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Two Different Graft Harvesting Techniques Applied in Localized Gingival Recessions

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ClinicalTrials.gov Identifier: NCT05923294
Recruitment Status : Recruiting
First Posted : June 28, 2023
Last Update Posted : October 4, 2023
Sponsor:
Information provided by (Responsible Party):
Ezgi Gürbüz, Kutahya Health Sciences University

Study Description
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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
Gingival Recession, Localized Sensitivity, Tooth Attachment Loss, Periodontal Procedure: Coronally advanced flap with connective tissue graft Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : August 10, 2023
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : July 3, 2024
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Root coverage percentage [ Time Frame: Postoperative 6th month ]
    The comparison of the postoperative recession depth to the initial recession depth

  2. Gingival thickness [ Time Frame: 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 [ Time Frame: Preoperative and postoperative 6th month ]
    Recession width measured at the cemento-enamel junction

  2. Probing depth [ Time Frame: Preoperative and postoperative 6th month ]
    Probing depth measured at the mid-buccal of the recession defect

  3. Clinical attachment loss [ Time Frame: Preoperative and postoperative 6th month ]
    Clinical attachment loss measured at the mid-buccal of the recession defect

  4. Keratinized gingiva width [ Time Frame: Preoperative and postoperative 6th month ]
    Mid-buccal gingival width measured with a periodontal probe

  5. Vestibular depth [ Time Frame: Preoperative and postoperative 6th month ]
    The distance from the gingival margin to the greatest concavity of the mucosal fold

  6. Pain perception [ Time Frame: 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 [ Time Frame: Postoperative 1st week ]
    Bleeding evaluated by a dichotomous index


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05923294


Contacts
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Contact: Ezgi Gürbüz, DDS PhD +905557411860 ezgi.dogan@ksbu.edu.tr

Locations
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Turkey
Kutahya Health Sciences University Recruiting
Kutahya, Turkey, 43020
Contact: Ezgi Gürbüz, DDS PhD    +905557411860    ezgi.dogan@ksbu.edu.tr   
Sponsors and Collaborators
Kutahya Health Sciences University
More Information
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Publications:

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Responsible Party: Ezgi Gürbüz, Assistant professor, Kutahya Health Sciences University
ClinicalTrials.gov Identifier: NCT05923294    
Other Study ID Numbers: 0043
First Posted: June 28, 2023    Key Record Dates
Last Update Posted: October 4, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gingival Recession
Dentin Sensitivity
Periodontal Attachment Loss
Gingival Diseases
Periodontal Diseases
 Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy
Tooth Diseases