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CompletedNCT02143375Updated May 21, 2014

Gingival Depigmentation by Diode Laser

A Phase 1 interventional study of 810 Diode Laser in Laser-induced Hypopigmentation, sponsored by Shahid Beheshti University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-21.

Sponsored by Shahid Beheshti University of Medical Sciences · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study summary

Physiologic gingival pigmentation(PGP) is the most common type of gingival pigmentation and cosmetic concern particularly in gummy smile patients. Laser therapy is an effective and noninvasive treatment option. The aim of this study was to evaluate the efficacy of diod laser on the treatment of PGP in patients.

Read the detailed description

Preoperative and postoperative photographic and clinical observations about the gingival melanin pigmentation were made according to Dummett-Gupta Oral Pigmentation Index scoring criteria given by Dummett C.O. in 1964 The investigators classified pigmented gingiva in patients as:

  1. Mild:Pink to slightly brown
  2. Moderate:Deep brown or black
  3. Severe:Mixed in color Score in each tooth was taken including one full inter dental papilla. Observations were made in natural light. The assessment of the scoring of the pigmentation index were done by all the three examiners, and the agreed upon score was assigned to prevent individual variations.

The investigators compared the intensity of pigmentation in each patient in recall sessions after 1month and 3mounth postoperative.

02

Conditions studied

  • Laser-induced Hypopigmentation

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03

In context

Hypopigmentation

10 studies on the registry are indexed under Hypopigmentation; 2 are open to participants now.

Browse Hypopigmentation studies →

Lead sponsor

Shahid Beheshti University of Medical Sciences is the lead sponsor of 229 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 19 adult patients who had been referred to oral medicine department of Shahid Beheshti dental school with the chief complaint of melanin pigmentation were selected for inclusion in this study.

Exclusion criteria

Exclusion Criteria:

  1. Hyperpigmentation that was associated with systemic disease or drug administration,disease that could compromise wound healing (uncontrolled diabetes, disease)
  2. Pregnancy or lactation
  3. Evidence of relationship between hyperpigmentation and
  4. History of previous treatment of hyperpigmentation
  5. Smoking
  6. Periodontal problems
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    810 Diode Laser

    810 nm Diode Laser, contact, continuous wave,320micron,

    Device: 810 Diode Laser

Interventions

  • Device810 Diode Laser

    The 810-nm diode laser has energy and wavelength characteristics that specially target the soft tissues. It has an affinity for hemoglobin and melanin, so it is an excellent soft tissue laser and is applicated for cutting and coagulating gingival tissue.Today,sparse studies have been published assessing physiologic gingival pigmentation using diode laser,therefore the aim of this study was to evaluate the effect of diode laser on the treatment of gingival pigmentation in adult patients.

06

What researchers measure

Primary outcomes

  1. improvement of gingival pigmentation

    standard digital photographs were taken preoperative,1 month after laser therapy.

    Time frame: 1 month

Secondary outcomes

  1. changes in pigmentation based on standard digital photographs and index of Dummett et al.

    standard digital photographs were taken 3 months postoperative.

    Time frame: 3month

07

Study locations

1 site
  • Shahid Beheshti medical university,Dental Faculty
    Tehran, +98, Iran, Islamic Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02143375
Responsible party
Somayyeh Babaei (Dr, Shahid Beheshti University of Medical Sciences) — Principal investigator
First posted
May 21, 2014
Start date
Apr 2013
Primary completion
Jan 2014
Completion
Mar 2014
Last update
May 21, 2014

Study contacts

Mahin Bakhshi, DDS.MS
study chair · Associate Professor of Oral Medicine Department ,Shahid Beheshti Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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