Wound HealingPhase 1NCT01680042
Clinical Effect of Phenytoin Mucoadhesive Paste on Wound Healing After Oral Biopsy
A Phase 1 study testing Phenytoin paste in people with Wound Healing and Pain, run by Shahid Beheshti University of Medical Sciences at 2 sites in Iran.
Trial summary
several studies have investigated healing effect of phenytoin.In this study we investigate healing effect of phenytoin mucoadhesive paste comparing to the usual mucoadhesive paste after oral biopsy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wound Healing, Pain
- What is being tested?
- Phenytoin paste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesIran
- Study dates
- Oct 2012to Mar 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 undergone oral biopsy
Who cannot join
- systemic disease
Trial locations and contacts
2 sites in 1 country.
Iran2 sites, 2 recruiting
- Recruiting
Shaheed Beheshti University
Tehran
somayeh alirezaei, resident, 09190129151, somayeh_alirezaei_dentist@yahoo.com
somayeh alirezaei, resident
- Not yet recruiting
Shahid Beheshti Medical University
Tehran
somayeh alirezaei, DDS, 09123705943, dr.somayehalirezaei@gmail.com
somayeh alirezaei, DDS
About this study
Official title: Phase 1 Study of Phenytoin Mucoadhesive Paste for Wound Healing After Oral Biopsy
several studies have investigated healing effect of phenytoin.In this study we investigate healing effect of phenytoin mucoadhesive paste comparing to the usual mucoadhesive paste after oral biopsy.
- Conditions
- Wound Healing, Pain
- Being tested
- Phenytoin paste, Placebo
- Keywords
- inflammatory halo, VAS
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenytoin pasteDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| phenytoin paste | Active comparator | this group receives phenytoin paste after oral biopsy Receives: Drug: Phenytoin paste |
| usual mucoadhesive paste | Placebo comparator | this group receives the usual mucoadhesive paste without phenytoin after oral biopsy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing biopsy wound
patient recieves phenytoin mucoadhesive paste after oral biopsy and the diameter of inflammatory halo is determined in 1,3,5and the 7th days.pain measurment is also assesed by VAS score
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, somayeh alirezaei, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680042
- Sponsor's protocol ID
- Merck-023
- Status last verified
- Oct 2012
- First submitted
- 3 Sep 2012
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Phenytoin Mucoadhesive Paste for Wound Healing After Oral Biopsy
- ClinicalTrials.gov ID
- NCT01680042
- Acronym / sponsor ID
- Merck-023
- Conditions
- Wound Healing, Pain
- Keywords
- inflammatory halo, VAS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (estimated)
- First posted
- 6 Sep 2012 (estimated)
- 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.
several studies have investigated healing effect of phenytoin.In this study we investigate healing effect of phenytoin mucoadhesive paste comparing to the usual mucoadhesive paste after oral biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| phenytoin paste | Active comparator | Drug: Phenytoin pastethis group receives phenytoin paste after oral biopsy |
| usual mucoadhesive paste | Placebo comparator | Drug: Placebothis group receives the usual mucoadhesive paste without phenytoin after oral biopsy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergone oral biopsy
Key exclusion criteria (1 listed)
- systemic disease
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 paste | Drug | phenytoin paste |
| Placebo | Drug | usual mucoadhesive paste |
Primary outcome
healing biopsy wound
Time frame: 7 days
patient recieves phenytoin mucoadhesive paste after oral biopsy and the diameter of inflammatory halo is determined in 1,3,5and the 7th days.pain measurment is also assesed by VAS score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Phenytoin paste in people with Wound Healing and Pain, run by Shahid Beheshti University of Medical Sciences at 2 sites in Iran.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact somayeh alirezaei, DDS (09123705943, dr.somayehalirezaei@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing biopsy wound (time frame: 7 days). 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 2 Oct 2012.