Health Condition 1: K068- Other specified disorders of gingiva and edentulous alveolar ridge
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Physiologic gingival hyperpigmentation as diagnosed by recent classification of Periodontal and Peri-implant diseases 2017 2.Physiologic gingival hyperpigmentation in anterior aesthetic zone of maxillary gingiva 3. Adults seeking gingival depigmentation treatment for esthetic concerns. 4. Available/Willing to come for 4 subsequent visits and follow-ups 5.Adequate oral hygiene 6.No systemic illness
Exclusion criteria
Exclusion criteria: 1. Pathologic or drug-induced gingival pigmentation 2. Physiologic gingival pigmentation only in mandibular gingiva 3. Any systemic disease causing gingival hyperpigmentation 4. Smokers 5. Pregnant or lactating females 6. Patients with periodontal disease 7. Patients taking vitamin C supplements 7. Patients with hypersensitivity to ascorbic acid 8.Patient taking vitamin C supplements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in gingival pigmentation intensity score( Dummett- Gupta oral pigmentation index) 0: no clinical pigmentation(pink tissue),1: mild clinical pigmentation(mild light brown color), 2:moderate clinical pigmentation (medium brown or mixed pink and brown coloration,3: heavy clinical pigmentation(deep brown or blue-black tissue).Timepoint: Baseline and follow-up visits at 1,3,6 months after completion of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in gingival pigmentation extent score( Gingival pigmentation index) 0: Absence,1: spots of brown or black, 2: brown or black patches but not diffuse,3: diffuse brown or black pigmentationTimepoint: Baseline and follow-up visits at 1,3,6 months after completion of treatment;Change in Gingival pigmented area on digital photographs Timepoint: Baseline and follow-up visits at 1,3,6 months after completion of treatment;Change in Gingival Luminescence(L value: 0 to 100) on digital photographs Timepoint: Baseline and follow-up visits at 1,3,6 months after completion of treatment;Change in gingival melanin score(0-100)Timepoint: Baseline and follow-up visits at 1,3,6 months after completion of treatment;Change in Gingival thickness Timepoint: Baseline and follow-up visits at 1,3,6 months after completion of treatment;Correlation of change in gingival melanin score with skin melanin scoreTimepoint: Baseline and follow-up visits at 1,3,6 months after completion of treatment;Difference in patient reported color improvement and overall treatment satisfaction scoresTimepoint: Follow-up visits at 1,3,6 months after completion of treatment;Difference in patient reported Pain, Itching, Discomfort VAS scoresTimepoint: From the day of procedure upto 7 days | — |
Countries
India
Contacts
All India Institute of medical Sciences, New Delhi