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Completed

NCT Number: NCT04680806

Laser-Assisted Gingival Depigmentation

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.

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Key information

Conditions

Hyperpigmentation; Melanin Hyperpigmentation Hypopigmentation Laser-Induced Hyperpigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases Vitiligo

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Tamim Dental Polyclinic

Doha, 13876, Qatar

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Er,Cr:YSGG laser 2780 nm

Device

The depigmentation procedure essentially involves laser ablation of epithelial layer of buccal gingiva containing melanin pigmentation.

Diode laser 940 nm

Device

The depigmentation procedure essentially involves laser ablation of epithelial layer of buccal gingiva containing melanin pigmentation.

Primary outcomes

  1. Oral pigmentation index (DOPI)

    Time frame: 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)

  2. Oral pigmentation index (DOPI)

    Time frame: 1 month post-operative

    • 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)

  3. Oral pigmentation index (DOPI)

    Time frame: 1 year follow-up

    • 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)

  4. Oral pigmentation index (DOPI)

    Time frame: 2 years follow-up

    • 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)

  5. Melanin pigmentation index:

    Time frame: 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

  6. Melanin pigmentation index:

    Time frame: 1 month post-operative

    • 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

  7. Melanin pigmentation index:

    Time frame: 1 year follow-up

    • 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

  8. Melanin pigmentation index:

    Time frame: 2 years follow-up

    • 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

  9. Gingival Appearance

    Time frame: 1 month

    • Score 1:Pink vital appearance for the gingiva
    • Score 2: Pale Non-vital appearance for gingiva

Secondary outcomes

  1. Oral Hygiene Index

    Time frame: 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

    • 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.

  2. Oral Hygiene Index

    Time frame: 1 month post-operative

    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.

  3. Gingival Index

    Time frame: 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.

  4. Gingival Index

    Time frame: 1 month post-operative

    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.

Sponsors and collaborators

Lead sponsor

Academy of Laser Dentistry - Gulf Laser Chapter

Other

Collaborators

  • Damascus University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Dec 23, 2020
Registry last updated
Dec 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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