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NCT Number: NCT07590375

Topical Phenytoin for Management of Gingival Recession

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.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

phenytoin cream

Drug

Phenytoin 1% paste

Placebo

Other

placebo paste

Primary outcomes

  1. Clinical Attachment loss

    Time frame: 3 months

    measured by Periodontal probe (distance from cemento-enamel junction to base of the pocket)

Secondary outcomes

  1. gingival recession

    Time frame: 3 months

    Measured by periodontal probe (distance from gingival margin to cemento-enamel junction)

  2. probing depth

    Time frame: 3 months

    Measured by periodontal probe (distance from gingival margin to base of the pocket)

  3. gingival thickness

    Time frame: 3 months

    Measured by periodontal probe (is the probe visible during probing or not? Yes/No)

  4. Keratinized tissue width

    Time frame: 3 months

    Measured by periodontal probe

  5. dentin hypersensitivity

    Time frame: 3 months

    assessed by asking the patient if they feel sensitivity as binary outcome (yeas/no) and if yes, it is assessed by VAS

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Topical Phenytoin for Management of Gingival Recession: a Randomized Placebo-controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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