Gingival Recession, LocalizedNCT07064304
Er,Cr:YSGG Laser for Deepithelialization in Gingival Recession.
A study testing Laser Deepithelialization of Free Gingival Graft and Scalpel Deepithelialization of Free Gingival Graft in people with Gingival Recession, Localized and Keratinized Tissue, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
Abstract: Introduction: The deepithelialized free gingival graft (DGG) technique provides high-quality connective tissue grafts (CTGs) with predictable outcomes for recession cov-erage. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gingival Recession, Localized, Keratinized Tissue, Gingival Thickness
- What is being tested?
- Laser Deepithelialization of Free Gingival Graft and Scalpel Deepithelialization of Free Gingival Graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Laser Deepithelialization of Free Gingival Graft, Scalpel Deepithelialization of Free Gingival Graft
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Deepithelialization of Free Gingival GraftProcedure or surgery
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 GraftProcedure or surgery
Extraoral deepithelialization of harvested free gingival graft using a 15c surgical scalpel blade before placement in gingival recession treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Scalpel Deepithelialization of Free Gingival Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Recession Depth
Measurement of gingival recession depth in millimeters to evaluate soft tissue response to treatment.
Unit of Measure: mm
Measured: 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
Measured: Baseline, 3 months, and 6 months postoperatively
Change in Gingival Thickness
Assessment of gingival tissue thickness using a standardized probe. Unit of Measure: mm
Measured: 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
Measured: 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
Measured: 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 (%)
Measured: 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 (%)
Measured: 6 months postoperatively
Complete Root Coverage
Proportion of treated sites that achieved 100% root coverage postoperatively. Unit of Measure: percentage (%)
Measured: 6 months postoperatively
Secondary outcomes (1)
Histopathological Evaluation of Laser-Treated Connective Tissue Grafts
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.
Measured: Immediately postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Feb 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Recession, LocalizedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064304
- Sponsor's protocol ID
- WroclawMU6
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Er,Cr:YSGG Laser for Deepithelialization of Free Gingival Grafts in Gingival Recession Treatment: A Randomized, Split-Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT07064304
- Acronym / sponsor ID
- WroclawMU6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Deepithelialization (LDEE) | Experimental | Procedure: Laser Deepithelialization of Free Gingival GraftIn 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. |
| Scalpel Deepithelialization (DEE) | Active comparator | Procedure: Scalpel Deepithelialization of Free Gingival GraftIn this arm, the epithelium was removed manually using a 15c surgical scalpel from the harvested palatal free gingival graft before placement. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser Deepithelialization of Free Gingival GraftExtraoral 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. | Procedure or surgery | Laser Deepithelialization (LDEE) |
| Scalpel Deepithelialization of Free Gingival GraftExtraoral deepithelialization of harvested free gingival graft using a 15c surgical scalpel blade before placement in gingival recession treatment. | Procedure or surgery | Scalpel Deepithelialization (DEE) |
Primary outcome
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
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
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
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
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
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 (%)
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 (%)
Complete Root Coverage
Time frame: 6 months postoperatively
Proportion of treated sites that achieved 100% root coverage postoperatively. Unit of Measure: percentage (%)
1 secondary outcome
Histopathological Evaluation of Laser-Treated Connective Tissue Grafts
Time frame: Immediately postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Deepithelialization of Free Gingival Graft and Scalpel Deepithelialization of Free Gingival Graft in people with Gingival Recession, Localized and Keratinized Tissue, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Recession Depth (time frame: Baseline, 3 months, and 6 months postoperatively). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.