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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Group | Active Comparator | Participants receive gingival melanin depigmentation using the standard surgical technique without adjunctive acid application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Individual participant data will not be shared because informed consent for public data sharing was not obtained, and sharing could compromise participant confidentiality.
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D019343 | Citric Acid |
| ID | Term |
|---|---|
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| D009930 |
| Organic Chemicals |