Tooth ExtractionNCT04990999
Vestibular Extraction Technique (VET): a Novel Atraumatic Extraction Technique
A study testing Vestibular Root Extraction and Atraumatic extractions using periotomes followed by conventional forceps in people with Tooth Extraction, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Extraction
- What is being tested?
- Vestibular Root Extraction and Atraumatic extractions using periotomes followed by conventional forceps
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single non-adjacent hopeless maxillary anterior teeth
- Type II socket)
- Intact overlying soft tissues.
- Adequate palatal and at least 3 mm apical bone
Who cannot join
- Smokers
- Pregnant females
- Patients with systemic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tooth Extraction
- Being tested
- Vestibular Root Extraction, Atraumatic extractions using periotomes followed by conventional forceps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Root ExtractionProcedure or surgery
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
Atraumatic extractions using periotomes followed by conventional forcepsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Root Extraction | Experimental | Not described Receives: Procedure: Vestibular Root Extraction |
| Atraumatic extractions using periotomes followed by conventional forceps | Active comparator | Not described Receives: Procedure: Atraumatic extractions using periotomes followed by conventional forceps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in post restorative soft tissue height
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
Measured: at baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Apr 2019
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990999
- Sponsor's protocol ID
- vestibular extraction 2021
- Status last verified
- Aug 2021
- First submitted
- 26 Jul 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Extraction Technique (VET): a Novel Atraumatic Extraction Technique (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04990999
- Acronym / sponsor ID
- vestibular extraction 2021
- Conditions
- Tooth Extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular Root Extraction | Experimental | Procedure: Vestibular Root Extraction |
| Atraumatic extractions using periotomes followed by conventional forceps | Active comparator | Procedure: Atraumatic extractions using periotomes followed by conventional forceps |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Single non-adjacent hopeless maxillary anterior teeth
- Type II socket)
- Intact overlying soft tissues.
- Adequate palatal and at least 3 mm apical bone
Key exclusion criteria (3 listed)
- Smokers
- Pregnant females
- Patients with systemic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular Root Extractiona 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 | Procedure or surgery | Vestibular Root Extraction |
| Atraumatic extractions using periotomes followed by conventional forcepsa 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. | Procedure or surgery | Atraumatic extractions using periotomes followed by conventional forceps |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Root Extraction and Atraumatic extractions using periotomes followed by conventional forceps in people with Tooth Extraction, run by Hams Hamed Abdelrahman at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in post restorative soft tissue height (time frame: at baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.