Loss of Teeth Due to ExtractionNCT05005585
Vestibular Socket Therapy With Simultaneous Implant Placement Versus Contour Augmentation With Early Implant Placement
A study testing immediate implant in people with Loss of Teeth Due to Extraction, run by Cairo University at 3 sites in Egypt.
Trial summary
immediate implant placement with VST technique versus early implant placement with contour augmentation in fresh extraction sockets in the esthetic zone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Loss of Teeth Due to Extraction
- What is being tested?
- immediate implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesEgypt
- Study dates
- 1 Dec 2021to 1 Apr 2023
- 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
- Non-restorable maxillary teeth in the esthetic zone
- Intact adjacent teeth
- Adequate palatal and apical bone that allows achieving implant primary stability.
- Compromised sockets type II defect (Nicolas Elian 2007)
- ≥18 years
- Systemically healthy patients
Who cannot join
- Extraction sockets with acute or chronic infection or with adjacent infected teeth
- Heavy Smokers > than 10 cigarettes daily
- Cancer patients undergoing radiotherapy or chemotherapy during or within the last 6 months.
- Unmotivated patients to maintain adequate oral hygiene to follow up.
- Patients with physical disabilities that could affect follow up.
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Faculty of dentistry Cairo university
Cairo, Giza Governorate, 11865
amir alaa elawady, BDS, 00201020205791, amir112093@miuegypt.edu.eg
Mohamed Amr Elkhashab, PHD, 01006611525, mohamed.elkhashab@dentistry.cu.edu.eg
Faculty of dentistry
Cairo, Manial, 12911
Iman AbdelWahab Radi
Cairo, 11518
About this study
Official title: Vestibular Socket Therapy With Simultaneous Implant Placement Versus Contour Augmentation With Early Implant Placement in Fresh Extraction Sockets : A Randomized Clinical Trial
immediate implant placement with VST technique versus early implant placement with contour augmentation in fresh extraction sockets in the esthetic zone.
Read the detailed description
comparing VST technique with immediate implant placement that end up with final crown after 2 months with contour augmentation with early implant placement after 4- 8 weeks of soft tissue healing , then after 3 months final crown delivery both in fresh extraction sockets in the esthetic zone .
- Conditions
- Loss of Teeth Due to Extraction
- Being tested
- immediate implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implantProcedure or surgery
immediate implant placement with VST technique versus early implant placement with contour augmentation technique
| Study group | Role | What they receive |
|---|---|---|
| vestibuler socket therapy | Experimental | immediate implant placement in esthatic zone with final crown placement after 2 months with VST technique Receives: Procedure: immediate implant |
| contour augmentation | Experimental | Early implant placement in esthatic zone with contour augmentation and final crown after 3 months of implant placement Receives: Procedure: immediate implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival
If there is no pain or tenderness on use, no mobility, no history of exudates and radiographic bone loss is less than 2 mm from initial surgery implant the implant is considered successful
Measured: 12 months
Secondary outcomes (2)
Changes in the height and thickness of the labial plate of bone
will be measured by superimposing CBCT images obtained at the baseline (time of tooth extraction) and those after 12 months postimplant placement.
Measured: 12 months
Changes in soft tissue height
were 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 the baseline (of the unrestorable tooth) with those after 12 months of implant insertion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Loss of Teeth Due to ExtractionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- VST with immediate implant placement versus contour augmentation with early implant placement in fresh extraction sockets in esthetic zone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iman Abd-ElWahab Radi, PhD, Cairo University
- Investigators
- Iman Radi, PHD, Study director, Professor of prosthodonticsAbdelSalam ElAsakry, BDS, Study director, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005585
- Sponsor's protocol ID
- vst versus contour aug.
- Status last verified
- Nov 2021
- First submitted
- 6 Aug 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Socket Therapy With Simultaneous Implant Placement Versus Contour Augmentation With Early Implant Placement in Fresh Extraction Sockets : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05005585
- Acronym / sponsor ID
- vst versus contour aug.
- Conditions
- Loss of Teeth Due to Extraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 13 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.
immediate implant placement with VST technique versus early implant placement with contour augmentation in fresh extraction sockets in the esthetic zone.
Detailed description
comparing VST technique with immediate implant placement that end up with final crown after 2 months with contour augmentation with early implant placement after 4- 8 weeks of soft tissue healing , then after 3 months final crown delivery both in fresh extraction sockets in the esthetic zone .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- VST with immediate implant placement versus contour augmentation with early implant placement in fresh extraction sockets in esthetic zone.
| Arm | Type | Receives |
|---|---|---|
| vestibuler socket therapy | Experimental | Procedure: immediate implantimmediate implant placement in esthatic zone with final crown placement after 2 months with VST technique |
| contour augmentation | Experimental | Procedure: immediate implantEarly implant placement in esthatic zone with contour augmentation and final crown after 3 months of implant placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Non-restorable maxillary teeth in the esthetic zone
- Intact adjacent teeth
- Adequate palatal and apical bone that allows achieving implant primary stability.
- Compromised sockets type II defect (Nicolas Elian 2007)
- ≥18 years
Key exclusion criteria (5 listed)
- Extraction sockets with acute or chronic infection or with adjacent infected teeth
- Heavy Smokers > than 10 cigarettes daily
- Cancer patients undergoing radiotherapy or chemotherapy during or within the last 6 months.
- Unmotivated patients to maintain adequate oral hygiene to follow up.
- Patients with physical disabilities that could affect follow up.
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 |
|---|---|---|
| immediate implantimmediate implant placement with VST technique versus early implant placement with contour augmentation technique | Procedure or surgery | contour augmentation, vestibuler socket therapy |
Primary outcome
Implant survival
Time frame: 12 months
If there is no pain or tenderness on use, no mobility, no history of exudates and radiographic bone loss is less than 2 mm from initial surgery implant the implant is considered successful
2 secondary outcomes
Changes in the height and thickness of the labial plate of bone
Time frame: 12 months
Changes in soft tissue height
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
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.
Iman Radi, PHD study director
Professor of prosthodontics
AbdelSalam ElAsakry, BDS study director
Private Practice
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immediate implant in people with Loss of Teeth Due to Extraction, run by Cairo University at 3 sites 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 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 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact amir elawady, BDS (00201020205791, amir112093@miuegypt.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survival (time frame: 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 18 Nov 2021.