Ascorbic Acid Versus Diode Laser in the Treatment of Gingival Hyperpigmentation

NCT03252418 | Completed Phase 4 DMC

• 1 other identifier: FDASU-RECIM10201512
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

Vitamin C affect the melanocytes function not the number while diode laser cause melanocytes destruction. Although diode laser and vitamin C have proved their effectiveness in depigmentation in previous studies, there are no published studies compared the effect of diode laser and vitamin C on melanocytes and melanosomes clinically and histologically.

Conditions

Gingival Hyperpigmentaion

Keywords

ascorbic acid; diode laser; gingival hyperpigmentation

Outcome Measures

Primary Outcomes (3)

• Dummett oral pigmentaion index (DOPI)

  scoring from 0 ( no pigmentation to 3 (sever pigmentation

  change from baseline to 1, 3 and 6 months

• gingival brightness (ΔL)

  using spectrophotometer

  change from baseline to 1, 3 and 6 months

• histological mean area fraction of melanosomes

  by taking soft tissue samples and stained by fontana masson stain

  change from baseline to 6 months

Secondary Outcomes (1)

• patient satisfaction questionnaire

  immediate postopearive, 1 week, 1 month and 6 months

Study Arms (2)

ascorbic acid

EXPERIMENTAL

injection of 1 ml intamucosal ascorbic acid 3 times with 1 week interval

Drug: Ascorbic Acid 500 MG

diode laser

EXPERIMENTAL

photothermolysis by diode laser in one session

Device: diode laser

Interventions

Ascorbic Acid 500 MG DRUG

ascorbic acid is vitamin that can cause gingival depigmentation

ascorbic acid

diode laser DEVICE

diode laser is soft tissue laser case photothermolysis of melanoctes

diode laser

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female patients with age ranging from 18 years old to 40 years old.
• Bilaterally symmetric gingival hyperpigmentation on the maxillary and mandibular labial keratinized gingiva between canines.
• Patients free from any systemic diseases as evidenced by the health questionnaire, using modified Cornell medical index (Pendleton et al., 2004).
• Patients with thick gingival biotype ≥ 3 mm.

You may not qualify if:

• Presence of local condition that may cause gingival hyperpigmentation (traumatized epithelium caused by defective fixed prosthesis or restoration).
• Smokers.
• Pregnant or lactating females.
• Patients with poor oral hygiene, incompliance to treatment and persistence gingival inflammation after phase I periodontal therapy.
• Clinically diagnosed periodontitis (attachment and bone loss, presence of periodontal pockets, gingival recession and tooth mobility).
• Previous treatment to pigmentation.
• Patients taking supplementary vitamin C for any reason.
• Known sensitivity to ascorbic acid or any of its derivatives.
• Patients taking any drug that may cause gingival pigmentation.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

Ascorbic Acid; Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Nevine H kheir ElDien, Professor

  faculty of Dentistry- Ain Shams univesity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: when measuring the gingival brightness and MAF of melanosomes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of oral medicine and periodontology

Model Details: treating of gingival hyperpigmentation by two different methods

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 17, 2017
• Study Start: October 7, 2015
• Primary Completion: September 10, 2016
• Study Completion: September 10, 2016
• Last Updated: August 22, 2017

Record last verified: 2017-08