Topical Phenytoin for Management of Gingival Recession
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: phenytoin cream, Placebo.
- Who it may be relevant to
- Registry conditions: Gingival Recession. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Topical Phenytoin for Management of Gingival Recession: a Randomized Placebo-controlled Trial
Overview
Gingival recession (GR) is a term that describes the displacement of the gingival margin apical to the cemento-enamel junction (CEJ) of a tooth. The gold standard of GR treatment is surgical coverage through coronally advanced flap with subepithelial connective tissue graft (CAF+SCTG) (3). But, the need for a non-invasive technique for managing GR has not been frequently addressed. Phenytoin (PHT), used as an anti-seizure medication, has an established side effect of causing drug-influenced gingival enlargement. Its stimulatory effects on soft tissue metabolism suggested PHT to be tested topically for its effectiveness in wound healing. However, none of the previous studies that investigated topical phenytoin has assessed gingival recession; except for a case series.
Interventions
- Drug phenytoin cream
Phenytoin 1% paste - Other Placebo
placebo paste
Primary outcome measures
- Clinical Attachment loss [Time frame: 3 months]
Secondary outcome measures (5)
- gingival recession [Time frame: 3 months]
- probing depth [Time frame: 3 months]
- gingival thickness [Time frame: 3 months]
- Keratinized tissue width [Time frame: 3 months]
- dentin hypersensitivity [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- Patients having gingival recession types RT1 and RT2
- Patients refusing surgical treatment options of their gingival recession.
Exclusion criteria
- Patients who underwent periodontal surgery in the affected teeth.
- Patients with sensitivity to the medication used in the study.
- Patients with systemic problems or administering drugs which could affect their periodontium or healing.
- Pregnant or lactating women.
- Smoking patients.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07590375 · ACU-Per4