- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07064304
- Original Trial
Er,Cr:YSGG Laser for Deepithelialization in Gingival Recession.
Clinical Efficacy of Er,Cr:YSGG Laser for Deepithelialization of Free Gingival Grafts in Gingival Recession Treatment: A Randomized, Split-Mouth Clinical Trial
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Bielsko-Biala, Poland, 43-300
- Dentoplex
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 70 years
- Presence of multiple Miller Class I or II gingival recessions
- Good general and oral health
- Patient consent to participate in the clinical trial
- Availability for follow-up at 3 and 6 months
Exclusion Criteria:
- Smoking or history of smoking in the last 6 months
- Systemic diseases affecting wound healing (e.g., diabetes, immunodeficiencies)
- Pregnancy or lactation
- Use of medications that influence periodontal tissues (e.g., immunosuppressants, corticosteroids)
- History of periodontal surgery in the area of interest within the past 12 months Inadequate oral hygiene (plaque index >20%)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Laser Deepithelialization (LDEE)
In this arm, deepithelialization of the free gingival graft was performed extraorally using an Er,Cr:YSGG laser (2780 nm; 2.5 W; 83.3 mJ; 30 Hz; 600 μm tip) before graft placement at the recipient site.
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Extraoral deepithelialization of harvested free gingival graft using Er,Cr:YSGG laser (2780 nm, 2.5 W, 83.3 mJ, 30 Hz, 600 μm tip) before placement in gingival recession treatment.
|
|
Active Comparator: Scalpel Deepithelialization (DEE)
In this arm, the epithelium was removed manually using a 15c surgical scalpel from the harvested palatal free gingival graft before placement.
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Extraoral deepithelialization of harvested free gingival graft using a 15c surgical scalpel blade before placement in gingival recession treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Recession Depth
Time Frame: Baseline, 3 months, and 6 months postoperatively
|
Measurement of gingival recession depth in millimeters to evaluate soft tissue response to treatment. Unit of Measure: mm |
Baseline, 3 months, and 6 months postoperatively
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Change in Keratinized Tissue Width
Time Frame: Baseline, 3 months, and 6 months postoperatively
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Measurement of the width of keratinized gingiva in millimeters from the mucogingival junction to the free gingival margin. Unit of Measure: mm |
Baseline, 3 months, and 6 months postoperatively
|
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Change in Gingival Thickness
Time Frame: Baseline, 3 months, and 6 months postoperatively
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Assessment of gingival tissue thickness using a standardized probe.
Unit of Measure: mm
|
Baseline, 3 months, and 6 months postoperatively
|
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Change in Pocket Depth
Time Frame: Baseline, 3 months, and 6 months postoperatively
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Probing depth measured from the gingival margin to the base of the periodontal pocket. Unit of Measure: mm |
Baseline, 3 months, and 6 months postoperatively
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Change in Clinical Attachment Level
Time Frame: Baseline, 3 months, and 6 months postoperatively
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Measurement of the distance from the cementoenamel junction to the base of the periodontal pocket. Unit of Measure: mm |
Baseline, 3 months, and 6 months postoperatively
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Change in Pink Esthetic Score
Time Frame: Baseline, 3 months, and 6 months postoperatively
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Percentage of interdental spaces with visible plaque, calculated to assess oral hygiene status. A lower percentage indicates better plaque control. Unit of Measure: percentage (%) |
Baseline, 3 months, and 6 months postoperatively
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Mean Root Coverage
Time Frame: 6 months postoperatively
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Average percentage of root surface covered by soft tissue following treatment, calculated across all treated sites. Unit of Measure: percentage (%) |
6 months postoperatively
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Complete Root Coverage
Time Frame: 6 months postoperatively
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Proportion of treated sites that achieved 100% root coverage postoperatively.
Unit of Measure: percentage (%)
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6 months postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Histopathological Evaluation of Laser-Treated Connective Tissue Grafts
Time Frame: Immediately postoperatively
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Microscopic assessment of grafts treated with Er,Cr:YSGG laser to evaluate the quality of deepithelialization and potential thermal damage.
Parameters included the presence of a clear boundary between epithelium and connective tissue, absence of carbonization or necrosis, and preservation of tissue architecture.
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Immediately postoperatively
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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
- WroclawMU6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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