Vitamin C's effect on gingival pigment recurrence after removal
Patient Response and Recurrence Rate Following Adjunctive Intra-Mucosal or Topical Ascorbic Acid To Gingival Depigmentation Using Surgical Scalpel Technique: (Randomized Clinical and Histological Trial)
This study tests if giving vitamin C through injections or applying it on the skin can help prevent the return of gum discoloration after it's been removed in healthy patients who care about their appearance.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06312605 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of vitamin C on the recurrence of gingival pigmentation following surgical removal in healthy patients concerned about aesthetics. Participants will be divided into two groups: one receiving injectable vitamin C and the other applying it topically, with follow-up visits to assess pigment recurrence and patient satisfaction over one year. The study aims to compare the histological responses of the tissues in both groups to determine the most effective method of vitamin C administration.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 18-40 with physiological gingival melanin pigmentation and a thick gingival phenotype.
Not a fit: Patients who are pregnant, lactating, smokers, or have conditions that may affect vitamin C metabolism or cause gingival depigmentation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for preventing gingival pigment recurrence, enhancing patient satisfaction with aesthetic outcomes.
How similar studies have performed: Previous studies have shown promising results for vitamin C in treating gingival pigmentation, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Both genders aged from 18-40. Systemically free patients from any disease as evidenced by the health questionnaire, using modified Cornell medical index and classified as ASA class I. Patients who were diagnosed to have physiological gingival melanin pigmentation on the maxillary or mandibular keratinized gingiva with Dummett oral pigmentation score 2 or more. Patients with thick gingival phenotype ≥ 1.5 mm. Exclusion criteria: Pregnant or lactating females Smokers (water pipe, cigar or cigarette smoking). Patients taking or have taken any drug that may cause gingival depigmentation as chloroquine, minocycline, zidovudine, chlorpromazine, ketoconazole and bleomycin . Any cause for supplemental intake of vitamin C. Reported allergy to ascorbic acid or to any of its derivatives as reported in health questionnaire . Clinically diagnosed periodontitis regarding the following criteria probing depth \>3mm, clinical attachment loss ≥ 1mm and bleeding on probing \> 10% . Patients with poor oral hygiene, incompliant to treatment and persistence gingival inflammation after phase I periodontal therapy.
Where this trial is running
Cairo
- Faculty AinShams University — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Hala K. Abd-El-Gaber, Professor — Professor of Oral Medicine, Oral Diagnosis and Periodontology Faculty of Dentistry - Ain Shams University
- Study coordinator: Eman O. Hashem, MSc
- Email: emanemmy123456@gmail.com
- Phone: 01025743781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.