Gingival RecessionPhase 2/3NCT07590375
Topical Phenytoin for Management of Gingival Recession
A Phase 2/3 study testing phenytoin cream in people with Gingival Recession, run by Cairo University.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gingival Recession
- What is being tested?
- phenytoin cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to Oct 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients having gingival recession types RT1 and RT2
- Patients refusing surgical treatment options of their gingival recession.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Gingival Recession
- Being tested
- phenytoin cream, Placebo
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phenytoin creamDrug
Phenytoin 1% paste
PlaceboOther
placebo paste
| Study group | Role | What they receive |
|---|---|---|
| Phenytoin | Active comparator | Not described Receives: Drug: phenytoin cream |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment loss
measured by Periodontal probe (distance from cemento-enamel junction to base of the pocket)
Measured: 3 months
Secondary outcomes (5)
gingival recession
Measured by periodontal probe (distance from gingival margin to cemento-enamel junction)
Measured: 3 months
probing depth
Measured by periodontal probe (distance from gingival margin to base of the pocket)
Measured: 3 months
gingival thickness
Measured by periodontal probe (is the probe visible during probing or not? Yes/No)
Measured: 3 months
Keratinized tissue width
Measured by periodontal probe
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayat Gamal-AbdelNaser, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590375
- Sponsor's protocol ID
- ACU-Per4
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Phenytoin for Management of Gingival Recession: a Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07590375
- Acronym / sponsor ID
- ACU-Per4
- Conditions
- Gingival Recession
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenytoin | Active comparator | Drug: phenytoin cream |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients having gingival recession types RT1 and RT2
- Patients refusing surgical treatment options of their gingival recession.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phenytoin creamPhenytoin 1% paste | Drug | Phenytoin |
| Placeboplacebo paste | Other | Placebo |
Primary outcome
Clinical Attachment loss
Time frame: 3 months
measured by Periodontal probe (distance from cemento-enamel junction to base of the pocket)
5 secondary outcomes
gingival recession
Time frame: 3 months
probing depth
Time frame: 3 months
gingival thickness
Time frame: 3 months
Keratinized tissue width
Time frame: 3 months
dentin hypersensitivity
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Undecided
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Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
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i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
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Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
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Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
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Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing phenytoin cream in people with Gingival Recession, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Attachment loss (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.