Immediate Implant PlacementNCT06648135
Labial Bone Thickness Around Immediate Implants in the Esthetic Zone Following a Novel Socket Evaluation System
An observational study of Immediate Implant Placement, run by Misr International University at 1 site in Egypt.
Trial summary
The anterior maxilla is a particularly challenging area for immediate implant placement due to its thin buccal bone walls. These walls are more susceptible to resorption after tooth extraction, which can lead to significant bone loss and inadequate support for an implant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immediate Implant Placement
- What is being tested?
- Immediate implants with bone grafts and Immediate implant placed without bone grafts or any grafting substitutes in the labial gap
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 1 Jul 2026
- How long will I take part?
- 5 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Primary care clinic
Who may be able to join
- Immedaite implants in anterior maxilla
- thick gingival phenotype
- intact but thin labial plate of bone (≤1mm)
- sufficient apical bone to attain implant primary stability (a minimum of 35 Ncm insertion torque)
Who cannot join
- smokers
- pregnant women
- patients with systemic disease
- patients with parafunctional habits such as bruxism or clenching,
- infected socket
- periapical pathosis
- history of radiotherapy or chemotherapy within the past 2 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
International Dental Clinic Educational centre
Cairo
Ahmed aboul fettouh, PhD, +201019999983, ahmedkey7@hotmail.com
Mariam Hanna, Mds, +201226536514, mariamsamy47@gmail.com
About this study
Official title: a Novel Socket Evaluation System and Its Impact on Bone Formed Labial to Bone Immediate Anterior Implants. A 1-year Clinical Trial.
The anterior maxilla is a particularly challenging area for immediate implant placement due to its thin buccal bone walls. These walls are more susceptible to resorption after tooth extraction, which can lead to significant bone loss and inadequate support for an implant. However, Different socket dimension may affect the amount of bone formed labial to the implant, regardless of the garfting procedure.
Read the detailed description
Bone formation labial to the immediate implant is not related to the initial thick- ness of the labial plate of bone, rather than the initial labio-palatal socket dimension. this study aims to evaluate the bone formed labial to the implant following a Novel Socket Evaluation System.
- Conditions
- Immediate Implant Placement
- Being tested
- Immediate implants with bone grafts, Immediate implant placed without bone grafts or any grafting substitutes in the labial gap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implants with bone graftsProcedure or surgery
Immediate implants with bone grafts
Immediate implant placed without bone grafts or any grafting substitutes in the labial gapProcedure or surgery
Immediate implant placed without bone grafts or any grafting substitutes in the labial gap
| Study group | Role | What they receive |
|---|---|---|
| Bone grafts | Immediate implant placed with bone grafts in the labial gap Receives: Procedure: Immediate implants with bone grafts | |
| No bone grafts | Immediate implant placed without bone grafts or any grafting substitutes in the labial gap Receives: Procedure: Immediate implant placed without bone grafts or any grafting substitutes in the labial gap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone labial to the implant
measured at three levels 0, 2, and 5 mm below the labial bone crest after one year. Using fusion software.
Measured: one year
Secondary outcomes (1)
Bone area at the Interproximal component
Bone area at the mesial and distal Interproximal component in mm2
Measured: preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start1 Mar 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Implant PlacementStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
- Target duration
- 5 Months
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abo El Futtouh, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648135
- Sponsor's protocol ID
- IDCE 14
- Status last verified
- Jan 2026
- First submitted
- 16 Oct 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Novel Socket Evaluation System and Its Impact on Bone Formed Labial to Bone Immediate Anterior Implants. A 1-year Clinical Trial.
- ClinicalTrials.gov ID
- NCT06648135
- Acronym / sponsor ID
- IDCE 14
- Conditions
- Immediate Implant Placement
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 18 Oct 2024 (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 anterior maxilla is a particularly challenging area for immediate implant placement due to its thin buccal bone walls. These walls are more susceptible to resorption after tooth extraction, which can lead to significant bone loss and inadequate support for an implant. However, Different socket dimension may affect the amount of bone formed labial to the implant, regardless of the garfting procedure.
Detailed description
Bone formation labial to the immediate implant is not related to the initial thick- ness of the labial plate of bone, rather than the initial labio-palatal socket dimension. this study aims to evaluate the bone formed labial to the implant following a Novel Socket Evaluation System.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone grafts | – | Procedure: Immediate implants with bone graftsImmediate implant placed with bone grafts in the labial gap |
| No bone grafts | – | Procedure: Immediate implant placed without bone grafts or any grafting substitutes in the labial gapImmediate implant placed without bone grafts or any grafting substitutes in the labial gap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (4 listed)
- Immedaite implants in anterior maxilla
- thick gingival phenotype
- intact but thin labial plate of bone (≤1mm)
- sufficient apical bone to attain implant primary stability (a minimum of 35 Ncm insertion torque)
Key exclusion criteria (7 listed)
- smokers
- pregnant women
- patients with systemic disease
- patients with parafunctional habits such as bruxism or clenching,
- infected socket
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 implants with bone graftsImmediate implants with bone grafts | Procedure or surgery | Bone grafts |
| Immediate implant placed without bone grafts or any grafting substitutes in the labial gapImmediate implant placed without bone grafts or any grafting substitutes in the labial gap | Procedure or surgery | No bone grafts |
Primary outcome
Bone labial to the implant
Time frame: one year
measured at three levels 0, 2, and 5 mm below the labial bone crest after one year. Using fusion software.
1 secondary outcome
Bone area at the Interproximal component
Time frame: preoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immediate Implant Placement, run by Misr International University 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 7 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: opening soon, as of the sponsor's last update on 28 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed I Aboul Fettouh, PhD (+201019999983, ahmed.abouelfotouh@miuegypt.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone labial to the implant (time frame: one year). 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 28 Jan 2026.