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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05814003
Other study ID # HW37
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 20, 2023
Est. completion date May 20, 2023

Study information

Verified date April 2023
Source Assiut University
Contact Ahmed Mortada, professor
Phone 20 0100 543 2223
Email mortadafikry@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 .


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date May 20, 2023
Est. primary completion date May 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - insufficient zone of keratinized gingiva recession of the gingiva non smokers free from systemic disorders Exclusion Criteria: - smokers insufficient palatal donor sits un realistic expectations

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
hydroxylate flavones solid dispersion application
this drug has the antibacterial and anti inflammatory actions could help the palatal donor sites to promote the wound healing
Other:
Placebo
Dough inert material without any therapeutic action

Locations

Country Name City State
Egypt Assiut University Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

Tseng 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. — View Citation

Wyrebek 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. — View Citation

Zuhr 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary post operative pain (VAS scale) VAS scale from 0 no pain to 10 excruciating pain (healing) first day postoperative to 30 days (days)
Secondary Number of analgesic and anti inflammatory pills consumed Minimizing the pain and inflammation during healing process post operative swelling first day postoperative to 30 days (days)
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