Vitamin C Mesotherapy Versus Diode Laser for the Management of Physiologic Gingival Pigmentation

Vitamin C Mesotherapy Versus Diode Laser for the Management of Physiologic Gingival Pigmentation (Randomized Controlled Clinical Trial)

Physiologic pigmentation affects the gingival esthetics. Laser ablation has been recently used as the most effective and reliable technique for gingival depigmentation. However, the high cost of laser technology limits its use in dental practice. Vitamin C/Ascorbic acid mesotherapy has been proposed as a minimally invasive, safe, cost-effective new modality of treatment.

Study Overview

• Status: Completed
• Conditions: Gingival Pigmentation
• Intervention / Treatment: Other: Vitamin C mesotherapy; Radiation: Diode laser

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Esmat, BDS; Phone Number: 01004063594; Email: Sara.esmat.dent@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults between 18 and 45 years old with physiologic melanin pigmentation in the anterior esthetic portion of the maxillary or mandibular gingiva.
• Systemically free

Exclusion Criteria:

• Smokers.
• Drugs intake, which associates with gingival melanin pigmentation.
• Pregnant and lactating women.
• Patients with known hypersensitivity to ascorbic acid.
• Patients with bad oral hygiene.
• Pigmentation of the gingiva due to heavy metal ingestion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin C mesotherapy	Other: Vitamin C mesotherapy; Vitamin C intra-mucosal injection; in which the site of interest will be anesthetized using a topical anesthetic agent (lidocaine gel or xylocaine gel) or infiltration anesthesia, followed by intra-mucosal field injections of 1-1.5 ml Cevarol (L-Ascorbic acid 1000 mg/5 ml
Active Comparator: Diode laser	Radiation: Diode laser; Diode laser ablation: in which the site of interest will be anesthetized using infiltration anesthesia, followed by laser ablation. 980nm Diode laser will be applied using the following setting parameters: continuous mode with 980nm wavelength at 1.5 W output power.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gingival pigmentation score	Score 0: Absence of pigmentation Score 1: Spots of brown to black color or pigments. Score 2: Brown to black patches but not diffuse pigmentation Score 3: Diffuse brown to black pigmentation, marginal, and attached gingiva	baseline, 1 month, 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain score	Visual Analogue Scale (VAS) is a simple measurement tool that measures the intensity of pain as recorded by the patient. 10 point visual analog scale of pain rating, the left side is marked "no pain" and the right side marked "worst pain imaginable.	up to 1 week
Patient satisfaction	After 2 months, patients will be asked to answer three questions to evaluate the level of satisfaction with each technique: Did you notice a cosmetic change 2 months after the treatment? (1) No, (2) Moderate, (3) Marked Did treatment meet your expectation? (1) No, (2) yes, (3) Over and above Would you repeat treatment if necessary? (1) No, (2) yes	after 2 months

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman
• Investigators: Principal Investigator: Sara Esmat, BDS, Alexandria University, Faculty of dentistry

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2022
• Primary Completion (Actual): March 24, 2023
• Study Completion (Actual): March 24, 2023

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: Laser_VitC2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No