- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04680806
Laser-Assisted Gingival Depigmentation
Gingival Depigmentation With Er,Cr:YSGG and Diode Laser: Randomized Clinical Trial to Evaluate the Repigmentation and Patient Perceptions
Study Overview
Status
Intervention / Treatment
Detailed Description
This study aim to compare the clinical outcomes, the rate of repigmentation, and the patient perceptions after laser-assisted gingival depigmentation with diode 940 nm and Erbium, chromium-doped yttrium, scandium, gallium and garnet (Er,Cr:YSGG) 2780 nm. Two pigmentation index were used to compare between the treatment outcomes of using Diode laser or Er,Cr:YSGG.
The depigmentation procedure essentially involves ablation of epithelial layer of buccal gingiva containing melanin pigmentation.
Sixty healthy patients (22 males and 38 females, aged 21 to 43 years) who presented with a chief complaint of having dark-brown to black gingival hyperpigmentation between April 2015 and September 2018. Participants were randomly divided into 2 groups (30 patients each). Randomization was carried out using randomization table; by a computer-generated randomization list (SPSS v23.0) with allocation ratio 1:1.
All of the patients were selected according to the study inclusion and exclusion criteria.
Data collection was done by a dental specialist who was blinded about the provided treatment. Data collections included the clinical examination at baseline and follow up appointments. To achieve blinding, three calibrated external experts, blinded to the provided treatment classified the degree of gingival pigments and gingival topography according oral pigmentation index (DOPI) and melanin pigmentation index.
The periodontal surgery was performed by a periodontist specialised in laser dentistry. The periodontist did not interfere with the treatment option.
Descriptive statistics and statistical analysis was done by an external expert using SPSS Statistics software(SPSS v23.0) . Nonparametric tests, Kruskal-Wallis test was used to compare between the two groups according the time intervals.
The patients who did not show in all the study follow up's appointments were dropped from the data analysis.
Patients were asked to evaluate the procedure by using a self-administered questionnaire. The patients were recalled after 1 week, 1 month, 12 months and 24 months.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Doha, Qatar, 13876
- Dr. Tamim Dental Polyclinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• All patient exhibiting physiologic pigmentation of score2 or more according to Oral pigmentation index (DOPI)
Exclusion Criteria:
- Pathologic hyperpigmentation
- Participants with a systemic condition that could affect tissue healing (e. g., autoimmune diseases)
- Pregnancy and lactation
- History of smoking
- Previous mucogingival surgery at the region to be treated
- No contraindication for the laser treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Er,Cr:YSGG laser 2780 nm
Group A was treated by an Er,Cr:YSGG laser 2780 nm cylindrical tip (tip 600 μm, 45 millijoule /pulse, average power 2.25 W, frequency 50 Hz, pulse duration 60 µs, energy density 43 J/cm2, water 50%, and air 40%).
The procedure was performed completely without anesthesia with the laser tip at angulation ~30° and distance of ~1 mm from the gingival tissue.
The laser tip was advancing in scanning movement from in the cervical-apical direction in all pigmented areas.
The following settings was used to achieve hemostasis in case of the bleeding was present (tip 600 μm, 30 millijoule /pulse, average power 1.5 W, frequency 50 Hz, pulse duration 700 µs, energy density 28.7 J/cm2, water 10%, and air 20%).
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The depigmentation procedure essentially involves laser ablation of epithelial layer of buccal gingiva containing melanin pigmentation.
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Experimental: Diode laser 940 nm
Group B was treated with diode 940 nm Laser.
The procedure was performed with a pencil-sized handpiece containing a 400 µm lasing fiber (400 μm initiated tip, average power 0.8 watts, Pulsed mode, Duty cycle 20%, Pulse duration 10 μs, energy density 636.9 J/cm2 per second, no water or air).
Infiltration anesthesia was injected for B group .
The laser tip was placed in angle ~30° with the gingival surface.
Short light paint brush strokes were used in the cervical-apical direction in all pigmented areas.
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The depigmentation procedure essentially involves laser ablation of epithelial layer of buccal gingiva containing melanin pigmentation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oral pigmentation index (DOPI)
Time Frame: Baseline
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Baseline
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Oral pigmentation index (DOPI)
Time Frame: 1 month post-operative
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1 month post-operative
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Oral pigmentation index (DOPI)
Time Frame: 1 year follow-up
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1 year follow-up
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Oral pigmentation index (DOPI)
Time Frame: 2 years follow-up
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2 years follow-up
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Melanin pigmentation index:
Time Frame: Baseline
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Baseline
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Melanin pigmentation index:
Time Frame: 1 month post-operative
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1 month post-operative
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Melanin pigmentation index:
Time Frame: 1 year follow-up
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1 year follow-up
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Melanin pigmentation index:
Time Frame: 2 years follow-up
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2 years follow-up
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Gingival Appearance
Time Frame: 1 month
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1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oral Hygiene Index
Time Frame: Baseline
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The Oral Hygiene Index is composed of the combined Debris Index and Calculus index, each of these index is in turn based on 12 numerical determinations representing the amount of debris or calculus found on the buccal and lingual surfaces of each of three segments of each dental arch. Criteria for classifying debris 0 No debris or stain present
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Baseline
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Oral Hygiene Index
Time Frame: 1 month post-operative
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The Oral Hygiene Index is composed of the combined Debris Index and Calculus index, each of these index is in turn based on 12 numerical determinations representing the amount of debris or calculus found on the buccal and lingual surfaces of each of three segments of each dental arch. Criteria for classifying debris 0 No debris or stain present
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1 month post-operative
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Gingival Index
Time Frame: Baseline
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The Gingival Index (Löe and Silness, 1963) was created for the assessment of the gingival condition and records qualitative changes in the gingiva. It scores the marginal and interproximal tissues separately on the basis of 0 to 3. The criteria are: 0= Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding. |
Baseline
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Gingival Index
Time Frame: 1 month post-operative
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The Gingival Index (Löe and Silness, 1963) was created for the assessment of the gingival condition and records qualitative changes in the gingiva. It scores the marginal and interproximal tissues separately on the basis of 0 to 3. The criteria are: 0= Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding. |
1 month post-operative
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Omar Hamadah, PhD, Damascus University
Publications and helpful links
General Publications
- Simşek Kaya G, Yapici Yavuz G, Sümbüllü MA, Dayi E. A comparison of diode laser and Er:YAG lasers in the treatment of gingival melanin pigmentation. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Mar;113(3):293-9. doi: 10.1016/j.tripleo.2011.03.005. Epub 2011 Jun 12.
- Nammour S, El Mobadder M, Namour M, Namour A, Rompen E, Maalouf E, Brugnera Junior A, Brugnera AP, Vescovi P, Zeinoun T. A Randomized Comparative Clinical Study to Evaluate the Longevity of Esthetic Results of Gingival Melanin Depigmentation Treatment Using Different Laser Wavelengths (Diode, CO(2), and Er:YAG). Photobiomodul Photomed Laser Surg. 2020 Mar;38(3):167-173. doi: 10.1089/photob.2019.4672. Epub 2020 Jan 17.
- Hegde R, Padhye A, Sumanth S, Jain AS, Thukral N. Comparison of surgical stripping; erbium-doped:yttrium, aluminum, and garnet laser; and carbon dioxide laser techniques for gingival depigmentation: a clinical and histologic study. J Periodontol. 2013 Jun;84(6):738-48. doi: 10.1902/jop.2012.120094. Epub 2012 Sep 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GulfLaserChapter
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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