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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin C mesotherapy | Experimental |
| |
| Diode laser | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patient satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Esmat, BDS | Alexandria University, Faculty of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria Faculty of Dentistry | Alexandria | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37990224 | Derived | 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. |
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| ID | Term |
|---|---|
| D054023 | Lasers, Semiconductor |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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|
| 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. |
|
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 |