NCT04499144

Brief Summary

The aim of this study is to describe a modified surgical approach for the closure of oral sinus communications, using a buccal trapezoidal flap combined with a connective pedicle flap rotated from the palate

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 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

June 26, 2020

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2020

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
Last Updated

August 10, 2020

Status Verified

August 1, 2020

Enrollment Period

3 days

First QC Date

July 30, 2020

Last Update Submit

August 6, 2020

Conditions

Surgery Site Fistula

Keywords

ExtractionOro-antral communicationOro-antral fistula

Outcome Measures

Primary Outcomes (1)

  • Closure of the communication

    Clinical observation

    Day 30

Secondary Outcomes (1)

  • Pain and discomfort

    Day 30

Study Arms (1)

modified buccal flap and subepithelial connective palatal flap

EXPERIMENTAL
Procedure: modified buccal flap and subepithelial connective palatal flap

Interventions

modified buccal flap and subepithelial connective palatal flapPROCEDURE

The connective flap was harvested from the deeper area of the palatal mucosa. Pedicle flap dimensions were reported using the periodontal probe. The flap was then rotated to cover the oro antral communication (OAC) area. The rotation could be in mesial or distal direction, related to OAC position and for the convenience of the donor site. The connective palatal flap was sutured to the buccal periostium using mattress sutures.

modified buccal flap and subepithelial connective palatal flap

Eligibility Criteria

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

You may qualify if:

  • Patient with diagnosis of Oro-antral communication
  • Patients with adequate radiographic status
  • Patients who read and signed the informed consent
  • Patients without periodontal disease
  • Patients≥18

You may not qualify if:

  • Pregnancy or breastfeeding patients
  • Patients compliance and patients with mental disorders
  • Patients with diabetes
  • Patients with osteonecrosis
  • Patients with head and neck cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Siena- Department of medical biotechnologies

Siena, 53100, Italy

Location

MeSH Terms

Conditions

Oroantral Fistula

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ralph Habib, Dr.

    University of Siena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: case series of a new surgical design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 30, 2020

First Posted

August 5, 2020

Study Start

June 26, 2020

Primary Completion

June 29, 2020

Study Completion

July 27, 2020

Last Updated

August 10, 2020

Record last verified: 2020-08

Locations

IT(1)