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

NCT05608057 | Completed

• 1 other identifier: Laser_VitC2022
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Pigmentation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in pain score

  up to 1 week

• Patient satisfaction

  after 2 months

Study Arms (2)

Vitamin C mesotherapy

EXPERIMENTAL

Other: Vitamin C mesotherapy

Diode laser

ACTIVE COMPARATOR

Radiation: Diode laser

Interventions

Vitamin C mesotherapy OTHER

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

Vitamin C mesotherapy

Diode laser RADIATION

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.

Diode laser

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

Related Publications (1)

• Esmat SA, El-Sayed NM, Fahmy RA. Vitamin C mesotherapy versus diode laser for the esthetic management of physiologic gingival hyperpigmentation: a randomized clinical trial. BMC Oral Health. 2023 Nov 21;23(1):899. doi: 10.1186/s12903-023-03614-7.

  PMID: 37990224 DERIVED

MeSH Terms

Interventions

Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Sara Esmat, BDS

  Alexandria University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: October 22, 2022
• Primary Completion: March 24, 2023
• Study Completion: March 24, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

EG (1)