NCT05814003

Brief 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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

April 20, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2023

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

1 month

First QC Date

October 10, 2022

Last Update Submit

April 13, 2023

Conditions

Soft Tissue InfectionsGingival Recession

Outcome Measures

Primary Outcomes (1)

  • post operative pain (VAS scale)

    VAS scale from 0 no pain to 10 excruciating pain (healing)

    first day postoperative to 30 days (days)

Secondary Outcomes (1)

  • Number of analgesic and anti inflammatory pills consumed

    first day postoperative to 30 days (days)

Study Arms (3)

hydroxylate flavones

EXPERIMENTAL

flavonoids mainly derived from citrus peel and have numerous strong biological activities, including anti-inflammatory , antioxidant , antimicrobial , and anticancer

Drug: hydroxylate flavones solid dispersion applicationOther: 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.

Drug: hydroxylate flavones solid dispersion applicationOther: Placebo

stent

PLACEBO COMPARATOR

acrylic resin material used to cover denuded soft tissues

Drug: hydroxylate flavones solid dispersion application

Interventions

hydroxylate flavones solid dispersion applicationDRUG

this drug has the antibacterial and anti inflammatory actions could help the palatal donor sites to promote the wound healing

Also known as: Natural therapy without side effects
alveogylhydroxylate flavonesstent
PlaceboOTHER

Dough inert material without any therapeutic action

alveogylhydroxylate flavones

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • insufficient zone of keratinized gingiva recession of the gingiva non smokers free from systemic disorders

You may not qualify if:

  • smokers insufficient palatal donor sits un realistic expectations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related 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.

    PMID: 30794264BACKGROUND

  • 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.

    PMID: 24640997BACKGROUND

  • 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.

    PMID: 30152618BACKGROUND

  • 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.

    PMID: 32559041BACKGROUND

MeSH Terms

Conditions

Soft Tissue InfectionsGingival Recession

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Ahmed Mortada, Professor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Mortada, professor

CONTACT

20 0100 543 2223mortadafikry@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor - faculty of dentistry

Study Record Dates

First Submitted

October 10, 2022

First Posted

April 14, 2023

Study Start

April 20, 2023

Primary Completion

May 20, 2023

Study Completion

May 20, 2023

Last Updated

April 14, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)