Depigmentation, Depigmentation Treatment
Conditions
Brief summary
This study aims to assess the clinical effectiveness of Co-enzyme Q10 and Vitamin C, applied individually or in combination after surgical gingival depigmentation.
Interventions
PROCEDUREsurgical depigmentation
Surgical gingival depigmentation performed using the conventional scalpel technique. The pigmented gingival epithelium is surgically removed under local anesthesia to eliminate melanin pigmentation and improve gingival esthetics.
DIETARY_SUPPLEMENTCoenzyme Q10
Coenzyme Q10 administered according to the study protocol following surgical gingival depigmentation to evaluate its effect on wound healing and gingival depigmentation.
DIETARY_SUPPLEMENTVitamin C
Vitamin C administered according to the study protocol following surgical gingival depigmentation to evaluate its effect on wound healing and gingival depigmentation.
DIETARY_SUPPLEMENTSurgical Gingival Depigmentation Coenzyme Q10 Vitamin C
Coenzyme Q10 and vitamin c administered according to the study protocol following surgical gingival depigmentation to evaluate its effect on wound healing and gingival repigmentation.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Surgical gingival depigmentation performed using the conventional scalpel technique under local anesthesia. The pigmented gingival epithelium is surgically removed to eliminate physiologic melanin pigmentation and improve gingival esthetics. The procedure is performed as the standard treatment for gingival hyperpigmentation in all study participants.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Systemically healthy patient of both genders aged from 18-45 years. * Presence of bilateral physiologic gingival pigmentation in the anterior maxillary or mandibular region DOPI grades III-IV only. * Good oral hygiene. * Thick gingival phenotype.
Exclusion criteria
* Patient clinically diagnosed with periodontitis. * Pregnant or lactating females. * Patient with previous treatment of gingival hyperpigmentation. * History of hypersensitivity to any study material. * Patients who are active or previous smokers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in gingival pigmentation intensity using the Dummett Oral Pigmentation Index (DOPI). The DOPI scale from 0 to 3, where:0 = No clinical pigmentation ,1 = Mild pigmentation , 2 = Moderate pigmentation 3 = Heavy pigmentation | 1 week, 1 month and 3 months. ,6 months | Change in gingival pigmentation intensity that measured by using a standardized gingival pigmentation index (DOPI) |
Countries
Egypt
Contacts
CONTACTnora abdelgawad associate professor, phd
CONTACTnora abdelgawad abdelgawad, phd
Outcome results
None listed