Gingival Depigmentation by Diode Laser

NCT ID: NCT02143375

Last Updated: 2014-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Laser-induced Hypopigmentation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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810 Diode Laser

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

Group Type EXPERIMENTAL

810 Diode Laser

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Somayyeh Babaei

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahin Bakhshi, DDS.MS

Role: STUDY_CHAIR

Associate Professor of Oral Medicine Department ,Shahid Beheshti Medical University

Locations

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Shahid Beheshti medical university,Dental Faculty

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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mbakhshi

Identifier Type: -

Identifier Source: org_study_id

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