The Adjunctive Role of Vitamin C on Pigment Recurrence (Randomized Clinical and Histological Trial)

NCT06312605 | Recruiting Phase 4 DMC

• 1 other identifier: 230620
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine the role of vitamin C on recurrence of gingival pigment after patients who are healthy and esthetically concerned with it received surgical removal of this pigment. The main question\[s\] it aims to answer are:

• Pigment recurrence after one year.
• Patient satisfaction and histological response of tissues. Participants will be asked to come on regular follow up visits one group will receive vitamin C injection other will be asked to apply topical vitamin C on a specific regimen. Researcher will compare the groups who received injectable vitamin C with those who topically applied it to see the effect of each.

Conditions

Gingival Pigmentation

Keywords

Gingival pigmentation /Pigment recurrence /Vitamin C

Outcome Measures

Primary Outcomes (3)

• Pigmentation scores

  Dummet oral pigmentation index (DOPI) ,score (0-3), 0 = pink tissue \[no clinical pigmentation\]; 1 = mild light brown tissue \[mild clinical pigmentation\]; 2 = medium brown or mixed brown and pink tissue \[moderate clinical pigmentation\]; or 3 = deep brown/ blue-black tissue (heavy clinical pigmentation)

  baseline (immediately before surgical depigmentation), one month, three months, six months, nine months and finally after 12 months post operatively

• Assessment of pigment surface area (SA)

  Standardized photos are taken and introduced into image J software after cropping interest area to calculate surface area of the pigment

  baseline (immediately before surgical depigmentation), one month, three months, six months, nine months and finally after 12 months post operatively

• Assessment of pigment intensity in terms of mean darkness value (MDV)

  Standardized photos are taken and introduced into image J software after cropping interest area to calculate intensity of pigment

  baseline (immediately before surgical depigmentation), one month, three months, six months, nine months and finally after 12 months post operatively

Secondary Outcomes (2)

• Patient satisfaction

  After 12 months

• Histological response

  baseline - 6 months -after a year

Study Arms (3)

Intramucosal vitamin C injection

ACTIVE COMPARATOR

After surgical gingival depigmentation, injectable vitamin C (Redox C 500 mg) using insulin syringe(29 Gauge 1cc 0.33mm x 8mm 5/16 needle) is applied at gingival sites 0.1 ml for each point that should be 3 mm. The regimen is done once weekly for a month then once a month for additional 5 months.

Procedure: Injectable applied vitamin C

(Vitamin C topical gel

ACTIVE COMPARATOR

After surgical gingival depigmentation, patients in this group apply ascorbic acid containing gel prepared by Nawah Scientific Research Center. The micro emulsion was prepared by mixing tween 20 (4.66% w/w) as surfactant and isopropanol (2.3% w/w) as co-surfactant using magnetic stirring then diluted drop-wise with Vitamin C solution in water (10% w/w). The formed micro emulsion was then converted into gel using Poloxamer 407 (20% w/w) that was added at 4°C under continuous magnetic stirring

Procedure: Topical applied Vitamin C

Control group

PLACEBO COMPARATOR

Surgical gingival depigmentation is carried out for these patients

Procedure: Surgical depigmentation only

Interventions

Injectable applied vitamin C PROCEDURE

Surgical gingival depigmentation is done for all participants, after then they receive injectable vitamin C

Intramucosal vitamin C injection

Topical applied Vitamin C PROCEDURE

Surgical gingival depigmentation is done for all participants, after then they are instructed to apply topical vitamin C

(Vitamin C topical gel

Surgical depigmentation only PROCEDURE

Surgical gingival depigmentation only without any drug

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Both genders aged from 18-40. Systemically free patients from any disease as evidenced by the health questionnaire, using modified Cornell medical index and classified as ASA class I.
• Patients who were diagnosed to have physiological gingival melanin pigmentation on the maxillary or mandibular keratinized gingiva with Dummett oral pigmentation score 2 or more.
• Patients with thick gingival phenotype ≥ 1.5 mm.

You may not qualify if:

• Pregnant or lactating females Smokers (water pipe, cigar or cigarette smoking). Patients taking or have taken any drug that may cause gingival depigmentation as chloroquine, minocycline, zidovudine, chlorpromazine, ketoconazole and bleomycin .
• Any cause for supplemental intake of vitamin C. Reported allergy to ascorbic acid or to any of its derivatives as reported in health questionnaire .
• Clinically diagnosed periodontitis regarding the following criteria probing depth \>3mm, clinical attachment loss ≥ 1mm and bleeding on probing \> 10% .
• Patients with poor oral hygiene, incompliant to treatment and persistence gingival inflammation after phase I periodontal therapy.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty AinShams University

Cairo, Egypt

RECRUITING

Related Links

• Efficacy of surgical laser therapy in the management of oral pigmented lesions: A systematic review
• Gingival Depigmentation Using Scalpel Technique: A Case Report
• An insight into gingival depigmentation techniques: The pros and cons

Study Officials

• Hala K. Abd-El-Gaber, Professor

  Professor of Oral Medicine, Oral Diagnosis and Periodontology Faculty of Dentistry - Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman O. Hashem, MSc

CONTACT

01025743781; emanemmy123456@gmail.com

Ola M. Ezzatt, Assistant Professor

CONTACT

0128794479; d.ola@asfd.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Coding of the groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator at oral medicine and periodontology

Model Details: All participants receive surgical depigmentation then either vitamin C is applied following 2 regimens

Study Record Dates

• First Submitted: March 9, 2024
• First Posted: March 15, 2024
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

EG (1)