Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202309613841955 Date of Approval: 13/09/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Microneedling Technique with Vitamin C Versus Surgical Abrasion in the Treatment of Gingival Racial Pigmentation: RCT
Official scientific title Microneedling Technique with Vitamin C Versus Surgical Abrasion in the Treatment of Gingival Racial Pigmentation: A randomized controlled trial
Brief summary describing the background and objectives of the trial The normal color of gingival tissues is pale pink, but part of the population has a gingival melanin pigmentation caused by excessive melanin deposition by the melanocytes mainly located in the basal and suprabasal cell layers of the epithelium.That varies according to the degree of keratinization, the thickness of the gingiva, the degree of vascularization and the presence of melanocytic cells. The gingiva may be pigmented either physiologically or pathologically, such as drugs, heavy metal ingestions/poisonings, endocrine disturbances, exposure to ultraviolet (UV) rays, inflammation, benign and malignant lesions, cultural intentional tattooing, and smoking .But, the most common pigmentations affecting the protective gingiva are lesions of melanocytic origin, or melanocytic pigmentation. For depigmentation of gingiva, different treatment modalities have been reported, such as bur abrasion, scraping, partial thickness flap, cryotherapy, electrosurgery and diode laser have been tried for depigmentation. The surgical approaches although the most commonly used to manage gingival hyperpigmentation are accompanied by fear, bleeding, pain, large postoperative wound and recurrence. In contrast to any other depigmentation procedure, in micro needling technique the patient was able to see these excellent aesthetic results after 3 days. However, healing after scalpel depigmentation takes 7-10 days, and other procedures take more than 2 weeks to heal. In addition, a dressing is not necessary after the procedure since microholes are created without perfused bleeding and heal quickly. It is reported that derma pen with ascorbic acid has been used very successfully in ginigval depigmention. Based on this background, the aim of this study was to evaluate and compare the effects of the surgical abrasion and microneedling technique with ascorbic acid for gingival depigmentation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 31/08/2023
Actual trial start date 31/08/2023
Anticipated date of last follow up 30/06/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL N/A
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Microneedling technique with vitamin C N/A Once A dermapen device model M5 with 24 microneedles arranged in rows, which will be adjusted with 0.25 mm depth at the 6th mode speed of 700 cycles/min will be used. 18
Control Group Surgical abrasion N/A Once The depigmentation will be performed by large size flame diamond bur started from the mucogingival junction toward the free gingival margin 18 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Racial gingival pigmention. - Patients with esthetic concern and with good oral hygiene. - Free from systemic diseases or any disease that cause oral pigmentation. - Good health. - Ability to maintain good oral hygiene as evidenced in recall visits. - Patients who are current or former smoker. - Females who are pregnant or lactating. - Medically compromised patients and systemic conditions precluding periodontal surgery. - Uncontrolled diabetes mellitus - Severe hematologic disorders (e.g. hemophilia or leukemia), uncontrolled infectious or metabolic diseases that could compromise normal healing, liver or kidney dysfunction/failure. - Acute infection in the area intended for gingival depigmention. - Thin gingival biotype or periodontal disease. - Any contraindication for periodontal surgery. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 40 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/11/2022 Research Ethics Committee Faculty of Dentistry Tanta University
Ethics Committee Address
Street address City Postal code Country
El Gash street Medical Campus Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Wound Healing Index Preoperative , postoperative, two weeks, one month, three months and six months postoperatively
Primary Outcome Hedin melanin index for extent of pigmented area  Preoperative , postoperative, two weeks, one month, three months and six months postoperatively
Secondary Outcome Visual analog scale Preoperative , postoperative, two weeks, one month, three months and six months postoperatively
Secondary Outcome Change in area of pigmentation Preoperative , postoperative, two weeks, one month, three months and six months postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic of the Department of Periodontology and Oral Medicine Faculty of Dentistry Tanta University ElGash street Medical Campus Tanta 31773 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Asmaa Alaaeldeen Mohamed Ghaly Abd Elmenaam Ryad Sebrbay Tanta 31733 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Periodontology and Oral Medicine Faculty of Dentistry Tanta University El Gash street Medical Campus Tanta 31773 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ebtesam Abd ELKhalek ElZefzaf El Gash street Medical Campus Tanta 31773 Egypt
Mohamed Hamdy Helal El Gash street Medical Campus Tanta 31773 Egypt
Asmaa Alaaeldeen Mohamed Ghaly Abd Elmenaam Ryad Sebrbay. Tanta 31733 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Principal Investigator Ebtesam ElZefzaf Ebtessamelzefzaf@gmail.com 00201016623307 El Gash street Medical Campus
City Postal code Country Position/Affiliation
Tanta 31773 Egypt Professor of Oral Medicine Periodontology Oral Diagnosis and Oral Radiology Faculty of Dentistry Tanta University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Helal Mohamedhamdyh313@gmail.com 00201007903356 El Gash street Medical Campus
City Postal code Country Position/Affiliation
Tanta 31773 Egypt Lecturer of Oral Medicine Periodontology Oral Diagnosis and Oral Radiology Faculty of Dentistry Tanta University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual data will be available (including data dictionaries) All of the individual participant data collected during the trial, after de-identification. Study protocol and informed consent form will be available Data will be available: - Immediately following publication with no end date. - For anyone who wishes to access the data - For any type (purpose) of analyses - Upon proposal(s) that should be directed to elsayedamr@yahoo.com Informed Consent Form,Study Protocol Immediately following publication. No end date. Proposals should be directed to elsayedamr@yahoo.com Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information