Gingival Hyperpigmentation Treatment With Injectable Vitamin C in Conjunction With Glutathione Versus The Conventional Surgical Depigmentation: A Randomized Controlled Clinical Trial
| Registry | NCT07595705 |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 30 (Estimated) |
| Sponsor | Cairo University (Other); collaborators: Fayoum University |
| Conditions | Gingival Pigmentation, Depigmentation, Vitamin C, Glutathione |
| Interventions | Vitamin c and glutathione, Surgical depigmentation (Drug, procedure) |
| Dates | start 2025-08-01, primary completion 2027-01-01 (estimated), completion 2027-10-01 (estimated), first posted 2026-05-19, last updated 2026-05-19 |
| Locations | 1 site in Egypt |
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It is a clinical study conducted to evaluate the effect of vitamin C and Glucathonine injection of pigmented gingival tissue versus surgical removal by scalpel
Over the last decade, an increasing interest has been observed in esthetic treatments. In fact, The smile is an important aesthetic component of the face and significantly impacts the perception of beauty and psychological well-being. Gingival hyperpigmentation has been an aesthetic problem for many patients, which can definitely affect their psychosocial behavior.
Gingival hyperpigmentation is not a condition and can be defined as " a darker gingival color beyond what is normally expected". Moreover, it can be attributed to multiple external or internal factors. It may be physiological (excessive melanin deposition) or pathological (smoking).
Gingival Depigmentation can be treated by different modalities including chemical and surgical methods. Lately, gingival Depigmentation was carried out by lasers, cryosurgery and radiosurgery.
Additionally, multiple evidence have suggested the use of ascorbic acid (vitamin C) to treat gin- gival pigmentation. It was demonstrated that ascorbic acid is a water-soluble antioxidant and an essential nutrient for collagen biosynthesis. Furthermore, it was proven that it is effective in the elimination of hyperpigmented lesion.
Lately, glutathione has come into focus in aesthetics because of its antimelanogenic (inhibits melanosome transfer from melanocytes to keratinocytes) and antioxidant properties. It aids in skin lightening because it inhibits tyrosinase enzymes. Moreover, the use of vitamin C and glutathione has been well established, as they participate in antioxidant cellular defense systems. The series of oxidation-reduction reactions that allow vitamin C and glutathione to interact each other makes them unique The aim of the current study is to evaluate the efficacy of its rather-epidermal vitamin C in conjunction with glutathione injection compared to the conventional surgical technique in order to manage patients with gingival hyperpigmentation.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm1:(Vit C & glutathione injection) | Experimental | Drug: Vitamin c and glutathione | The site of interest will be anesthetized using topical anesthetic agent (lignocaine gel or xylocaine gel). Infiltration anesthesia will be recommended during the first injection visit. Intraepidermal injection of 1-1.5 ml of vitamin C and glutathione will be performed. It will be locally introduced in relation to the keratinized gingival tissues with extension to the whole target region successively using special syringes (50 gauge). The needle will be introduced parallel to the gingival tissues with the bevel facing upwards. Vitamin C \& glutathione will then be delivered through the attached gingival tissues at the epithelium-connective tissue junction (equivalent to epidermal- dermal junction) till the tissues blanch. Maximum 0.1 ml of injection is recommended for each point with 2-3 mm apart. The same dose will be repeated once per week for maximum 4 visits till no further color improvement gained. |
| ATM 2: surgical depigmentation | Active comparator | Procedure: Surgical depigmentation | Using a 15c blade an epithelial layer and part of connective tissue will be removed till the pigmentation disappears with ultra care not to expose the bone. The marginal and interdental papillary tissues remain critical regions, fortunately, they are not deeply pigmented. Periodontal dressing is recommended for minimal 7 days postoperative. Patients will be instructed to avoid the mechanical trauma to the treated sites. Patients will be administering an analgesic (Ibuprofen 400 mg) to be used as needed. Following each injection visit, the patients will be asked to abstain from mechanical oral hygiene procedures in relation to the target region for the day of procedure only. Plain tooth pastes (Colgate toothpaste) with anti- inflammatory mouthwash (Citrolin mouth, Pharco Company, Egypt) were recommended. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: The selection criteria were done according to Gingival pigmentation index is as follows (Dummett and Bolden)10: 1. Score0:absence of pigmentation 2. Score1:spotsofbrowntoblackcolororpigments 3. Score2:browntoblackpatchesbutnotdiffusepigmentation 4. Score3:diffuse brown to black pigmentation,marginal,and attached. Patients who have Dummett and Bolden index score 1, 2, or 3 will be included in addition to the following criteria: 1. above 18yrs 2. systemically free 3. physiologic gingival hyperpigmentation related to esthetic region 4. well maintained oral hygiene and willing to undergo minor surgical procedures Exclusion Criteria: 1. systemic diseases associated with pathological hyperpigmentation or improper delayed wound healing (uncontrolled diabetes, autoimmune diseases, etc.) 2. pregnant and lactating mothers 3. usage of chlorhexidine or povidone iodine 4. Local causes (smoking) 5. periodontal diseases (plaque and non-plaque induced gingivitis or periodontitis) 6. non compliant patients
| Facility | City | Country | Status |
|---|---|---|---|
| Faculty of Dentistry | Al Fayyum, Faiyum Governorate | Egypt | Recruiting |