Gingival PigmentationGMDAcidRCTNCT07708792
Influence of Adjunctive Acids Use on Esthetic Outcomes of Gingival Melanin Depigmentation: A Periodontal-Operative Pilot Randomized Clinical Trial
A study testing Citric acid in people with Gingival Pigmentation, run by Dijlah University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Gingival Pigmentation
- What is being tested?
- Citric acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
- Being tested
- Citric acid
- Keywords
- melanin, gingiva, depigmentation, pigmentation
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citric acidDrug
Adjunctive topical application of citric acid during gingival melanin depigmentation according to the study protocol to evaluate its effect on esthetic outcomes and healing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Citric acid |
| Control Group | Active comparator | Participants receive gingival melanin depigmentation using the standard surgical technique without adjunctive acid application. Receives: Drug: Citric acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival PigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dijlah University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708792
- Sponsor's protocol ID
- 83
- Acronym
- GMDAcidRCT
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because informed consent for public data sharing was not obtained, and sharing could compromise participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Adjunctive Acids Use on Esthetic Outcomes of Gingival Melanin Depigmentation: A Periodontal-Operative Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07708792
- Acronym / sponsor ID
- GMDAcidRCT / 83
- Conditions
- Gingival Pigmentation
- Keywords
- melanin, gingiva, depigmentation, pigmentation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dijlah UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjunctive Acid Group | Experimental | Drug: Citric acidParticipants receive gingival melanin depigmentation using the standard surgical technique with adjunctive application of the study acid according to the study protocol. |
| Control Group | Active comparator | Drug: Citric acidParticipants receive gingival melanin depigmentation using the standard surgical technique without adjunctive acid application. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citric acidAdjunctive topical application of citric acid during gingival melanin depigmentation according to the study protocol to evaluate its effect on esthetic outcomes and healing. | Drug | Adjunctive Acid Group, Control Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because informed consent for public data sharing was not obtained, and sharing could compromise participant confidentiality.
Related trials for Gingival Pigmentation
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Effect of Co-enzyme Q10 and Vitamin C Alone or in Combination After a Surgical Gingival Depigmentation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Citric acid in people with Gingival Pigmentation, run by Dijlah University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esthetic Outcome of Gingival Melanin Depigmentation (time frame: 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.