NCT06220877

Brief Summary

Evaluation of the efficacy of different treatment protocols in the management of Oro-Antral Communications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

4 years

First QC Date

January 13, 2024

Last Update Submit

January 13, 2024

Conditions

Healthy Volunteers Only

Keywords

Benacel;bone regeneration;platelet rich growth factor;Oro-Antral Communicationbuccal pad of fatfibrin glue

Outcome Measures

Primary Outcomes (1)

  • o Recurrence

    presence or absence

    6 months

Secondary Outcomes (1)

  • pain, visual analog scale

    4 weeks

Study Arms (4)

Group I

ACTIVE COMPARATOR

patients were treated using Buccal Pad of Fat for management of OAC.

Procedure: Buccal Pad of Fat

Group II

ACTIVE COMPARATOR

patients were treated using A-PRF technique for management of OAC.

Procedure: A-PRF

Group III

ACTIVE COMPARATOR

patients were treated with Fibrin Glue for management of OAC.

Procedure: fibrin glue

Group IV

ACTIVE COMPARATOR

oxidized regenerated cellulose plug have been used for management of OAC.

Procedure: oxidized cellulose

Interventions

Buccal Pad of FatPROCEDURE

surgical procedure

Group I
A-PRFPROCEDURE

blood sample

Group II
fibrin gluePROCEDURE

procedure

Group III
oxidized cellulosePROCEDURE

procedure

Group IV

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients suffering from oroantral communications
  • patients suffering from oroantral fistula.
  • The Diameter of the opening ranged from 4-9 mm,
  • communication resulted from recent extraction,
  • foreign body; or
  • cyst enucleation

You may not qualify if:

  • Patients suffering from any systemic diseases were excluded from the study.
  • diabetes,
  • autoimmune diseases,
  • cancers,
  • nephropathy,
  • coagulation disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6U

Cairo, 12566, Egypt

Location

MeSH Terms

Conditions

Oroantral Fistula

Interventions

Fibrin Tissue AdhesiveCellulose, Oxidized

Condition Hierarchy (Ancestors)

Oral FistulaMouth DiseasesStomatognathic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsCelluloseGlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydrates

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 oral and maxillofacial surgery

Study Record Dates

First Submitted

January 13, 2024

First Posted

January 24, 2024

Study Start

January 1, 2019

Primary Completion

January 1, 2023

Study Completion

June 1, 2023

Last Updated

January 24, 2024

Record last verified: 2024-01

Locations

EG(1)