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NCT Number: NCT07708792

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

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.

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Key information

Conditions

Gingival Pigmentation Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases Vitiligo

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Dijlah University

Other

Registry information

Acronym: GMDAcidRCT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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