Health TrialsbyHealthPanel

Topical Phenytoin for Management of Gingival Recession

ConditionGingival Recession
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCairo University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients having gingival recession types RT1 and RT2

Patients refusing surgical treatment options of their gingival recession.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • phenytoin cream

    Drug

    Phenytoin 1% paste

  • Placebo

    Other intervention

    placebo paste

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: PhenytoinActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical Attachment loss

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

Time frame
3 months

Secondary outcomes

1

gingival recession

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

Time frame
3 months
2

probing depth

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

Time frame
3 months
3

gingival thickness

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

Time frame
3 months
4

Keratinized tissue width

Measured by periodontal probe

Time frame
3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: