Two Different Graft Harvesting Techniques Applied in Localized Gingival Recessions

Sponsor
Kutahya Health Sciences University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05923294
Collaborator
(none)
12
1
2
12
1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Coronally advanced flap with connective tissue graft
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Comparison of Two Different Graft Harvesting Techniques Applied in Localized Gingival Recessions
Anticipated Study Start Date :
Jul 3, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: De-epithelialized gingival unit graft

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.

Procedure: Coronally advanced flap with connective tissue graft
In both groups, connective tissue graft with a trapezoidal flap design will be applied to the recession area.

Experimental: De-epithelialized free gingival graft

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.

Procedure: Coronally advanced flap with connective tissue graft
In both groups, connective tissue graft with a trapezoidal flap design will be applied to the recession area.

Outcome Measures

Primary Outcome Measures

  1. Root coverage percentage [Postoperative 6th month]

    The comparison of the postoperative recession depth to the initial recession depth

  2. Gingival thickness [Preoperative and postoperative 6th month]

    Gingival thickness in the mid-buccal of the recession defect measured with an endodontic spreader and digital recordings

Secondary Outcome Measures

  1. Recession width [Preoperative and postoperative 6th month]

    Recession width measured at the cemento-enamel junction

  2. Probing depth [Preoperative and postoperative 6th month]

    Probing depth measured at the mid-buccal of the recession defect

  3. Clinical attachment loss [Preoperative and postoperative 6th month]

    Clinical attachment loss measured at the mid-buccal of the recession defect

  4. Keratinized gingiva width [Preoperative and postoperative 6th month]

    Mid-buccal gingival width measured with a periodontal probe

  5. Vestibular depth [Preoperative and postoperative 6th month]

    The distance from the gingival margin to the greatest concavity of the mucosal fold

  6. Pain perception [Postoperative 1st week]

    Visual analog scale where higher scores mean a worse outcome and has a minimum value of 0 and a maximum value of 10

  7. Bleeding related to the procedure [Postoperative 1st week]

    Bleeding evaluated by a dichotomous index

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. American Society of Anesthesiologists physical status class 1 and 2 patients,healthy patients

  2. Nonsmokers

  3. Periodontally healthy patients

  4. 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:
  1. Medically compromised patients, especially uncontrolled diabetes

  2. Pregnancy, lactation, or suspicion of pregnancy,

  3. Poor oral hygiene

  4. Recessions associated with caries or restoration

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kutahya Health Sciences University Kutahya Turkey 43020

Sponsors and Collaborators

  • Kutahya Health Sciences University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ezgi Gürbüz, Assistant professor, Kutahya Health Sciences University
ClinicalTrials.gov Identifier:
NCT05923294
Other Study ID Numbers:
  • 0043
First Posted:
Jun 28, 2023
Last Update Posted:
Jul 6, 2023
Last Verified:
Jul 1, 2023
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:

Study Results

No Results Posted as of Jul 6, 2023