Bone LossNCT05261334
Socket Shield Technique Versus Early Implant Placement With Contour Augmentation
A study testing contour augmentation in people with Bone Loss and Bone Resorption, run by Iman Abd-ElWahab Radi, PhD at 1 site in Egypt.
Trial summary
comparing socket shield technique with early implant placement with contour augmentation in preserving the bone contour Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Bone Resorption
- What is being tested?
- contour augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Mar 2022to 1 Sep 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 to 60 years
- All sexes
- Healthy volunteers accepted
- 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.
- Type I socket
- ≥18 years
- ≤ 60 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
1 site in 1 country.
Egypt1 site
Cairo University
Cairo, 11553
iman abdelwahab radi, PHD, 01001539613 ext. 002, iman.abdelwahab@dentistry.cu.edu.eg
Amir alaa Elawady, BDS, 01020205791, Amir112093@miuegypt.edu.eg
About this study
Official title: Socket Shielding in Immediate Versus Early Implant Placement With Contour Augmentation of Fresh Extraction Sockets in the Esthetic Zone. A Randomized Pilot Clinical Study.
comparing socket shield technique with early implant placement with contour augmentation in preserving the bone contour
Read the detailed description
comparing immediate implant placement with socket shield technique and final crown after 3 months with extraction and after 4 to 8 weeks implant placement with contour bone augmentation then after 3 to 4 months final crown delivery
- Conditions
- Bone Loss, Bone Resorption
- Being tested
- contour augmentation
- Medical subject headings
- Bone Diseases, Metabolic, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contour augmentationProcedure or surgery
early implant placement with contour bone augmentation
| Study group | Role | What they receive |
|---|---|---|
| socket shield technique | Active comparator | immediate implant placement with socket shield technique Receives: Procedure: contour augmentation |
| contour augmentation | Active comparator | early implant placement with contour bone augmentation Receives: Procedure: contour augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
facial bone thickness
using superimposed CBCT images
Measured: 12 months
Secondary outcomes (2)
facial bone height changes
using superimposed CBCT images
Measured: 12 months
Soft tissue height changes
using superimposed intraoral scans
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 posted2 Mar 2022
- Study start31 Mar 2022 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies 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
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iman Abd-ElWahab Radi, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Iman Abd-ElWahab Radi, PhD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261334
- Sponsor's protocol ID
- sst versus contour aug
- Status last verified
- Mar 2022
- First submitted
- 28 Jan 2022
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socket Shielding in Immediate Versus Early Implant Placement With Contour Augmentation of Fresh Extraction Sockets in the Esthetic Zone. A Randomized Pilot Clinical Study.
- ClinicalTrials.gov ID
- NCT05261334
- Acronym / sponsor ID
- sst versus contour aug
- Conditions
- Bone Loss, Bone Resorption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Iman Abd-ElWahab Radi, PhDUniversity, hospital or other
- Study start
- 31 Mar 2022 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 2 Mar 2022 (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.
comparing socket shield technique with early implant placement with contour augmentation in preserving the bone contour
Detailed description
comparing immediate implant placement with socket shield technique and final crown after 3 months with extraction and after 4 to 8 weeks implant placement with contour bone augmentation then after 3 to 4 months final crown delivery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| socket shield technique | Active comparator | Procedure: contour augmentationimmediate implant placement with socket shield technique |
| contour augmentation | Active comparator | Procedure: contour augmentationearly implant placement with contour bone augmentation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Non-restorable maxillary teeth in the esthetic zone
- Intact adjacent teeth
- Adequate palatal and apical bone that allows achieving implant primary stability.
- Type I socket
- ≥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 |
|---|---|---|
| contour augmentationearly implant placement with contour bone augmentation | Procedure or surgery | contour augmentation, socket shield technique |
Primary outcome
facial bone thickness
Time frame: 12 months
using superimposed CBCT images
2 secondary outcomes
facial bone height changes
Time frame: 12 months
Soft tissue height changes
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 25 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing contour augmentation in people with Bone Loss and Bone Resorption, run by Iman Abd-ElWahab Radi, PhD 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 7 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 25 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
facial bone thickness (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 25 Mar 2022.