Immediate Implant PlacementNCT05880771
Immediate Implant Placement: a Clinical and Radiographic Study on Hard and Soft Tissues Retraction at One Year.
A study testing Immediate Implant Placement in people with Immediate Implant Placement and Guided Surgery, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
This project consists of placing dental implants at extraction sites. Bone drilling and implant placement are performed using the flapless method with the use of a surgical guide allowing guided surgery. Read more about this study
- Who is it for?
- Ages 35 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Implant Placement, Guided Surgery, Immediate Tamporization
- What is being tested?
- Immediate Implant Placement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jan 2021to 30 Nov 2024
- 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 35 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Absence of systemic or osseous disease that may impair peri-implant healing
- Age ≥ 21 years
- Acceptable oral hygiene
- Presence of both adjacent teeth
- Absence of acute infection in the treated area
- Absence of periodontal pockets > 3mm at the concerned site
Show all 9Show fewer
- Absence of pre-operative defect at the buccal bone wall (dehiscence or fenestration)
- Per-operative integrity of the osseous and gingival structures (during tooth extraction)
- Light or non-smoker (<10 cigarettes per day)
Who cannot join
- Myocardial infarction within the past 6 months.
- Poorly controlled diabetes (HBA1c > 7.5%).
- Coagulation disorders.
- Radiotherapy to the head/neck area within the past two years.
- Present or past treatment with intravenous bisphosphonates.
- Immunocompromised patients.
Show all 10Show fewer
- Psychological or psychiatric problems.
- Alcohol or drug abuse.
- Poor oral hygiene and motivation (full mouth plaque score > 30% and/or full mouth bleeding score > 20%).
- Uncontrolled periodontal disease.
Trial locations and contacts
1 site in 1 country.
About this study
This project consists of placing dental implants at extraction sites. Bone drilling and implant placement are performed using the flapless method with the use of a surgical guide allowing guided surgery. After implant placement, temporary teeth are immediately made and placed on the implants to guide the gingival contour.
Bone and soft tissue retraction at the implanted sites are measured radiographically and digitally using surface scan superimposition over a 12-month period.
- Being tested
- Immediate Implant Placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Implant PlacementOther
Tooth extraction followed by immediate implant placement. One group will have Allograft graft in the buccal gap, the other will have Xenograft graft.
| Study group | Role | What they receive |
|---|---|---|
| Immediate implant placement with buccal gap grafted with Allograft | Experimental | Following tooth extraction immediate implant will be placed in the palatal bone and the buccal gap between the implant and the buccal bone will be grafted with Allograft Receives: Other: Immediate Implant Placement |
| Immediate implant placement with buccal gap grafted with Xenograft | Experimental | Following tooth extraction immediate implant will be placed in the palatal bone and the buccal gap between the implant and the buccal bone will be grafted with Xenograft Receives: Other: Immediate Implant Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hard tissue change by superimposing CBCT scans between 0 and 12 months using 3d slicer software
Buccal bone profil retraction after immediate implant placement using 2 different bone substitutes by comparing CBCT Dicom files at 0 and 12 months using 3d slicer software
Measured: 12 months
Soft tissue change by superimposing surface intraoral scans between 0 and 12 months using 3d slicer software
Soft Tissue profil retraction after immediate implant placement using 2 different bone substitutes by superimposing STL files between 0 and 12 monts using 3d slicer software
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 posted30 May 2023
- Study start1 Jan 2021
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Makary, Saint-Joseph University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880771
- Sponsor's protocol ID
- XFMD203
- Status last verified
- Jul 2023
- First submitted
- 14 May 2023
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Implant Placement: a Clinical and Radiographic Study on Hard and Soft Tissues Retraction at One Year.
- ClinicalTrials.gov ID
- NCT05880771
- Acronym / sponsor ID
- XFMD203
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 30 May 2023 (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.
This project consists of placing dental implants at extraction sites. Bone drilling and implant placement are performed using the flapless method with the use of a surgical guide allowing guided surgery. After implant placement, temporary teeth are immediately made and placed on the implants to guide the gingival contour.
Bone and soft tissue retraction at the implanted sites are measured radiographically and digitally using surface scan superimposition over a 12-month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate implant placement with buccal gap grafted with Allograft | Experimental | Other: Immediate Implant PlacementFollowing tooth extraction immediate implant will be placed in the palatal bone and the buccal gap between the implant and the buccal bone will be grafted with Allograft |
| Immediate implant placement with buccal gap grafted with Xenograft | Experimental | Other: Immediate Implant PlacementFollowing tooth extraction immediate implant will be placed in the palatal bone and the buccal gap between the implant and the buccal bone will be grafted with Xenograft |
Who may qualify
- Ages
- 35 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Absence of systemic or osseous disease that may impair peri-implant healing
- Age ≥ 21 years
- Acceptable oral hygiene
- Presence of both adjacent teeth
- Absence of acute infection in the treated area
Key exclusion criteria (10 listed)
- Myocardial infarction within the past 6 months.
- Poorly controlled diabetes (HBA1c > 7.5%).
- Coagulation disorders.
- Radiotherapy to the head/neck area within the past two years.
- Present or past treatment with intravenous bisphosphonates.
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 Implant PlacementTooth extraction followed by immediate implant placement. One group will have Allograft graft in the buccal gap, the other will have Xenograft graft. | Other | Immediate implant placement with buccal gap grafted with Allograft, Immediate implant placement with buccal gap grafted with Xenograft |
Primary outcome
Hard tissue change by superimposing CBCT scans between 0 and 12 months using 3d slicer software
Time frame: 12 months
Buccal bone profil retraction after immediate implant placement using 2 different bone substitutes by comparing CBCT Dicom files at 0 and 12 months using 3d slicer software
Soft tissue change by superimposing surface intraoral scans between 0 and 12 months using 3d slicer software
Time frame: 12 months
Soft Tissue profil retraction after immediate implant placement using 2 different bone substitutes by superimposing STL files between 0 and 12 monts using 3d slicer software
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 16 May 2025.
- 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.
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 Immediate Implant Placement in people with Immediate Implant Placement and Guided Surgery, run by Saint-Joseph University at 1 site in Lebanon.
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 9 inclusion and 10 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 16 May 2025. 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 Lebanon. 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?
Hard tissue change by superimposing CBCT scans between 0 and 12 months using 3d slicer software (time frame: 12 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 16 May 2025.