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

July 11, 2026 updated by: Dijlah University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adjunctive Acid Group
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
Adjunctive topical application of citric acid during gingival melanin depigmentation according to the study protocol to evaluate its effect on esthetic outcomes and healing.
Active Comparator: Control Group
Participants receive gingival melanin depigmentation using the standard surgical technique without adjunctive acid application.
Drug: Citric acid
Adjunctive topical application of citric acid during gingival melanin depigmentation according to the study protocol to evaluate its effect on esthetic outcomes and healing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Esthetic Outcome of Gingival Melanin Depigmentation
Time Frame: 3 months after treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dijlah University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

July 11, 2026

First Submitted That Met QC Criteria

July 11, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 11, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 83

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because informed consent for public data sharing was not obtained, and sharing could compromise participant confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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