- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07706257
Clinical Outcomes and Digital Color Stability of Gingival Unit Graft vs. Free Gingival Graft: An 18-Month Comparative Spectrophotometric Study
Aesthetic Integration of Gingival Unit Graft Compared to Conventional Free Gingival Graft: A Comparative 18-Month Spectrophotometric Color Evaluation in Keratinized Tissue Gain
Study Overview
Status
Intervention / Treatment
Detailed Description
This single-center, retrospective study involves a comparative analysis of patients who underwent periodontal surgery for keratinized tissue gain using either Gingival Unit Grafts (GUG) or Conventional Free Gingival Grafts (FGG) between March 2022 and December 2022.
Clinical examinations, digital documentation, and spectrophotometric color measurements were tracked at baseline and during regular follow-ups up to 18 months post-surgery. The primary focus of the evaluation is the objective assessment of aesthetic integration (color harmony, tissue texture, and blending) using spectrophotometric data (CIE L*a*b* color space parameters) alongside standard clinical periodontal parameters. The findings aim to determine which grafting technique provides superior color match and long-term aesthetic stability in the recipient area.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Fatih
-
Istanbul, Fatih, Turkey (Türkiye), 34093
- Bezmialem Vakif University, Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Systemically healthy individuals aged between 18 and 65 years. No systemic diseases contraindicating periodontal surgery. Not taking medications known to exert adverse effects on periodontal tissues. Presenting with Cairo Type 2 (RT2) or Type 3 (RT3) localized gingival recessions on mandibular incisors.
Inability to maintain effective plaque control due to a width of attached gingiva ≤ 1 mm.
Full-mouth plaque and gingival index scores ≤ 1. A bleeding on probing (BOP) score less than 10%. No history of prior soft tissue surgery in the designated area.
Exclusion Criteria:
Individuals who are pregnant or lactating. Presenting with gingival recession or prosthetic restorations at the donor site (maxillary premolar palatal region).
Cases demonstrating caries, abrasions, or restorations on the root surfaces of the related teeth.
Individuals with known allergies to dental impression materials. Periodontal pocket depth greater than 3 mm. Tooth malposition. Endodontic complications.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Gingival Unit Graft (GUG) Group
Patients who underwent periodontal plastic surgery using Gingival Unit Grafts for keratinized tissue gain
|
Harvesting a gingival unit graft and transplanting it to the recipient area to increase keratinized tissue width and assess long-term aesthetic integration.
|
|
Conventional Free Gingival Graft (FGG) Group
Patients who underwent periodontal plastic surgery using Conventional Free Gingival Grafts for keratinized tissue gain
|
Harvesting a conventional free gingival graft and transplanting it to the recipient area to increase keratinized tissue width and serve as a control group for aesthetic integration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aesthetic Integration (Color Evaluation)
Time Frame: Baseline and 18 months post-surgery
|
The objective assessment of the color match and structural blending between the grafted tissues and the surrounding native gingiva.
Color parameters are evaluated based on the CIE L*a*b* color space system using spectrophotometric measurements to determine the overall aesthetic harmony (Delta E) over the follow-up period.
|
Baseline and 18 months post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Keratinized Tissue Width (KTW)
Time Frame: Baseline and 18 months post-surgery
|
The clinical measurement of the width of keratinized tissue in millimeters, evaluated from the gingival margin to the mucogingival junction using a standard periodontal probe to determine the amount of tissue gain.
|
Baseline and 18 months post-surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- No: 2024/304
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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