Gingival Pigmentation
Conditions
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.
Interventions
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
RADIATIONDiode 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.
Sponsors
Hams Hamed Abdelrahman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed