Soft Tissue InfectionsRCTNCT05814003
Clinical Effectiveness of Polymethoxy Flavones Solid Dispersion as a Dressing Material for Palatal Grafts Donor Sites
A study testing hydroxylate flavones solid dispersion application in people with Soft Tissue Infections and Gingival Recession, run by Assiut University at 1 site in Egypt.
Trial summary
Free gingival grafting surgeries require palatal grafts harvesting from the patient own palates . The donor sites pain , infection and retarded healing by secondary intension are the complication . Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Infections, Gingival Recession
- What is being tested?
- hydroxylate flavones solid dispersion application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2023to 20 May 2023
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- insufficient zone of keratinized gingiva recession of the gingiva non smokers free from systemic disorders
Who cannot join
- smokers insufficient palatal donor sits un realistic expectations
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut University
Asyut
ahmed fikry, 01005432223 ext. 002, mortadafikry@hotmail.com
About this study
Official title: The Clinical Effectiveness of Hydroxylated Polymethoxy Flavones Solid Dispersion as a Dressing Material for Palatal Graft Donor Sites
Free gingival grafting surgeries require palatal grafts harvesting from the patient own palates . The donor sites pain , infection and retarded healing by secondary intension are the complication .
Read the detailed description
After the preparation and characterization of the solid dispersion of hydroxylated methoxy flavones, free gingival grafting surgeries require palatal grafts harvesting from the patient own palates . The donor sites pain , infection and retarded healing by secondary intension are the complications ; the aim of the study is to assess the analgesic , anti inflammatory effects of hydroxylated methoxy flavones.
- Conditions
- Soft Tissue Infections, Gingival Recession
- Being tested
- hydroxylate flavones solid dispersion application, Placebo
- Medical subject headings
- Soft Tissue Infections, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydroxylate flavones solid dispersion applicationDrug
Also called Natural therapy without side effects
this drug has the antibacterial and anti inflammatory actions could help the palatal donor sites to promote the wound healing
PlaceboOther
Dough inert material without any therapeutic action
| Study group | Role | What they receive |
|---|---|---|
| hydroxylate flavones | Experimental | flavonoids mainly derived from citrus peel and have numerous strong biological activities, including anti-inflammatory , antioxidant , antimicrobial , and anticancer Receives: Drug: hydroxylate flavones solid dispersion application; Other: Placebo |
| alveogyl | Active comparator | ALVOGYL is a brown fibrous paste which contains per 100 g the following active ingredients : 25.70 g of butamben, 15.80 g of iodoform and 13.70 g of eugenol. Receives: Drug: hydroxylate flavones solid dispersion application; Other: Placebo |
| stent | Placebo comparator | acrylic resin material used to cover denuded soft tissues Receives: Drug: hydroxylate flavones solid dispersion application |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain (VAS scale)
VAS scale from 0 no pain to 10 excruciating pain (healing)
Measured: first day postoperative to 30 days (days)
Secondary outcomes (1)
Number of analgesic and anti inflammatory pills consumed
Minimizing the pain and inflammation during healing process post operative swelling
Measured: first day postoperative to 30 days (days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start20 Apr 2023 (estimated)
- Primary completion20 May 2023 (estimated)
- Study completion20 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue InfectionsStudies of the same condition, open and under way.
- More trials run by Assiut 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mortada, Assiut University
- Investigators
- Ahmed Mortada, Professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814003
- Sponsor's protocol ID
- HW37
- Acronym
- RCT
- Status last verified
- Apr 2023
- First submitted
- 10 Oct 2022
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paolantonio M, De Ninis P, Secondi L, Femminella B. The Full-Thickness Palatal Graft Technique: Description of an Original Surgical Technique and 15 Case Reports. Int J Periodontics Restorative Dent. 2019 Mar/Apr;39(2):267-277. doi: 10.11607/prd.3741.
PubMed 30794264Zuhr O, Baumer D, Hurzeler M. The addition of soft tissue replacement grafts in plastic periodontal and implant surgery: critical elements in design and execution. J Clin Periodontol. 2014 Apr;41 Suppl 15:S123-42. doi: 10.1111/jcpe.12185.
PubMed 24640997Wyrebek B, Gorski B, Gorska R. Patient morbidity at the palatal donor site depending on gingival graft dimension. Dent Med Probl. 2018 Apr-Jun;55(2):153-159. doi: 10.17219/dmp/91406.
PubMed 30152618Tseng ES, Tavelli L, Wang HL. Palatal Pedicle Flaps for Soft Tissue Augmentation. Int J Periodontics Restorative Dent. 2020 Jul/Aug;40(4):581-588. doi: 10.11607/prd.4561.
PubMed 32559041
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effectiveness of Hydroxylated Polymethoxy Flavones Solid Dispersion as a Dressing Material for Palatal Graft Donor Sites
- ClinicalTrials.gov ID
- NCT05814003
- Acronym / sponsor ID
- RCT / HW37
- Conditions
- Soft Tissue Infections, Gingival Recession
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Apr 2023 (estimated)
- Primary completion
- 20 May 2023 (estimated)
- Study completion
- 20 May 2023 (estimated)
- First posted
- 14 Apr 2023 (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.
Free gingival grafting surgeries require palatal grafts harvesting from the patient own palates . The donor sites pain , infection and retarded healing by secondary intension are the complication .
Detailed description
After the preparation and characterization of the solid dispersion of hydroxylated methoxy flavones, free gingival grafting surgeries require palatal grafts harvesting from the patient own palates . The donor sites pain , infection and retarded healing by secondary intension are the complications ; the aim of the study is to assess the analgesic , anti inflammatory effects of hydroxylated methoxy flavones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hydroxylate flavones | Experimental | Drug: hydroxylate flavones solid dispersion application, Other: Placeboflavonoids mainly derived from citrus peel and have numerous strong biological activities, including anti-inflammatory , antioxidant , antimicrobial , and anticancer |
| alveogyl | Active comparator | Drug: hydroxylate flavones solid dispersion application, Other: PlaceboALVOGYL is a brown fibrous paste which contains per 100 g the following active ingredients : 25.70 g of butamben, 15.80 g of iodoform and 13.70 g of eugenol. |
| stent | Placebo comparator | Drug: hydroxylate flavones solid dispersion applicationacrylic resin material used to cover denuded soft tissues |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- insufficient zone of keratinized gingiva recession of the gingiva non smokers free from systemic disorders
Key exclusion criteria (1 listed)
- smokers insufficient palatal donor sits un realistic expectations
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 |
|---|---|---|
| hydroxylate flavones solid dispersion applicationAlso: Natural therapy without side effectsthis drug has the antibacterial and anti inflammatory actions could help the palatal donor sites to promote the wound healing | Drug | alveogyl, hydroxylate flavones, stent |
| PlaceboDough inert material without any therapeutic action | Other | alveogyl, hydroxylate flavones |
Primary outcome
post operative pain (VAS scale)
Time frame: first day postoperative to 30 days (days)
VAS scale from 0 no pain to 10 excruciating pain (healing)
1 secondary outcome
Number of analgesic and anti inflammatory pills consumed
Time frame: first day postoperative to 30 days (days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Background: PubMed 30794264Paolantonio M, De Ninis P, Secondi L, Femminella B. The Full-Thickness Palatal Graft Technique: Description of an Original Surgical Technique and 15 Case Reports. Int J Periodontics Restorative Dent. 2019 Mar/Apr;39(2):267-277. doi: 10.11607/prd.3741.
- Background: PubMed 24640997Zuhr O, Baumer D, Hurzeler M. The addition of soft tissue replacement grafts in plastic periodontal and implant surgery: critical elements in design and execution. J Clin Periodontol. 2014 Apr;41 Suppl 15:S123-42. doi: 10.1111/jcpe.12185.
- Background: PubMed 30152618Wyrebek B, Gorski B, Gorska R. Patient morbidity at the palatal donor site depending on gingival graft dimension. Dent Med Probl. 2018 Apr-Jun;55(2):153-159. doi: 10.17219/dmp/91406.
- Background: PubMed 32559041Tseng ES, Tavelli L, Wang HL. Palatal Pedicle Flaps for Soft Tissue Augmentation. Int J Periodontics Restorative Dent. 2020 Jul/Aug;40(4):581-588. doi: 10.11607/prd.4561.
- Individual participant dataSharing planned: No
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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.
Ahmed Mortada, Professor principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydroxylate flavones solid dispersion application in people with Soft Tissue Infections and Gingival Recession, run by Assiut 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 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 14 Apr 2023. 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. 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.
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 Ahmed Mortada, professor (20 0100 543 2223, mortadafikry@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative pain (VAS scale) (time frame: first day postoperative to 30 days (days)). 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 NCT05814003, which also lists 4 linked publications.
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 14 Apr 2023.