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

July 10, 2025 updated by: Wroclaw Medical University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bielsko-Biala, Poland, 43-300
        • Dentoplex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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
Baseline, 3 months, and 6 months postoperatively
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
Baseline, 3 months, and 6 months postoperatively
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
Baseline, 3 months, and 6 months postoperatively
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
Baseline, 3 months, and 6 months postoperatively
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 (%)
Baseline, 3 months, and 6 months postoperatively
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 (%)
6 months postoperatively
Complete Root Coverage
Time Frame: 6 months postoperatively
Proportion of treated sites that achieved 100% root coverage postoperatively. Unit of Measure: percentage (%)
6 months postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Immediately postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wroclaw Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WroclawMU6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Although this was a prospective clinical study, we do not plan to share individual participant data (IPD) due to lack of consent for data sharing obtained at the time of enrollment.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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