Hyperpigmentation; Melanin, Laser-Induced Hyperpigmentation
Conditions
Keywords
Depigmentation, Gingival Hyperpigmentation, Diode laser, Er,Cr:YSGG laser, Repigmentation
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.
Interventions
DEVICEEr,Cr:YSGG laser 2780 nm
The depigmentation procedure essentially involves laser ablation of epithelial layer of buccal gingiva containing melanin pigmentation.
DEVICEDiode laser 940 nm
The depigmentation procedure essentially involves laser ablation of epithelial layer of buccal gingiva containing melanin pigmentation.
Sponsors
Damascus University
Academy of Laser Dentistry - Gulf Laser Chapter
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral pigmentation index (DOPI) | Baseline | * 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: | Baseline | * 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 | 1 month | * Score 1:Pink vital appearance for the gingiva * Score 2: Pale Non-vital appearance for gingiva |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oral Hygiene Index | Baseline | 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 1. 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 2. Soft debris covering more than one third, but not more than two thirds, of the exposed tooth surface. 3. Soft debris covering more than two thirds of the exposed tooth surface. |
| Gingival Index | Baseline | 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. |
Countries
Qatar
Outcome results
None listed