Effect of Co-enzyme Q10 and Vitamin C Alone or in Combination After a Surgical Gingival Depigmentation

ConditionsDepigmentation Treatment Depigmentation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-45

SponsorAl-Azhar University

About this trial

This study aims to assess the clinical effectiveness of Co-enzyme Q10 and Vitamin C, applied individually or in combination after surgical gingival depigmentation.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Patient clinically diagnosed with periodontitis.

Pregnant or lactating females.

Patient with previous treatment of gingival hyperpigmentation.

History of hypersensitivity to any study material.

Trial design

Design model

Parallel

Treatments tested in this trial

surgical depigmentation
Procedure/Surgery
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.
Coenzyme Q10
Dietary supplement
Coenzyme Q10 administered according to the study protocol following surgical gingival depigmentation to evaluate its effect on wound healing and gingival depigmentation.
Vitamin C
Dietary supplement
Vitamin C administered according to the study protocol following surgical gingival depigmentation to evaluate its effect on wound healing and gingival depigmentation.
Surgical Gingival Depigmentation Coenzyme Q10 Vitamin C
Dietary supplement
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.

Treatment groups

20 Participants

are divided into 4 treatment groups

Group A: controlActive comparator 1 intervention

Group B: test IExperimental treatment 2 interventions

Group C: Test IIExperimental treatment 2 interventions

Group D: Test IIIExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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

Change in gingival pigmentation intensity that measured by using a standardized gingival pigmentation index (DOPI)

Time frame

1 week, 1 month and 3 months. ,6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Al-Azhar University

Lead sponsor

Source ClinicalTrials.gov

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