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Completed

NCT Number: NCT02143375

Gingival Depigmentation by Diode Laser

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shahid Beheshti medical university,Dental Faculty

Tehran, Tehran Province, +98, Iran

About this study

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:

  • Mild:Pink to slightly brown
  • Moderate:Deep brown or black
  • 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.

Who can participate

Healthy volunteers accepted: Yes

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

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

  • Hyperpigmentation that was associated with systemic disease or drug administration,disease that could compromise wound healing (uncontrolled diabetes, autoimmune disease)
  • Pregnancy or lactation
  • Evidence of relationship between hyperpigmentation and malignancy
  • History of previous treatment of hyperpigmentation
  • Smoking
  • Periodontal problems

Treatment and study plan

810 Diode Laser

Device

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.

Primary outcomes

  1. improvement of gingival pigmentation

    Time frame: 1 month

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

Secondary outcomes

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

    Time frame: 3month

    standard digital photographs were taken 3 months postoperative.

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

Efficacy of810 nm Diode Laser on Gingival Pigmentation

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 21, 2014
Registry last updated
May 21, 2014

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.