Gingival Depigmentation by Diode Laser

Laser-induced Hypopigmentation Clinical Trial

Official title:

Efficacy of810 nm Diode Laser on Gingival Pigmentation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143375
• Other study ID #: mbakhshi
• Status: Completed
• Phase: Phase 1
• First received: April 28, 2014
• Last updated: May 18, 2014
• Start date: April 2013
• Est. completion date: March 2014

Study information

• Verified date: April 2013
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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:

1. Hyperpigmentation that was associated with systemic disease or drug administration,disease that could compromise wound healing (uncontrolled diabetes, autoimmune disease)

2. Pregnancy or lactation

3. Evidence of relationship between hyperpigmentation and malignancy

4. History of previous treatment of hyperpigmentation

5. Smoking

6. Periodontal problems

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypopigmentation
• Laser-induced Hypopigmentation

Intervention

Device:
• 810 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahid Beheshti medical university,Dental Faculty	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of gingival pigmentation	standard digital photographs were taken preoperative,1 month after laser therapy.	1 month	Yes
Secondary	changes in pigmentation based on standard digital photographs and index of Dummett et al.	standard digital photographs were taken 3 months postoperative.	3month	Yes