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

Gingival Pigmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05608057
• Other study ID #: Laser_VitC2022
• Status: Completed
• Phase: N/A
• Start date: October 22, 2022
• Est. completion date: March 24, 2023

Study information

• Verified date: April 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 24, 2023
• Est. primary completion date: March 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Pigmentation

Intervention

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

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.

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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