaluated by a dichotomous index
Time Frame
Postoperative 1st week

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: American Society of Anesthesiologists physical status class 1 and 2 patients,healthy patients Nonsmokers Periodontally healthy patients Localized gingival recessions (Miller I, II, and Cairo I recessions with a depth of recession of at least 2 mm) in anterior and premolar teeth Exclusion Criteria: Medically compromised patients, especially uncontrolled diabetes Pregnancy, lactation, or suspicion of pregnancy, Poor oral hygiene Recessions associated with caries or restoration
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ezgi Gürbüz, DDS PhD
Phone
+905557411860
Email
ezgi.dogan@ksbu.edu.tr
Facility Information:
Facility Name
Kutahya Health Sciences University
City
Kutahya
ZIP/Postal Code
43020
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ezgi Gürbüz, DDS PhD
Phone
+905557411860
Email
ezgi.dogan@ksbu.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12636127
Citation
Kassab MM, Cohen RE. The etiology and prevalence of gingival recession. J Am Dent Assoc. 2003 Feb;134(2):220-5. doi: 10.14219/jada.archive.2003.0137.
Results Reference
background
PubMed Identifier
26941519
Citation
Mythri S, Arunkumar SM, Hegde S, Rajesh SK, Munaz M, Ashwin D. Etiology and occurrence of gingival recession - An epidemiological study. J Indian Soc Periodontol. 2015 Nov-Dec;19(6):671-5. doi: 10.4103/0972-124X.156881.
Results Reference
background
PubMed Identifier
20103476
Citation
Kassab MM, Badawi H, Dentino AR. Treatment of gingival recession. Dent Clin North Am. 2010 Jan;54(1):129-40. doi: 10.1016/j.cden.2009.08.009.
Results Reference
background
PubMed Identifier
27454460
Citation
Cairo F, Pagliaro U, Buti J, Baccini M, Graziani F, Tonelli P, Pagavino G, Tonetti MS. Root coverage procedures improve patient aesthetics. A systematic review and Bayesian network meta-analysis. J Clin Periodontol. 2016 Nov;43(11):965-975. doi: 10.1111/jcpe.12603. Epub 2016 Sep 16.
Results Reference
background
PubMed Identifier
31177536
Citation
Zucchelli G, Tavelli L, Barootchi S, Stefanini M, Rasperini G, Valles C, Nart J, Wang HL. The influence of tooth location on the outcomes of multiple adjacent gingival recessions treated with coronally advanced flap: A multicenter re-analysis study. J Periodontol. 2019 Nov;90(11):1244-1251. doi: 10.1002/JPER.18-0732. Epub 2019 Jul 1.
Results Reference
background
PubMed Identifier
15119887
Citation
Allen AL. Use of the gingival unit transfer in soft tissue grafting: report of three cases. Int J Periodontics Restorative Dent. 2004 Apr;24(2):165-75.
Results Reference
background
PubMed Identifier
22390550
Citation
Kuru B, Yildirim S. Treatment of localized gingival recessions using gingival unit grafts: a randomized controlled clinical trial. J Periodontol. 2013 Jan;84(1):41-50. doi: 10.1902/jop.2012.110685. Epub 2012 Mar 5.
Results Reference
background
PubMed Identifier
32233187
Citation
Sriwil M, Fakher MAA, Hasan K, Kasem T, Shwaiki T, Wassouf G. Comparison of Free Gingival Graft and Gingival Unit Graft for Treatment of Gingival Recession: A Randomized Controlled Trial. Int J Periodontics Restorative Dent. 2020 May/Jun;40(3):e103-e110. doi: 10.11607/prd.4180.
Results Reference
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Two Different Graft Harvesting Techniques Applied in Localized Gingival Recessions

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