Wound HealingPhase 1NCT05334745
Clinical Comparison of Topical Application of Alvogyl Versus Hyaluronic-Acid Gel in Management of Pain And Palatal Wound Healing
A Phase 1 study testing Alvogyl in people with Wound Healing, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the effect of application of Alvogyl versus hyaluronic acid in decreasing postoperative pain and promoting healing in the palatal wound following the free gingival graft procedure Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Healing
- What is being tested?
- Alvogyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 1 Jan 2023
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with mucogingival defects scheduled for free gingival graft
- Age from 18 years up to 60
- Medically healthy patient
Who cannot join
- Systemic diseases that may be a contraindication for any surgeries.
- Loss of maxillary premolars and molars.
- Pregnancy or lactation
- Smoking
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Egypt
Cairo, 11865
mohyeldin aboelazayem, TA, +201005007001, mohy.aboelazayem@dentistry.cu.edu.eg
shaimaa nasr, PHD, +201272789994, dr.shaimaanasr@gmail.com
About this study
Official title: Clinical Comparison of Topical Application of Alvogyl Versus Topical Application of Hyaluronic-Acid Gel in Management of Pain And Palatal Wound Healing : A Randomized Controlled Clinical Trial
The aim of the study is to evaluate the effect of application of Alvogyl versus hyaluronic acid in decreasing postoperative pain and promoting healing in the palatal wound following the free gingival graft procedure
Read the detailed description
Postoperative pain and bleeding are the most common complications after palatal graft harvesting, also postsurgical swelling have been reported. Although hemostatic agents, mechanical barriers, bioactive materials, antibacterial and antiseptic agents and herbal products have been found effective in preventing such complications, an ideal support could not be specified for this purpose. Further, undesired side effects such as delayed wound healing/foreign body reaction have been reported .
No gold standard has been identified, thus there is a need for further investigations aiming to reach the best possible treatment modality for pain relief and prevention of reported complications following harvesting of palatal graft .
- Conditions
- Wound Healing
- Being tested
- Alvogyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlvogylOther
Also called Hyaluronic acid
application of Alvogyl in the palatal wound with stent versus hyaluronic acid application
| Study group | Role | What they receive |
|---|---|---|
| application of Alvogyl in the palatal wound with stent | Experimental | Not described Receives: Other: Alvogyl |
| application of 0.2% Hyaluronic acid is placed in the palatal wound with stent . | Other | Not described Receives: Other: Alvogyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Pain through one week using the visual analogue scale (VAS)
Measured: 7th days
Secondary outcomes (1)
Wound healing
- Wound healing index through one month .
- The healing index has 5 grades which are 5(excellent healing), 4(very good healing), 3 (good healing), 2(poor healing) and 1(very poor healing)
Measured: 7th, 14th, 21st and 30th days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Dec 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jan 2023 (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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohy eldin mahmoud aboelazayem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334745
- Sponsor's protocol ID
- 01005007001
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Topical Application of Alvogyl Versus Topical Application of Hyaluronic-Acid Gel in Management of Pain And Palatal Wound Healing : A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05334745
- Acronym / sponsor ID
- 01005007001
- Conditions
- Wound Healing
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 19 Apr 2022 (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.
The aim of the study is to evaluate the effect of application of Alvogyl versus hyaluronic acid in decreasing postoperative pain and promoting healing in the palatal wound following the free gingival graft procedure
Detailed description
Postoperative pain and bleeding are the most common complications after palatal graft harvesting, also postsurgical swelling have been reported. Although hemostatic agents, mechanical barriers, bioactive materials, antibacterial and antiseptic agents and herbal products have been found effective in preventing such complications, an ideal support could not be specified for this purpose. Further, undesired side effects such as delayed wound healing/foreign body reaction have been reported .
No gold standard has been identified, thus there is a need for further investigations aiming to reach the best possible treatment modality for pain relief and prevention of reported complications following harvesting of palatal graft .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| application of Alvogyl in the palatal wound with stent | Experimental | Other: Alvogyl |
| application of 0.2% Hyaluronic acid is placed in the palatal wound with stent . | Other | Other: Alvogyl |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with mucogingival defects scheduled for free gingival graft
- Age from 18 years up to 60
- Medically healthy patient
Key exclusion criteria (4 listed)
- Systemic diseases that may be a contraindication for any surgeries.
- Loss of maxillary premolars and molars.
- Pregnancy or lactation
- Smoking
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 |
|---|---|---|
| AlvogylAlso: Hyaluronic acidapplication of Alvogyl in the palatal wound with stent versus hyaluronic acid application | Other | application of 0.2% Hyaluronic acid is placed in the palatal wound with stent ., application of Alvogyl in the palatal wound with stent |
Primary outcome
postoperative pain
Time frame: 7th days
Pain through one week using the visual analogue scale (VAS)
1 secondary outcome
Wound healing
Time frame: 7th, 14th, 21st and 30th days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alvogyl in people with Wound Healing, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 4 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 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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. 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 mohy eldin aboelazayem, TA (+201005007001, mohy.aboelazayem@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: 7th 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 19 Apr 2022.