Tooth ExtractionNCT04930497
Vestibular Socket Therapy With and Without Bone Grafting
A study testing vestibular socket technique with bone grafting and vestibular socket technique without bone grafting in people with Tooth Extraction, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Management of the jumping gap in the Vestibular Socket Therapy. And to study what is the best technique to manage this gap for optimal esthetic result. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Tooth Extraction
- What is being tested?
- vestibular socket technique with bone grafting and vestibular socket technique without bone grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2019to 30 Jan 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- presence of a hopeless tooth or teeth in the esthetic zone (maxillary anterior area)
- No active infection
- Adequate bone palatally and apically
- Presence of contralateral tooth for the tooth being replaced
Who cannot join
- Hopeless tooth with acute infection
- heavy smokers (more than 10 cigarettes per day)
- pregnant and patients received recent chemotherapy/radiotherapy (during the previous year)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Implant Placement Using Vestibular Socket Therapy With and Without Bone Grafting (Randomized Controlled Clinical Trial)
Management of the jumping gap in the Vestibular Socket Therapy. And to study what is the best technique to manage this gap for optimal esthetic result.
Read the detailed description
22 patients were randomly assigned to Group 1: Had received implants with the vestibular socket technique accompanied with bone grafting the jumping gap between the implant and the labial membrane.
Group 2: Had received implants with the vestibular socket technique, but without bone grafting the jumping gap.
Facial bone thickness and height were evaluated using CBCT scans at baseline before tooth extraction and after 6 and 13 months
- Conditions
- Tooth Extraction
- Being tested
- vestibular socket technique with bone grafting, vestibular socket technique without bone grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vestibular socket technique with bone graftingProcedure or surgery
a vestibular horizontal incision was made then a subperiosteal tunnel was created and a facial bone membrane was placed. The facial gap was filled with a mixture of autogenous bone and deproteinized bovine bone mineral
vestibular socket technique without bone graftingProcedure or surgery
the vestibular incision was done horizontally about 3 to 4 mm apical to the mucogingival junction and extending 5 to 10 mm horizontally. A submucoperiosteal tunnel was created labially from the socket orifice till the vestibular access incision
| Study group | Role | What they receive |
|---|---|---|
| vestibular socket technique with bone grafting | Experimental | Not described Receives: Procedure: vestibular socket technique with bone grafting |
| vestibular socket technique without bone grafting | Active comparator | Not described Receives: Procedure: vestibular socket technique without bone grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Facial bone thickness
using CBCT scans (Carestream 8000D, Carestream Dental)
Measured: baseline, 6 months and 13 months
Change in Facial bone height
using CBCT scans (Carestream 8000D, Carestream Dental)
Measured: baseline, 6 months and 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start20 Nov 2019
- Primary completion30 Jan 2021
- Study completion30 Jan 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
- 22 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
- NCT04930497
- Sponsor's protocol ID
- VST_bone grafting
- Status last verified
- Jul 2021
- First submitted
- 11 Jun 2021
- Last updated
- 23 Jul 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 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Implant Placement Using Vestibular Socket Therapy With and Without Bone Grafting (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT04930497
- Acronym / sponsor ID
- VST_bone grafting
- Conditions
- Tooth Extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 18 Jun 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.
Management of the jumping gap in the Vestibular Socket Therapy. And to study what is the best technique to manage this gap for optimal esthetic result.
Detailed description
22 patients were randomly assigned to Group 1: Had received implants with the vestibular socket technique accompanied with bone grafting the jumping gap between the implant and the labial membrane.
Group 2: Had received implants with the vestibular socket technique, but without bone grafting the jumping gap.
Facial bone thickness and height were evaluated using CBCT scans at baseline before tooth extraction and after 6 and 13 months
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vestibular socket technique with bone grafting | Experimental | Procedure: vestibular socket technique with bone grafting |
| vestibular socket technique without bone grafting | Active comparator | Procedure: vestibular socket technique without bone grafting |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- presence of a hopeless tooth or teeth in the esthetic zone (maxillary anterior area)
- No active infection
- Adequate bone palatally and apically
- Presence of contralateral tooth for the tooth being replaced
Key exclusion criteria (3 listed)
- Hopeless tooth with acute infection
- heavy smokers (more than 10 cigarettes per day)
- pregnant and patients received recent chemotherapy/radiotherapy (during the previous year)
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 socket technique with bone graftinga vestibular horizontal incision was made then a subperiosteal tunnel was created and a facial bone membrane was placed. The facial gap was filled with a mixture of autogenous bone and deproteinized bovine bone mineral | Procedure or surgery | vestibular socket technique with bone grafting |
| vestibular socket technique without bone graftingthe vestibular incision was done horizontally about 3 to 4 mm apical to the mucogingival junction and extending 5 to 10 mm horizontally. A submucoperiosteal tunnel was created labially from the socket orifice till the vestibular access incision | Procedure or surgery | vestibular socket technique without bone grafting |
Primary outcome
Change in Facial bone thickness
Time frame: baseline, 6 months and 13 months
using CBCT scans (Carestream 8000D, Carestream Dental)
Change in Facial bone height
Time frame: baseline, 6 months and 13 months
using CBCT scans (Carestream 8000D, Carestream Dental)
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 23 Jul 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 socket technique with bone grafting and vestibular socket technique without bone grafting 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 23 Jul 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?
Change in Facial bone thickness (time frame: baseline, 6 months and 13 months). The study lists 2 primary outcomes in all. 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 23 Jul 2021.