Dental ImplantsNCT05112796
Vestibular Socket Therapy (VST) Versus Partial Extraction Therapy
A study testing Class I extractions sites received immediate implants using the Vestibular Socket Therapy and class I extractions sites received immediate implants using the Partial Extraction Therapy in people with Dental Implants, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
The current randomized clinical trial aimed to compare the VST versus Partial Extraction Therapy (PET) for immediate implant placement in the esthetic zone in class I fresh extraction sites. The primary outcome was the assessment of vertical dimensional changes in peri-implant soft tissue margin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implants
- What is being tested?
- Class I extractions sites received immediate implants using the Vestibular Socket Therapy and class I extractions sites received immediate implants using the Partial Extraction Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 24 Mar 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 hopeless maxillary tooth in the esthetic zone
- non-smokers
- systemically healthy
- Class I extraction sites
Who cannot join
- smoking
- Class II and III extraction sites
- hopeless teeth with acute infection or vertical/horizontal root fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vestibular Socket Therapy (VST) Versus Partial Extraction Therapy (PET) for Treating Fresh Extraction Sites With Thin Labial Plate of Bone With Immediate Implant Placement in the Esthetic Zone: A Randomized Clinical Trial
The current randomized clinical trial aimed to compare the VST versus Partial Extraction Therapy (PET) for immediate implant placement in the esthetic zone in class I fresh extraction sites.
The primary outcome was the assessment of vertical dimensional changes in peri-implant soft tissue margin.
The secondary outcome was the assessment of radiographic changes in the thickness of the facial peri-implant tissues.
- Conditions
- Dental Implants
- Being tested
- Class I extractions sites received immediate implants using the Vestibular Socket Therapy, class I extractions sites received immediate implants using the Partial Extraction Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Class I extractions sites received immediate implants using the Vestibular Socket TherapyProcedure or surgery
A 1-cm-long vestibular access incision was made using a 15c blade 3 to 4 mm apical to the mucogingival junction at the related socket. A subperiosteal tunnel was created connecting the socket orifice and the vestibular access incision
class I extractions sites received immediate implants using the Partial Extraction TherapyProcedure or surgery
the hopeless tooth was decoronated 1 mm coronal to the gingival margin using a diamond bur. Then, the facial root segment was separated from the rest of the root using a Lindemann bur in gentle mesiodistal sweeping strokes from the gingival margin to the apex of the root, aiming to separate the palatal and the labial root segments.
| Study group | Role | What they receive |
|---|---|---|
| VST technique | Experimental | Not described Receives: Procedure: Class I extractions sites received immediate implants using the Vestibular Socket Therapy |
| PET technique | Active comparator | Not described Receives: Procedure: class I extractions sites received immediate implants using the Partial Extraction Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the peri-implant facial tissue thickness
through CBCT images (Carestream 8000D- Carestream Dental) that were taken at baseline and 6 months postoperatively
Measured: at baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start1 Jan 2020
- Primary completion24 Mar 2021
- Study completion24 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 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
- NCT05112796
- Sponsor's protocol ID
- VST_PET_20
- Status last verified
- Oct 2021
- First submitted
- 29 Oct 2021
- Last updated
- 9 Nov 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 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Socket Therapy (VST) Versus Partial Extraction Therapy (PET) for Treating Fresh Extraction Sites With Thin Labial Plate of Bone With Immediate Implant Placement in the Esthetic Zone: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05112796
- Acronym / sponsor ID
- VST_PET_20
- Conditions
- Dental Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 24 Mar 2021 (actual)
- Study completion
- 24 Mar 2021 (actual)
- First posted
- 9 Nov 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.
The current randomized clinical trial aimed to compare the VST versus Partial Extraction Therapy (PET) for immediate implant placement in the esthetic zone in class I fresh extraction sites.
The primary outcome was the assessment of vertical dimensional changes in peri-implant soft tissue margin.
The secondary outcome was the assessment of radiographic changes in the thickness of the facial peri-implant tissues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VST technique | Experimental | Procedure: Class I extractions sites received immediate implants using the Vestibular Socket Therapy |
| PET technique | Active comparator | Procedure: class I extractions sites received immediate implants using the Partial Extraction Therapy |
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 hopeless maxillary tooth in the esthetic zone
- non-smokers
- systemically healthy
- Class I extraction sites
Key exclusion criteria (3 listed)
- smoking
- Class II and III extraction sites
- hopeless teeth with acute infection or vertical/horizontal root fracture
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 |
|---|---|---|
| Class I extractions sites received immediate implants using the Vestibular Socket TherapyA 1-cm-long vestibular access incision was made using a 15c blade 3 to 4 mm apical to the mucogingival junction at the related socket. A subperiosteal tunnel was created connecting the socket orifice and the vestibular access incision | Procedure or surgery | VST technique |
| class I extractions sites received immediate implants using the Partial Extraction Therapythe hopeless tooth was decoronated 1 mm coronal to the gingival margin using a diamond bur. Then, the facial root segment was separated from the rest of the root using a Lindemann bur in gentle mesiodistal sweeping strokes from the gingival margin to the apex of the root, aiming to separate the palatal and the labial root segments. | Procedure or surgery | PET technique |
Primary outcome
Changes in the peri-implant facial tissue thickness
Time frame: at baseline and 6 months
through CBCT images (Carestream 8000D- Carestream Dental) that were taken at baseline and 6 months postoperatively
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 9 Nov 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 Class I extractions sites received immediate implants using the Vestibular Socket Therapy and class I extractions sites received immediate implants using the Partial Extraction Therapy in people with Dental Implants, 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 9 Nov 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 the peri-implant facial tissue thickness (time frame: at baseline and 6 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 9 Nov 2021.