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

Not Applicable

Completed

• Conditions: Gingival Pigmentation

• Registration Number: NCT05608057
• Lead Sponsor: Hams Hamed Abdelrahman

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-22
• Study First Submitted: 2022-11-01
• Study First Submitted QC: 2022-11-01
• Study First Posted: 2022-11-08
• Primary Completion: 2023-03-24
• Study Completion: 2023-03-24
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in gingival pigmentation score	baseline, 1 month, 2 months	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

Secondary Outcome Measures

Name	Time	Method
Change in pain score	up to 1 week	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.
Patient satisfaction	after 2 months	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

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt