Microneedling With Vitamin C Versus Injectable Vitamin C for Depigmentation in Gingival Melanin Hyperpigmentation

NCT05786885 | Unknown

• 1 other identifier: 22091990
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is a randomized controlled clinical trial comparing the use of microneedling with vitamin C against injecting vitamin C for depigmentation in physiological gingival melanin hyperpigmentation in a group of patients attending the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University.

Conditions

Gingival Pigmentation

Outcome Measures

Primary Outcomes (2)

• Surface area of pigmentation

  an intraoral picture (labial view) showing the hyperpigmented gingiva of the patient, is uploaded to ImageJ software. the length of central incisor is measured intra orally from the incisal edge to the CEJ and used as a reference to adjust the image scale of the software. On ImageJ software, a line is drawn surrounding the pigmented area and the software automatically measures the surface area of the selected pigmented area

  Measured at baseline

• Surface area of pigmentation

  an intraoral picture (labial view) showing the hyperpigmented gingiva of the patient, is uploaded to ImageJ software. the length of central incisor is measured intra orally from the incisal edge to the CEJ and used as a reference to adjust the image scale of the software. On ImageJ software, a line is drawn surrounding the pigmented area and the software automatically measures the surface area of the selected pigmented area

  Measured at 3 months after the intervention.

Secondary Outcomes (5)

• Dummett-Gupta Oral Pigmentation Index

  Measured at baseline and 3 months after the intervention.

• Gingival thickness

  Measured at baseline and 3 months after the intervention.

• Pain (patient related outcome)

  Recorded daily, starting from the same day after the intervention, up to 7 days after the intervention.

• Pain (patient related outcome)

  7 days after the intervention.

• Patient Satisfaction

  Measured 3 months after the intervention.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Microneedling will be done with application of topical vitamin C paste for depigmentation

Procedure: Microneedling will be done with application of topical vitamin C paste for depigmentation

Control Group

ACTIVE COMPARATOR

Gingival depigmentation will be done by vitamin C injection only.

Procedure: Vitamin C injection

Interventions

Microneedling will be done with application of topical vitamin C paste for depigmentation PROCEDURE

A Dermapen device will be used to microneedle the gingival tissue (model M8) with 24 microneedles arranged in rows, which is adjusted with 1.5 mm depth at the 6th mode speed of 700 cycles/min. It will be used in intermittent motion on the affected area for 30-40 seconds / tooth. Once bleeding points are observed on all areas of the pigmented gingiva, it will be irrigated using saline solution and dried using sterile gauze. Topical vitamin C powder (1000 mg/ml) will be mixed with saline, and the resultant slurry mix will then be applied to the gingiva for 10 minutes.

Intervention Group

Vitamin C injection PROCEDURE

1-1.5 ml Vitamin C will be injected into the gingiva, using an insulin syringe, once weekly, for 3 weeks. All the injection procedures will be performed by the same operator. The treated area will be left without dressing in both groups.

Control Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients exhibiting physiological melanin hyperpigmentation in the anterior region of the upper or lower gingiva.
• Patients should be free from any systemic diseases according to modified Cornell Medical index.
• Non- smokers.

You may not qualify if:

• Patients with periodontal disease.
• Patients with endocrine disorders causing hyperpigmentation or drug induced gingival pigmentation.
• Pregnant or lactating females.
• Patients with known hypersensitivity to vitamin C.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 28, 2023
• Study Start: April 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2024
• Last Updated: March 28, 2023

Record last verified: 2023-03