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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-22

Study Completion Date

2023-03-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Gingival Pigmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Vitamin C mesotherapy

Group Type EXPERIMENTAL

Vitamin C mesotherapy

Intervention Type 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

Diode laser

Group Type ACTIVE_COMPARATOR

Diode laser

Intervention Type 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.

Interventions

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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

Intervention Type OTHER

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.

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No