- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04990999
Vestibular Extraction Technique (VET): a Novel Atraumatic Extraction Technique
August 3, 2021 updated by: Hams Hamed Abdelrahman
Vestibular Extraction Technique (VET): a Novel Atraumatic Extraction Technique (Randomized Clinical Trial)
study proposes an alternative atraumatic tooth extraction procedure; Apically achieved exodontia, which might offer an alternative to the conventional incisal exodontia, whilst providing minimum tissue trauma and subsequently maximum marginal tissue preservation.
Study Overview
Status
Completed
Conditions
Detailed Description
A sample of 26 patients that received the extraction therapy For Group (A) patients, Atraumatic extractions using periotomes followed by conventional forceps were performed.
For Group (B) patients, the novel technique of Vestibular Root Extraction was performed to the sample group's hopeless teeth.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Alexandria, Egypt
- Private Practice Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Single non-adjacent hopeless maxillary anterior teeth
- Type II socket)
- Intact overlying soft tissues.
- Adequate palatal and at least 3 mm apical bone
Exclusion Criteria:
- Smokers
- Pregnant females
- Patients with systemic diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vestibular Root Extraction
|
a 1-cm long vestibular access incision was cut, 3-4 mm apical to the mucogingival junction of the involved tooth, then pushing the vestibular pouch in an incisal direction exposing the apical root area, and allowing direct undisturbed access to the root surface
|
|
Active Comparator: Atraumatic extractions using periotomes followed by conventional forceps
|
a sulcular releasing incision suing a micro scalpel was made to detach the surrounding tissues, followed by applying the periotome interproximally into the PDL space, widening the attached periodontal ligaments space.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in post restorative soft tissue height
Time Frame: at baseline and 12 months
|
identified midfacially and at the apex of the mesial and distal papillae by superimposing the STL (Standard Triangle Language) files of the models, obtained via IOS
|
at baseline and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Actual)
February 1, 2021
Study Completion (Actual)
February 1, 2021
Study Registration Dates
First Submitted
July 26, 2021
First Submitted That Met QC Criteria
August 3, 2021
First Posted (Actual)
August 5, 2021
Study Record Updates
Last Update Posted (Actual)
August 5, 2021
Last Update Submitted That Met QC Criteria
August 3, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- vestibular extraction 2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.