Influence of Adjunctive Acids Use on Esthetic Outcomes of Gingival Melanin Depigmentation: A Periodontal-Operative Pilot Randomized Clinical Trial

NCT07708792 | Not Yet Recruiting DMC

• 1 other identifier: 83
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This pilot randomized clinical trial aims to evaluate the effect of adjunctive acid application on the esthetic outcomes of gingival melanin depigmentation. Participants with physiologic gingival hyperpigmentation will be randomly assigned to receive conventional gingival depigmentation with or without adjunctive acid application. The primary outcome is the improvement in gingival esthetics, while secondary outcomes include postoperative healing, pain, patient satisfaction, and recurrence of pigmentation. The findings of this study may help identify whether adjunctive acid application improves the clinical outcomes of gingival depigmentation procedures.

Conditions

Gingival Pigmentation

Keywords

melanin, gingiva, depigmentation, pigmentation

Outcome Measures

Primary Outcomes (1)

• Esthetic Outcome of Gingival Melanin Depigmentation

  Assessment of the esthetic improvement following gingival melanin depigmentation with or without adjunctive acid application using the study's predefined esthetic evaluation method.

  3 months after treatment

Study Arms (2)

Adjunctive Acid Group

EXPERIMENTAL

Participants receive gingival melanin depigmentation using the standard surgical technique with adjunctive application of the study acid according to the study protocol.

Drug: Citric acid

Control Group

ACTIVE COMPARATOR

Participants receive gingival melanin depigmentation using the standard surgical technique without adjunctive acid application.

Drug: Citric acid

Interventions

Citric acid DRUG

Adjunctive topical application of citric acid during gingival melanin depigmentation according to the study protocol to evaluate its effect on esthetic outcomes and healing.

Adjunctive Acid Group; Control Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18-50 years.
• Presence of physiologic gingival melanin pigmentation requiring treatment.
• Good general health.
• Good periodontal health or a healthy periodontium after initial periodontal therapy.
• Willingness to participate and provide written informed consent.
• Ability to attend all follow-up visits.

You may not qualify if:

• Current smokers or tobacco users.
• Pregnancy or breastfeeding.
• History of systemic diseases that may affect wound healing (e.g., uncontrolled diabetes or immunocompromised conditions).
• Use of medications known to affect gingival pigmentation or wound healing.
• Previous gingival depigmentation treatment in the study area.
• Active periodontal disease or oral infection. Known allergy or hypersensitivity to the study acid or related materials.

Sponsors & Collaborators

• Dijlah University: lead

MeSH Terms

Conditions

Vitiligo

Interventions

Citric Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share