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Laser-Assisted Gingival Depigmentation

Primary Purpose

Hyperpigmentation; Melanin, Laser-Induced Hyperpigmentation

Status
Completed
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Er,Cr:YSGG laser 2780 nm
Diode laser 940 nm
Sponsored by
Academy of Laser Dentistry - Gulf Laser Chapter
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperpigmentation; Melanin focused on measuring Depigmentation, Gingival Hyperpigmentation, Diode laser, Er,Cr:YSGG laser, Repigmentation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dr. Tamim Dental Polyclinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Er,Cr:YSGG laser 2780 nm

Diode laser 940 nm

Arm Description

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%).

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.

Outcomes

Primary Outcome Measures

Oral pigmentation index (DOPI)
Score 1: No clinical pigmentation (pink-colored gingiva) Score 2: Mild clinical pigmentation (mild light brown color) Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown color) Score 4: Heavy clinical pigmentation (deep brown or bluish black color)
Oral pigmentation index (DOPI)
Score 1: No clinical pigmentation (pink-colored gingiva) Score 2: Mild clinical pigmentation (mild light brown color) Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown color) Score 4: Heavy clinical pigmentation (deep brown or bluish black color)
Oral pigmentation index (DOPI)
Score 1: No clinical pigmentation (pink-colored gingiva) Score 2: Mild clinical pigmentation (mild light brown color) Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown color) Score 4: Heavy clinical pigmentation (deep brown or bluish black color)
Oral pigmentation index (DOPI)
Score 1: No clinical pigmentation (pink-colored gingiva) Score 2: Mild clinical pigmentation (mild light brown color) Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown color) Score 4: Heavy clinical pigmentation (deep brown or bluish black color)
Melanin pigmentation index:
Score 0: No pigmentation Score 1: Solitary unit(s) of pigmentation in papillary gingiva without extension between neighboring solitary units Score 2: Formation of continuous ribbon extending from neighboring solitary units
Melanin pigmentation index:
Score 0: No pigmentation Score 1: Solitary unit(s) of pigmentation in papillary gingiva without extension between neighboring solitary units Score 2: Formation of continuous ribbon extending from neighboring solitary units
Melanin pigmentation index:
Score 0: No pigmentation Score 1: Solitary unit(s) of pigmentation in papillary gingiva without extension between neighboring solitary units Score 2: Formation of continuous ribbon extending from neighboring solitary units
Melanin pigmentation index:
Score 0: No pigmentation Score 1: Solitary unit(s) of pigmentation in papillary gingiva without extension between neighboring solitary units Score 2: Formation of continuous ribbon extending from neighboring solitary units
Gingival Appearance
Score 1:Pink vital appearance for the gingiva Score 2: Pale Non-vital appearance for gingiva

Secondary Outcome Measures

Oral Hygiene Index
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 Soft debris covering not more than one third of the tooth surface, or presence of extrinsic stains without other debris regardless of surface area covered Soft debris covering more than one third, but not more than two thirds, of the exposed tooth surface. Soft debris covering more than two thirds of the exposed tooth surface.
Oral Hygiene Index
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 Soft debris covering not more than one third of the tooth surface, or presence of extrinsic stains without other debris regardless of surface area covered Soft debris covering more than one third, but not more than two thirds, of the exposed tooth surface. Soft debris covering more than two thirds of the exposed tooth surface.
Gingival Index
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.
Gingival Index
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.

Full Information

First Posted
December 15, 2020
Last Updated
December 18, 2020
Sponsor
Academy of Laser Dentistry - Gulf Laser Chapter
Collaborators
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT04680806
Brief Title
Laser-Assisted Gingival Depigmentation
Official Title
Gingival Depigmentation With Er,Cr:YSGG and Diode Laser: Randomized Clinical Trial to Evaluate the Repigmentation and Patient Perceptions
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 5, 2015 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
October 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Academy of Laser Dentistry - Gulf Laser Chapter
Collaborators
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This randomized clinical trial evaluated the recurrence rates of physiological gingival pigments during 24 months follow-up and the patient perceptions after the ablative depigmentation using two laser wavelengths; Diode 940 nm and Er,Cr:YSGG 2780 nm.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperpigmentation; Melanin, Laser-Induced Hyperpigmentation
Keywords
Depigmentation, Gingival Hyperpigmentation, Diode laser, Er,Cr:YSGG laser, Repigmentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were randomly allocated to the two treatment groups: -Group A was treated by an Er,Cr:YSGG laser 2780 nm. -Group B: was treated with diode 940 nm Laser.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Allocation of the patients into the two treatment groups was carried out using randomization table with allocation ratio 1:1. Participants, investigator, the tree external clinical examiners were blinded about the allocation of the patient in the treatment group. Care provider didn't interfere in collecting and analysing the data.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Er,Cr:YSGG laser 2780 nm
Arm Type
Experimental
Arm Description
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%).
Arm Title
Diode laser 940 nm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Er,Cr:YSGG laser 2780 nm
Intervention Description
The depigmentation procedure essentially involves laser ablation of epithelial layer of buccal gingiva containing melanin pigmentation.
Intervention Type
Device
Intervention Name(s)
Diode laser 940 nm
Intervention Description
The depigmentation procedure essentially involves laser ablation of epithelial layer of buccal gingiva containing melanin pigmentation.
Primary Outcome Measure Information:
Title
Oral pigmentation index (DOPI)
Description
Score 1: No clinical pigmentation (pink-colored gingiva) Score 2: Mild clinical pigmentation (mild light brown color) Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown color) Score 4: Heavy clinical pigmentation (deep brown or bluish black color)
Time Frame
Baseline
Title
Oral pigmentation index (DOPI)
Description
Score 1: No clinical pigmentation (pink-colored gingiva) Score 2: Mild clinical pigmentation (mild light brown color) Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown color) Score 4: Heavy clinical pigmentation (deep brown or bluish black color)
Time Frame
1 month post-operative
Title
Oral pigmentation index (DOPI)
Description
Score 1: No clinical pigmentation (pink-colored gingiva) Score 2: Mild clinical pigmentation (mild light brown color) Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown color) Score 4: Heavy clinical pigmentation (deep brown or bluish black color)
Time Frame
1 year follow-up
Title
Oral pigmentation index (DOPI)
Description
Score 1: No clinical pigmentation (pink-colored gingiva) Score 2: Mild clinical pigmentation (mild light brown color) Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown color) Score 4: Heavy clinical pigmentation (deep brown or bluish black color)
Time Frame
2 years follow-up
Title
Melanin pigmentation index:
Description
Score 0: No pigmentation Score 1: Solitary unit(s) of pigmentation in papillary gingiva without extension between neighboring solitary units Score 2: Formation of continuous ribbon extending from neighboring solitary units
Time Frame
Baseline
Title
Melanin pigmentation index:
Description
Score 0: No pigmentation Score 1: Solitary unit(s) of pigmentation in papillary gingiva without extension between neighboring solitary units Score 2: Formation of continuous ribbon extending from neighboring solitary units
Time Frame
1 month post-operative
Title
Melanin pigmentation index:
Description
Score 0: No pigmentation Score 1: Solitary unit(s) of pigmentation in papillary gingiva without extension between neighboring solitary units Score 2: Formation of continuous ribbon extending from neighboring solitary units
Time Frame
1 year follow-up
Title
Melanin pigmentation index:
Description
Score 0: No pigmentation Score 1: Solitary unit(s) of pigmentation in papillary gingiva without extension between neighboring solitary units Score 2: Formation of continuous ribbon extending from neighboring solitary units
Time Frame
2 years follow-up
Title
Gingival Appearance
Description
Score 1:Pink vital appearance for the gingiva Score 2: Pale Non-vital appearance for gingiva
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Oral Hygiene Index
Description
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 Soft debris covering not more than one third of the tooth surface, or presence of extrinsic stains without other debris regardless of surface area covered Soft debris covering more than one third, but not more than two thirds, of the exposed tooth surface. Soft debris covering more than two thirds of the exposed tooth surface.
Time Frame
Baseline
Title
Oral Hygiene Index
Description
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 Soft debris covering not more than one third of the tooth surface, or presence of extrinsic stains without other debris regardless of surface area covered Soft debris covering more than one third, but not more than two thirds, of the exposed tooth surface. Soft debris covering more than two thirds of the exposed tooth surface.
Time Frame
1 month post-operative
Title
Gingival Index
Description
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.
Time Frame
Baseline
Title
Gingival Index
Description
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.
Time Frame
1 month post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Hamadah, PhD
Organizational Affiliation
Damascus University
Official's Role
Study Director
Facility Information:
Facility Name
Dr. Tamim Dental Polyclinic
City
Doha
ZIP/Postal Code
13876
Country
Qatar

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
there is no plan to make individual participant data (IPD) available
Citations:
PubMed Identifier
22676819
Citation
Simsek Kaya G, Yapici Yavuz G, Sumbullu 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.
Results Reference
result
PubMed Identifier
31951510
Citation
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, CO2, and Er:YAG). Photobiomodul Photomed Laser Surg. 2020 Mar;38(3):167-173. doi: 10.1089/photob.2019.4672. Epub 2020 Jan 17.
Results Reference
result
PubMed Identifier
23003920
Citation
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.
Results Reference
result
Links:
URL
https://doi.org/10.1155/2020/3896386
Description
Laser Treatment for Melanin Gingival Pigmentations: A Comparison Study for 3 Laser Wavelengths 2780, 940, and 445 nm.

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Laser-Assisted Gingival Depigmentation

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