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Topical Phenytoin for Management of Gingival Recession

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

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07590375
Enrollment
30
Registered
2026-05-15
Start date
2026-06-01
Completion date
2027-10-01
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession

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.

Interventions

Phenytoin 1% paste

OTHERPlacebo

placebo paste

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical Attachment loss3 monthsmeasured by Periodontal probe (distance from cemento-enamel junction to base of the pocket)

Secondary

MeasureTime frameDescription
gingival recession3 monthsMeasured by periodontal probe (distance from gingival margin to cemento-enamel junction)
probing depth3 monthsMeasured by periodontal probe (distance from gingival margin to base of the pocket)
gingival thickness3 monthsMeasured by periodontal probe (is the probe visible during probing or not? Yes/No)
Keratinized tissue width3 monthsMeasured by periodontal probe
dentin hypersensitivity3 monthsassessed by asking the patient if they feel sensitivity as binary outcome (yeas/no) and if yes, it is assessed by VAS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026