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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07708792
Acronym
GMDAcidRCT
Enrollment
30
Registered
2026-07-16
Start date
2026-08-01
Completion date
2026-11-01
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Pigmentation

Keywords

melanin, gingiva, depigmentation, pigmentation

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.

Interventions

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

Sponsors

Dijlah University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Esthetic Outcome of Gingival Melanin Depigmentation3 months after treatmentAssessment of the esthetic improvement following gingival melanin depigmentation with or without adjunctive acid application using the study's predefined esthetic evaluation method.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026