Topical Phenytoin for Management of Gingival Recession

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gingival Recession
• Intervention / Treatment: Drug: phenytoin cream; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; placebo paste
Active Comparator: Phenytoin	Drug: phenytoin cream; Phenytoin 1% paste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Attachment loss	measured by Periodontal probe (distance from cemento-enamel junction to base of the pocket)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gingival recession	Measured by periodontal probe (distance from gingival margin to cemento-enamel junction)	3 months
probing depth	Measured by periodontal probe (distance from gingival margin to base of the pocket)	3 months
gingival thickness	Measured by periodontal probe (is the probe visible during probing or not? Yes/No)	3 months
Keratinized tissue width	Measured by periodontal probe	3 months
dentin hypersensitivity	assessed by asking the patient if they feel sensitivity as binary outcome (yeas/no) and if yes, it is assessed by VAS	3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: May 10, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Gingival Recession
• Other Study ID Numbers: ACU-Per4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No