Ascorbic Acid Versus Diode Laser in the Treatment of Gingival Hyperpigmentation

Ascorbic Acid Versus Diode Laser in the Treatment of Gingival Hyperpigmentation: Histological and Clinical Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Gingival Hyperpigmentaion
• Intervention / Treatment: Drug: Ascorbic Acid 500 MG; Device: diode laser

Detailed Description

Cosmetic dentistry is usually centered on aesthetic restorative procedures but it may also involve the appearance of the gingiva, especially when it is located in the anterior labial region. Oral pigmentation may be physiological or pathological in nature. Better esthetics results of depigmentation were achieved with diode laser than conventional scalpel and with rotary abrasion, also diode laser is effective and safe in removal of gingival hyperpigmentation and repigmentation doesn't occur.When choosing a depigmenting agent, it is important to differentiate between substances that are toxic to the melanocyte and substances that interrupt the key steps of melanogenesis. Vit. C interacts with copper ions at the tyrosinase-active site and inhibits action of the enzyme tyrosinase, thereby decreasing the melanin formation.

This randomized comparative clinical study was conducted on ten patients attending the outpatient clinic of the Oral Medicine and Periodontology department, Faculty of Dentistry, Ain Shams University and seeking treatment for their gingival hyperpigmentation for esthetic reason.

The study was conducted after receiving an ethical clearance from the Research Ethics Committee of Ain Shams University, Faculty of Dentistry; that the study follows the ethical guidelines of research. The patients clearly understood the purpose of this study and signed an informed consent.

According to the study results, vit C treated patients showed no or little repigmentation after six months post treatment. Conversely, diode laser treated patients showed significant recurrence of gingival pigmentation after six months post treatment. These could be attributed to the blocking effect of vitamin C on the existing melanocytes to form new melanoseomes, however diode laser cause removal of the existing melanocytes that may cause formation of new melanocytes (migrating from neighboring melanocytes from the adjacent area of the gingiva) with the ability of forming new melanosomes and causing repigmentation. Histopathological assessment revealed that both treatment modalities caused significant reduction in MAF after six months post treatment.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ascorbic acid; injection of 1 ml intamucosal ascorbic acid 3 times with 1 week interval	Drug: Ascorbic Acid 500 MG; ascorbic acid is vitamin that can cause gingival depigmentation
EXPERIMENTAL: diode laser; photothermolysis by diode laser in one session	Device: diode laser; diode laser is soft tissue laser case photothermolysis of melanoctes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction questionnaire	from scoring patients pain and cosmetic changes	immediate postopearive, 1 week, 1 month and 6 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Nevine H kheir ElDien, Professor, faculty of Dentistry- Ain Shams univesity

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 7, 2015
• Primary Completion (ACTUAL): September 10, 2016
• Study Completion (ACTUAL): September 10, 2016

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (ACTUAL): August 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 18, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: ascorbic acid; diode laser; gingival hyperpigmentation
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: FDASU-RECIM10201512

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No