Actively Recruiting
Gingival Hyperpigmentation Treatment With Injectable Vitamin C and Glutathione Versus Conventional Surgical Depigmentation: A Randomized Controlled Clinical Trial
Led by Cairo University · Updated on 2026-05-19
30
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
C
Cairo University
Lead Sponsor
F
Fayoum University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of injectable vitamin C with glutathione compared to surgical removal by scalpel for treating gingival hyperpigmentation, an aesthetic concern caused by excessive melanin or other factors. The study addresses how this pigmentation affects patients' smiles and psychological well-being, aiming to find an effective treatment to manage this condition. The study involves two groups: one receiving weekly intraepidermal injections of vitamin C and glutathione in the gingival tissues for up to four visits, and the other undergoing surgical depigmentation where pigmented gingival layers are removed using a scalpel. Anesthesia is applied before treatments, and post-procedure care includes avoiding trauma and using pain relief and mouthwash for surgical patients. Participants will be monitored over nine months, with assessments of pigmentation using specific indices and digital photos at baseline and several follow-up points. Additional measures include pain and itching scores after treatments and patient satisfaction at the study's end. The trial includes regular evaluations to track treatment effects and safety, lasting from the first day through 9 months post-procedure.
CONDITIONS
Brief Title
Gingival Hyperpigmentation Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Gingival pigmentation score of 1, 2, or 3 on the Dummett and Bolden index
- Systemically healthy individuals
- Physiologic gingival hyperpigmentation in the aesthetic region
- Good oral hygiene and willingness to undergo minor surgical procedures
You will not qualify if you...
- Systemic diseases causing pathological hyperpigmentation or delayed wound healing (e.g., uncontrolled diabetes, autoimmune diseases)
- Pregnant or lactating women
- Use of chlorhexidine or povidone iodine products
- Local causes such as smoking
- Presence of periodontal diseases (gingivitis or periodontitis)
- Patients who are non-compliant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants receive either intraepidermal injections of vitamin C and glutathione once per week for up to 4 weeks or undergo surgical depigmentation to remove gingival pigmentation.
Up to 4 weekly visits for injections or 1 surgical procedure with postoperative care
Duration - 9 months
Participants are monitored for pain, itching, gingival pigmentation, and satisfaction for up to 9 months after treatment.
Visits at 1 month, 3 months, 6 months, and 9 months post-treatment
Trial Site Locations
Total: 1 location
1
Faculty of Dentistry
Al Fayyum, Faiyum Governorate, Egypt, 63511
Actively Recruiting
Research Team
N
Nourhan A Abdelkhalek
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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