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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05608057
Other study ID # Laser_VitC2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT05283668 - Effect of Injectable Platelet Rich Fibrin on Healing and Patient Satisfaction Following Laser Gingival Depigmentation Phase 4
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Recruiting NCT06312605 - The Adjunctive Role of Vitamin C on Pigment Recurrence (Randomized Clinical and Histological Trial) Phase 4
Not yet recruiting NCT05786885 - Microneedling With Vitamin C Versus Injectable Vitamin C for Depigmentation in Gingival Melanin Hyperpigmentation N/A