NCT07590375

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
16mo left

Started Jun 2026

Shorter than P25 for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jun 2026Oct 2027

First Submitted

Initial submission to the registry

May 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

May 10, 2026

Last Update Submit

May 14, 2026

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

  • Clinical Attachment loss

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

    3 months

Secondary Outcomes (5)

  • gingival recession

    3 months

  • probing depth

    3 months

  • gingival thickness

    3 months

  • Keratinized tissue width

    3 months

  • dentin hypersensitivity

    3 months

Study Arms (2)

Phenytoin

ACTIVE COMPARATOR
Drug: phenytoin cream

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

phenytoin creamDRUG

Phenytoin 1% paste

Phenytoin
PlaceboOTHER

placebo paste

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients having gingival recession types RT1 and RT2
  • Patients refusing surgical treatment options of their gingival recession.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

May 10, 2026

First Posted

May 15, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

May 15, 2026

Record last verified: 2026-05