Er,Cr:YSGG Laser for Deepithelialization in Gingival Recession.

NCT07064304 | Completed

• 1 other identifier: WroclawMU6
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Abstract: Introduction: The deepithelialized free gingival graft (DGG) technique provides high-quality connective tissue grafts (CTGs) with predictable outcomes for recession cov-erage. This study evaluates a novel method of free gingival graft (FGG) deepithelialization using an Er,Cr:YSGG laser (LDEE) for treating multiple gingival recessions. Methods: A split-mouth study was conducted on 46 (n=46) recessions in 9 patients (23 per test and control group). Sites were randomized. Full-thickness palatal grafts were harvested with a scalpel. In the test group (LDEE), deepithelialization was performed extraorally using an Er,Cr:YSGG laser (2780 nm; 2.5 W, 83.3 mJ, 30 Hz, 600 µm tip). In the control group (DEE), a 15c scalpel was used. All CTGs were applied using the modified coronally advanced tunnel (TUN) technique. Clinical parameters-recession depth (RD), keratinized tissue width (KT), gingival thickness (GT), pocket depth (PD), clinical attachment loss (CAL), pink esthetic score (PES), approximal plaque index (API), mean root coverage (MRC), and complete root coverage (CRC)-were assessed at baseline (T0), 3 months (T1), and 6 months (T2). Results: Both LDEE and DEE groups showed significant improvements in RD, KT, GT, PD, and CAL over time (p \< 0.001). At T1 and T2, KT was significantly higher in the LDEE group (T1: 3.73±0.72 mm; T2: 3.98±0.76 mm) compared to the DEE group (T1: 3.21±0.61 mm; T2: 3.44±0.74 mm; p \< 0.05). Other parameters (RD, GT, PD, CAL) showed no statistically significant intergroup differences at any time point (p \> 0.05). After 6 months, MRC was 95% and CRC 82.6% for LDEE, compared to 94.8% and 82.6% for DEE (p \> 0.05). PES scores were similar between groups at all time points (p \> 0.05). Conclusion: Both laser- and scalpel-deepithelialized grafts effectively treated gingival recessions. LDEE combined with TUN resulted in significantly greater KT width compared to DEE + TUN.

Conditions

Gingival Recession, Localized; Keratinized Tissue; Gingival Thickness; Pocket Depth

Outcome Measures

Primary Outcomes (8)

• Change in Recession Depth

  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

• Change in Keratinized Tissue Width

  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

• Change in Gingival Thickness

  Assessment of gingival tissue thickness using a standardized probe. Unit of Measure: mm

  Baseline, 3 months, and 6 months postoperatively

• Change in Pocket Depth

  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

• Change in Clinical Attachment Level

  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

• Change in Pink Esthetic Score

  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

• Mean Root Coverage

  Average percentage of root surface covered by soft tissue following treatment, calculated across all treated sites. Unit of Measure: percentage (%)

  6 months postoperatively

• Complete Root Coverage

  Proportion of treated sites that achieved 100% root coverage postoperatively. Unit of Measure: percentage (%)

  6 months postoperatively

Secondary Outcomes (1)

• Histopathological Evaluation of Laser-Treated Connective Tissue Grafts

  Immediately postoperatively

Study Arms (2)

Laser Deepithelialization (LDEE)

EXPERIMENTAL

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.

Procedure: Laser Deepithelialization of Free Gingival Graft

Scalpel Deepithelialization (DEE)

ACTIVE COMPARATOR

In this arm, the epithelium was removed manually using a 15c surgical scalpel from the harvested palatal free gingival graft before placement.

Procedure: Scalpel Deepithelialization of Free Gingival Graft

Interventions

Laser Deepithelialization of Free Gingival Graft PROCEDURE

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.

Laser Deepithelialization (LDEE)

Scalpel Deepithelialization of Free Gingival Graft PROCEDURE

Extraoral deepithelialization of harvested free gingival graft using a 15c surgical scalpel blade before placement in gingival recession treatment.

Scalpel Deepithelialization (DEE)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Dentoplex

Bielsko-Biala, 43-300, Poland

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 14, 2025
• Study Start: February 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: July 14, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)