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

Ffect of Co-enzyme Q10 and Vitamin C Alone or in Combination After a Surgical Gingival Depigmentation a Randomized Clinical Study

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

Study Overview

• Status: Recruiting
• Conditions: Depigmentation; Depigmentation Treatment
• Intervention / Treatment: Procedure: surgical depigmentation; Dietary supplement: Coenzyme Q10; Dietary supplement: Vitamin C; Dietary supplement: Surgical Gingival Depigmentation Coenzyme Q10 Vitamin C

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: nora abdelgawad associate professor, phd; Phone Number: +201019407891; Email: noramohamed.26@azhar.edu.eg
• Study Contact Backup: Name: nora abdelgawad abdelgawad, phd; Phone Number: 021019407891

Study Locations

• Egypt
  • Nāşir, Egypt
    • Recruiting
    • Faculty of dental medicine for girls? ALAZHAR University, Cairo, egypt
    • Contact: Nora Abdelgawad Associate professor, Phd; Phone Number: +×01019407891; Email: Noramohamed.26@azhar.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control; Surgical Depigmentation Alone	Procedure: surgical depigmentation; 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.
Experimental: test I; Surgical Depigmentation + CoQ10	Procedure: surgical depigmentation; 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.; Dietary supplement: Coenzyme Q10; Coenzyme Q10 administered according to the study protocol following surgical gingival depigmentation to evaluate its effect on wound healing and gingival depigmentation.
Experimental: Test II; Surgical Depigmentation + Vitamin C	Procedure: surgical depigmentation; 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.; Dietary supplement: Vitamin C; Vitamin C administered according to the study protocol following surgical gingival depigmentation to evaluate its effect on wound healing and gingival depigmentation.
Experimental: Test III; Surgical Depigmentation + CoQ10 + Vitamin C	Procedure: surgical depigmentation; 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.; Dietary supplement: Surgical Gingival Depigmentation Coenzyme Q10 Vitamin C; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 20, 2026

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hypopigmentation; Pigmentation Disorders; Skin and Connective Tissue Diseases; Vitiligo; Organic Chemicals; Carbohydrates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Ascorbic Acid; coenzyme Q10
• Other Study ID Numbers: P-ME-26-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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