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Completed

NCT Number: NCT07064304

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dentoplex

Bielsko-Biala, 43-300, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  2. Change in Keratinized Tissue Width

    Time frame: Baseline, 3 months, and 6 months postoperatively

    Measurement of the width of keratinized gingiva in millimeters from the mucogingival junction to the free gingival margin.

    Unit of Measure: mm

  3. Change in Gingival Thickness

    Time frame: Baseline, 3 months, and 6 months postoperatively

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

  4. Change in Pocket Depth

    Time frame: Baseline, 3 months, and 6 months postoperatively

    Probing depth measured from the gingival margin to the base of the periodontal pocket.

    Unit of Measure: mm

  5. Change in Clinical Attachment Level

    Time frame: Baseline, 3 months, and 6 months postoperatively

    Measurement of the distance from the cementoenamel junction to the base of the periodontal pocket.

    Unit of Measure: mm

  6. Change in Pink Esthetic Score

    Time frame: Baseline, 3 months, and 6 months postoperatively

    Percentage of interdental spaces with visible plaque, calculated to assess oral hygiene status. A lower percentage indicates better plaque control.

    Unit of Measure: percentage (%)

  7. Mean Root Coverage

    Time frame: 6 months postoperatively

    Average percentage of root surface covered by soft tissue following treatment, calculated across all treated sites.

    Unit of Measure: percentage (%)

  8. Complete Root Coverage

    Time frame: 6 months postoperatively

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

Secondary outcomes

  1. Histopathological Evaluation of Laser-Treated Connective Tissue Grafts

    Time frame: Immediately postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Official study title

Clinical Efficacy of Er,Cr:YSGG Laser for Deepithelialization of Free Gingival Grafts in Gingival Recession Treatment: A Randomized, Split-Mouth Clinical Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 14, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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