Gingival Hyperpigmentation, Gingival Melanin Pigmentation
Conditions
Brief summary
The purpose of this study is to evaluate the clinical and histopathological efficacy of topical vitamin C applications using three modalities (topical gel, microneedling , and mesotherapy) in gingival depigmentation. Assessment includes clinical evaluation, CIELAB analysis via DOPI, and histopathological examination (Fontana-Masson staining).
Interventions
DRUGTopical Vitamin C ( control Arm)
Topical application of L-Ascorbic Acid gel (1000 mg in 5 ml distilled water with CMC and PEG), applied once daily on gingival hyperpigmented areas for 1 month.
PROCEDUREVitamin C mesotherapy
vitamin C mesotherapy was administered by delivering intra-mucosal microinjections of L-ascorbic acid into pigmented gingival tissues at the epithelium-connective tissue junction, providing targeted delivery to melanocyte-rich layers. . The treatment will be repeated 3 times with 1 week .
PROCEDUREMicroneedling technique
Gingival microneedling was performed using a Derma Pen A6 (12-needle row), with penetration depth adjusted to gingival thickness at 700 cycles/min (mode 6). Each gingival side was treated 30-40 seconds per tooth until bleeding points appeared.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Only the statistician performing the data analysis will be blinded to group assignments; all other participants and investigators are aware of the interventions.
Intervention model description
"Participants will be randomly assigned to one of three intervention groups: Topical Vitamin C gel application, Vitamin C via mesotherapy injection, Microneedling with Vitamin C. Each intervention will be applied according to standardized protocols, and clinical as well as histopathological assessments will be conducted to evaluate changes in gingival pigmentation over a 3-month period."
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
\- 1- Both genders aged from 20-35 years. 2- Patients clinically diagnosed with physiologic gingival melanin pigmentation in the maxillary and mandibular keratinized gingiva. 3- Patients complaining of compromised esthetics. 4- Patients should be systemically free any disease as verified by a medical history diagnostic sheet or via health questionnaire
Exclusion criteria
\- 1- Patient clinically diagnosed with periodontitis and / or manifest poor oral hygiene with high plaque and gingival indices 2- Pregnant or lactating females. 3- Patients with clinical diagnosed lesion in the area of interest primarily the gingivae encompassing the maxillary /mandibular anterior teeth e.g. pigmented lesion of intestinal polyposis syndrome, McCune-Albright syndrome and fibro-osseous lesions as florid osseous dysplasia. 4- Patient with previous treatment of gingival hyperpigmentation. 5- Patients with history of being allergic to the vitamin C. 6- Patients with any systemic disease ( e.g. Addison disease ) or drugs consumed that may cause clinical gingival hyperpigmentation 7- Patients who are active or previous smokers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dummet oral Pigmentation Index (DOPI). | baseline to 3 months | Evaluating the degree of melanin pigmentation at baseline and follow-up visits. Scoring was conducted by calibrated examiners under standardized lighting conditions to ensure reproducibility of clinical measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Melanin area fraction | baseline to 3 months | Quantitative assessment of gingival melanin pigmentation was performed by histopathological analysis of gingival tissue specimens stained with Fontana-Masson, and the mean melanin-containing area fraction was calculated at baseline and follow-up to evaluate pigmentation changes according to established morphometric methods used in clinical histopathological studies. |
| Patient satisfaction | 2 weeks , 1 month , and 3 months | To score degree of pain experienced during and after treatment and the degree of patient satisfaction with the cosmetic result of the procedure was used.2 weeks |
Countries
Egypt
Contacts
CONTACTkhawlah Q al-khalidi, BDS, MSc
Outcome results
None listed