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

NCT ID: NCT07064304

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gingival Recession, Localized Keratinized Tissue Gingival Thickness Pocket Depth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Laser Deepithelialization of Free Gingival Graft

Intervention Type 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 (DEE)

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

Group Type ACTIVE_COMPARATOR

Scalpel Deepithelialization of Free Gingival Graft

Intervention Type PROCEDURE

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

Interventions

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Laser Deepithelialization of Free Gingival Graft

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.

Intervention Type PROCEDURE

Scalpel Deepithelialization of Free Gingival Graft

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

Intervention Type PROCEDURE

Eligibility Criteria

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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%)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wroclaw Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dentoplex

Bielsko-Biala, , Poland

Site Status

Countries

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Poland

Other Identifiers

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WroclawMU6

Identifier Type: -

Identifier Source: org_study_id

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