Pain, ProceduralPhase 4NCT03402321
Alveogyl and Gelatin Sponge in the Management of Pain After Epithelialized Free Gingival Graft Harvesting
A Phase 4 study testing Gelatin Sponge Sheet and Alvogyl in people with Pain, Procedural, run by Karim ehab gerges.
Trial summary
clinical comparison between alvogyl and gelatin sponge when used to protect the denuded area of the palatal donor site after free gingival graft in means of reducing pain and healing. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain, Procedural
- What is being tested?
- Gelatin Sponge Sheet and Alvogyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 1 Jul 2019
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients scheduled for different periodontal and peri-implant plastic surgeries requiring palatal mucosal graft harvesting
- Systemically healthy
Who cannot join
- Severe gagging reflex
- Smokers
- Occlusal trauma at site of graft
- Pregnancy
- Psychiatric disorder
- Patients allergic to the used agents
About this study
Official title: Clinical Comparison of Alveogyl and Gelatin Sponge in the Management of Pain After Epithelialized Free Gingival Graft Harvesting: A Randomized Clinical Trial
clinical comparison between alvogyl and gelatin sponge when used to protect the denuded area of the palatal donor site after free gingival graft in means of reducing pain and healing.
- Conditions
- Pain, Procedural
- Being tested
- Gelatin Sponge Sheet, Alvogyl
- Keywords
- alveogyl, gelatin sponge, free gingival graft, palate, pain
- Medical subject headings
- Pain, Procedural, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelatin Sponge SheetDrug
Also called gel foam
sheets act as a mechanical barrier used to protect the denuded area of the palatal donor site
AlvogylDrug
Also called Alveogyl
paste form with analgesic action to protect the palatal donor site and help to relief pain
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Gelatin Sponge Sheet is a heamostatic agent act as a mechanical barrier to protect the palatal donor site Receives: Drug: Gelatin Sponge Sheet |
| intervention group | Experimental | alvogyl in a paste form with analgesic action to protect the palatal donor site and help to relief pain Receives: Drug: Alvogyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
recorded by the pain trough a Visual Analogue scale score (between 0 and 10. 0: no pain, 1: minimal pain,10: severe pain)
Measured: 2 weeks
Secondary outcomes (3)
healing
healing of the palatal mucosa using H2O2 Test this test is based on the principle that if the epithelium is discontinuous, then H2O2 diffuses into the CT, the enzyme catalase acts on H2O2to release water and oxygen. This is shown clinically by the production of bubbles on the wound. The area to be evaluated is then dried, and 3% H2O2 is sprinkled on the wound with a syringe, waiting for the appearance of bubbles, which will suggest that the surgical site is not completely epithelialized. Complete healing will be recorded as a dichotomous variable (yes/no).
Measured: 4 weeks
bleeding
Questionaire, Binary (yes or no).
Measured: 2 weeks
analgesic consumption
questionaure, Numerical, Amount of analgesics daily consumption
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start1 Apr 2019 (estimated)
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, ProceduralStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karim ehab gerges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karim ehab gerges, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402321
- Sponsor's protocol ID
- 1792013
- Status last verified
- Feb 2019
- First submitted
- 27 Dec 2017
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ehab K, Abouldahab O, Hassan A, Fawzy El-Sayed KM. Alvogyl and absorbable gelatin sponge as palatal wound dressings following epithelialized free gingival graft harvest: a randomized clinical trial. Clin Oral Investig. 2020 Apr;24(4):1517-1525. doi: 10.1007/s00784-020-03254-z. Epub 2020 Mar 6.
PubMed 32144515
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Alveogyl and Gelatin Sponge in the Management of Pain After Epithelialized Free Gingival Graft Harvesting: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03402321
- Acronym / sponsor ID
- 1792013
- Conditions
- Pain, Procedural
- Keywords
- alveogyl, gelatin sponge, free gingival graft, palate, pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Karim ehab gergesUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 18 Jan 2018 (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.
clinical comparison between alvogyl and gelatin sponge when used to protect the denuded area of the palatal donor site after free gingival graft in means of reducing pain and healing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: Gelatin Sponge SheetGelatin Sponge Sheet is a heamostatic agent act as a mechanical barrier to protect the palatal donor site |
| intervention group | Experimental | Drug: Alvogylalvogyl in a paste form with analgesic action to protect the palatal donor site and help to relief pain |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for different periodontal and peri-implant plastic surgeries requiring palatal mucosal graft harvesting
- Systemically healthy
Key exclusion criteria (6 listed)
- Severe gagging reflex
- Smokers
- Occlusal trauma at site of graft
- Pregnancy
- Psychiatric disorder
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 |
|---|---|---|
| Gelatin Sponge SheetAlso: gel foamsheets act as a mechanical barrier used to protect the denuded area of the palatal donor site | Drug | control group |
| AlvogylAlso: Alveogylpaste form with analgesic action to protect the palatal donor site and help to relief pain | Drug | intervention group |
Primary outcome
pain score
Time frame: 2 weeks
recorded by the pain trough a Visual Analogue scale score (between 0 and 10. 0: no pain, 1: minimal pain,10: severe pain)
3 secondary outcomes
healing
Time frame: 4 weeks
bleeding
Time frame: 2 weeks
analgesic consumption
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Derived from this study: PubMed 32144515Ehab K, Abouldahab O, Hassan A, Fawzy El-Sayed KM. Alvogyl and absorbable gelatin sponge as palatal wound dressings following epithelialized free gingival graft harvest: a randomized clinical trial. Clin Oral Investig. 2020 Apr;24(4):1517-1525. doi: 10.1007/s00784-020-03254-z. Epub 2020 Mar 6.
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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.
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 4 study testing Gelatin Sponge Sheet and Alvogyl in people with Pain, Procedural, run by Karim ehab gerges.
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 6 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 8 Feb 2019. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
pain score (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03402321, which also lists 1 linked publication.
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 8 Feb 2019.