Laser-Assisted Gingival Depigmentation

Laser-Induced Hyperpigmentation Clinical Trial

Official title:

Gingival Depigmentation With Er,Cr:YSGG and Diode Laser: Randomized Clinical Trial to Evaluate the Repigmentation and Patient Perceptions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04680806
• Other study ID #: GulfLaserChapter
• Status: Completed
• Phase: N/A
• Start date: April 5, 2015
• Est. completion date: October 20, 2019

Study information

• Verified date: December 2020
• Source: Academy of Laser Dentistry - Gulf Laser Chapter
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 20, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperpigmentation
• Hyperpigmentation; Melanin
• Hypopigmentation
• Laser-Induced Hyperpigmentation

Intervention

Device:
• Er,Cr:YSGG laser 2780 nm
The depigmentation procedure essentially involves laser ablation of epithelial layer of buccal gingiva containing melanin pigmentation.
• Diode laser 940 nm
The depigmentation procedure essentially involves laser ablation of epithelial layer of buccal gingiva containing melanin pigmentation.

Locations

Country	Name	City	State
Qatar	Dr. Tamim Dental Polyclinic	Doha

Sponsors (2)

Lead Sponsor	Collaborator
Academy of Laser Dentistry - Gulf Laser Chapter	Damascus University

Country where clinical trial is conducted

Qatar, 

References & Publications (3)

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 — View 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 Usi — View Citation

Simsek 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. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline
Primary	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)	1 month post-operative
Primary	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)	1 year follow-up
Primary	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)	2 years follow-up
Primary	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	Baseline
Primary	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	1 month post-operative
Primary	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	1 year follow-up
Primary	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	2 years follow-up
Primary	Gingival Appearance	Score 1:Pink vital appearance for the gingiva; Score 2: Pale Non-vital appearance for gingiva	1 month
Secondary	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.	Baseline
Secondary	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.	1 month post-operative
Secondary	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.	Baseline
Secondary	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.	1 month post-operative

External Links

•   Laser Treatment for Melanin Gingival Pigmentations: A Comparison Study for 3 Laser Wavelengths 2780, 940, and 445 nm.