Effect of Co-enzyme Q10 and Vitamin C Alone or in Combination After a Surgical Gingival Depigmentation

NCT07677826 | Recruiting DMC

• 1 other identifier: P-ME-26-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the clinical effectiveness of Co-enzyme Q10 and Vitamin C, applied individually or in combination after surgical gingival depigmentation.

Conditions

Depigmentation Treatment; Depigmentation

Outcome Measures

Primary Outcomes (1)

• Change in gingival pigmentation intensity using the Dummett Oral Pigmentation Index (DOPI). The DOPI scale from 0 to 3, where:0 = No clinical pigmentation ,1 = Mild pigmentation , 2 = Moderate pigmentation 3 = Heavy pigmentation

  Change in gingival pigmentation intensity that measured by using a standardized gingival pigmentation index (DOPI)

  1 week, 1 month and 3 months. ,6 months

Study Arms (4)

control

ACTIVE COMPARATOR

Surgical Depigmentation Alone

Procedure: surgical depigmentation

test I

EXPERIMENTAL

Surgical Depigmentation + CoQ10

Procedure: surgical depigmentation; Dietary Supplement: Coenzyme Q10

Test II

EXPERIMENTAL

Surgical Depigmentation + Vitamin C

Procedure: surgical depigmentation; Dietary Supplement: Vitamin C

Test III

EXPERIMENTAL

Surgical Depigmentation + CoQ10 + Vitamin C

Procedure: surgical depigmentation; Dietary Supplement: Surgical Gingival Depigmentation Coenzyme Q10 Vitamin C

Interventions

surgical depigmentation PROCEDURE

Surgical gingival depigmentation performed using the conventional scalpel technique. The pigmented gingival epithelium is surgically removed under local anesthesia to eliminate melanin pigmentation and improve gingival esthetics.

Test II; Test III; control; test I

Coenzyme Q10 DIETARY_SUPPLEMENT

Coenzyme Q10 administered according to the study protocol following surgical gingival depigmentation to evaluate its effect on wound healing and gingival depigmentation.

test I

Vitamin C DIETARY_SUPPLEMENT

Vitamin C administered according to the study protocol following surgical gingival depigmentation to evaluate its effect on wound healing and gingival depigmentation.

Test II

Surgical Gingival Depigmentation Coenzyme Q10 Vitamin C DIETARY_SUPPLEMENT

Coenzyme Q10 and vitamin c administered according to the study protocol following surgical gingival depigmentation to evaluate its effect on wound healing and gingival repigmentation.

Test III

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy patient of both genders aged from 18-45 years.
• Presence of bilateral physiologic gingival pigmentation in the anterior maxillary or mandibular region DOPI grades III-IV only.
• Good oral hygiene.
• Thick gingival phenotype.

You may not qualify if:

• Patient clinically diagnosed with periodontitis.
• Pregnant or lactating females.
• Patient with previous treatment of gingival hyperpigmentation.
• History of hypersensitivity to any study material.
• Patients who are active or previous smokers.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of dental medicine for girls? ALAZHAR University, Cairo, egypt

Nāşir, Egypt

RECRUITING

MeSH Terms

Conditions

Vitiligo

Interventions

coenzyme Q10; Ascorbic Acid

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Central Study Contacts

nora abdelgawad associate professor, phd

CONTACT

+201019407891; noramohamed.26@azhar.edu.eg

nora abdelgawad abdelgawad, phd

CONTACT

021019407891

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of oral medicine and periodontology

Model Details: Surgical gingival depigmentation performed using the conventional scalpel technique under local anesthesia. The pigmented gingival epithelium is surgically removed to eliminate physiologic melanin pigmentation and improve gingival esthetics. The procedure is performed as the standard treatment for gingival hyperpigmentation in all study participants.

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 1, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)