Bone ResorptionNCT07080710
State of the Art Immediate Implant Placement in the Premaxilla
A study testing Immediate implant placement in people with Bone Resorption, run by University Ghent at 2 sites in Belgium.
Trial summary
The goal of this clinical study is to learn how well immediate implant placement works in the front upper jaw (premaxilla) when using flapless guided surgery, hard and soft tissue augmentation, and immediate provisional crowns. It will also learn about the safety and esthetic results of this treatment approach. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption
- What is being tested?
- Immediate implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Jul 2025to 1 Feb 2032
- Phase
- Interventional
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 20 years old
- Good oral hygiene defined as full-mouth plaque score ≤ 25%
- Presence of one or more incisors, cuspids or premolars in the maxilla that need to be extracted for any reason with at least one neighboring tooth present
- At least 3 mm bone available at the apical or palatal aspect of the alveoli as assessed on a three-dimensional radiograph to ensure primary implant stability
- Written informed consent.
Who cannot join
- Pregnancy (will be explicitly asked)
- Systemic diseases
- Smoking; suppuration
- > 1 mm gingival asymmetry between the failing teeth and contralateral teeth
- Failing teeth outside the bone envelop as assessed on a three-dimensional radiograph
- Untreated periodontal disease; untreated caries lesions.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
Ghent University
Ghent, East Flanders, 9000
Véronique Christiaens, PhD, 09/332 40 17, vchristi.christiaens@UGent.be
- Recruiting
Bv Dr. Cosyn
Zottegem, East Flanders, 9620
Jan Cosyn, Prof. Dr., 0496 10 01 21, jan.cosyn@ugent.be
About this study
Official title: A Clinical Study on Immediate Implant Placement in the Premaxilla With Flapless Guided Surgery, Hard and Soft Tissue Augmentation and Immediate Provisionalization
The goal of this clinical study is to learn how well immediate implant placement works in the front upper jaw (premaxilla) when using flapless guided surgery, hard and soft tissue augmentation, and immediate provisional crowns. It will also learn about the safety and esthetic results of this treatment approach.
The main questions it aims to answer are:
Read more
Primary:
How much buccal bone thickness remains one year after implant placement 1mm below the implant shoulder?
Secondary:
- How do patients rate pain, healing, and esthetics after treatment?
- Are there any complications over the course of five years?
- How much buccal bone thickness remains one year after implant placement 3mm and 5mm below the implant shoulder?
- Marginal bone loss at one-year and five-year follow-up?
- Peri-implant health at one-year and five-year follow-up?
- Soft tissue changes at one-year and five-year follow-up?
Researchers will compare treatment results in patients with intact bone sockets to those with damaged (non-intact) sockets.
Participants will:
- Receive a dental implant and temporary crown on the same day as the tooth extraction
- Undergo guided, flapless surgery with bone and soft tissue grafting
- Take antibiotics and anti-inflammatories for 4 days after surgery
- Visit the clinic at 1 week, 3 months, 1 year, and 5 years for follow-up exams
- Have X-rays, digital scans, and photos taken to measure bone and soft tissue changes
- Answer questions about pain and esthetic satisfaction
Read the detailed description
Preoperative three-dimensional radiograph and intra-oral digital impression:
Required to select eligible patients. All three-dimensional radiographs will be taken with lip retractors.
An intra-oral digital impression of the maxilla will also be taken. Designated software will be used to merge dicoms files (three-dimensional radiograph) and the STL file (intra-oral digital impression) to fabricate a surgical guide.
Surgery:
All surgeries will be performed by two implant surgeons . Patients start to take systemic antibiotics (Amoxicilline 1g) and anti-inflammatory medication (Ibuprofen 600 mg) 1h pre-operatively. Following local anesthesia and oral disinfection the failing tooth is extracted as atraumatically as possible and without raising a flap. Following wound debridement, a cutting implant is installed in an optimal 3D position using a surgical guide. Socket grafting is performed with collagen-enriched deproteinized bovine bone mineral to limit buccal bone resorption and to optimize soft tissue stability. Thereupon, a free gingival graft is harvested from the palatal mucosa in the premolar area and de-epithelialized to arrive at a connective tissue graft (CTG) between 1 mm and 2 mm thickness. Height and length are tailored to the dimensions of the site. Then, the CTG is sutured with two or three single sutures onto the buccal mucosa. Finally, a healing abutment is installed, which is replaced by a provisional implant crown 2 days later. Following provisional crown installation, an intra-oral radiograph is taken. This postoperative intra-oral radiograph is standard in clinical practice, also for patients who are not participating in the study.
When dealing with a shallow non-intact socket (buccal dehiscence < 3 mm = type IIa), the same technique is applied. When dealing with a dehiscence between 4 mm and 6 mm (type IIb), a collagen membrane is applied prior to socket grafting to separate the grafting material from the buccal mucosa. When dealing with a very deep dehiscence (> 6 mm = type IIc), a collagen membrane is also applied and a mixture of C-DBBM and autogenous bone chips (1:1 ratio) is used as grafting material.
Postoperative care:
Patients continue the intake of antibiotics (2 times per day) and anti-inflammatory medication (2 times per day) for 4 days and use a chlorhexidine mouth rinse during 1 week. Sutures are removed 1 week after surgery. At that time point the patient will be asked how many analgesics had been taken, and also the pain intensity will be rated on a numeric rating scale.
These are study-specific evaluations.
Three months after implant installation an intra-oral radiograph is taken to assess osseointegration. This intra-oral radiograph is standard in clinical practice, also for patients who are not participating in the study.
When the implant is successfully integrated, the patient is sent to the general dentist for fabrication of the permanent crown.
1-year registrations:
- Patients' esthetic satisfaction will be assessed on the basis of a numeric rating scale.
- A CBCT will be taken to assess buccal bone thickness at 1 mm, 3 mm and 5 mm below the implant shoulder.
- An intra-oral radiograph is taken to assess marginal bone loss.
- Peri-implant health as clinically assessed on the basis of probing depth, bleeding on probing and plaque.
- Clinical pictures to assess the esthetic outcome of the soft tissues surrounding the crown.
- An intra-oral digital impression will be taken of the upper jaw. The pre-op impression and the one-year impression will be superimposed in designated software to calculate soft tissue changes. 5-year registrations:
- Patients' esthetic satisfaction will be assessed on the basis of a numeric rating scale.
- An intra-oral radiograph is taken to assess marginal bone loss.
- Peri-implant health as clinically assessed on the basis of probing depth, bleeding on probing and plaque.
- Clinical pictures are taken to assess the esthetic outcome of the soft tissues surrounding the crown.
- An intra-oral digital impression will be taken of the upper jaw. The pre-op impression and the five-year impression will be superimposed in designated software to calculate soft tissue changes.
- Conditions
- Bone Resorption
- Being tested
- Immediate implant placement
- Keywords
- dental implant, single-tooth, Immediate, connective tissue graft, socket grafting, intact alveolus, non-intact alveolus
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant placementProcedure or surgery
Immediate implant placement with socket grafting and soft tissue augmentation. In cases with a buccal dehiscence >3mm only this technique is applied. In cases with a buccal dehiscence between 4-6mm a collagen membrane is applied prior to socket grafting. In cases with a buccal dehiscence > 6 mm, a collagen membrane is also applied and a mixture of C-DBBM and autogenous bone chips (1:1 ratio) is used as grafting material.
| Study group | Role | What they receive |
|---|---|---|
| Immediate implant placement | Experimental | State of the art immediate implant placement with socket grafting and soft tissue augmentation. Receives: Procedure: Immediate implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buccal bone thickness -1 (mm)
Buccal bone thickness at 1 mm below the implant shoulder at one-year follow-up as assessed on a three-dimensional radiograph.
Measured: moment of enrollment and 1-year
Secondary outcomes (6)
Patient reported outcomes
One week after surgery, patients will be asked how many analgesics have been taken. In addition, they will be asked to rate postoperative pain on a numeric rating scale (0-10).
Measured: one week after surgery
Pink Esthetic Score
Pink Esthetic Score (PES) is registered by a trained and blinded examiner using frontal and occlusal clinical pictures taken at 1 year and 5-year follow-up. The PES results in a score from 0 (worst esthetic outcome) to 14 (perfect esthetic outcome).
Measured: enrollment, 1-year, 5-year
Buccal bone thickness -3 and -5 (mm)
Buccal bone thickness at 3mm and 5mm below the implant shoulder at one-year follow-up as assessed on a three-dimensional radiograph.
Measured: enrollment and 1-year
Marginal bone loss
Changes in the distance from the implant-abutment interface to the first bone-to-implant contact (so-called marginal bone level) at the mesial and distal aspect of each implant as measured on 2D intra-oral radiographs.
Measured: 1-, 5-year
Peri-implant health
Peri-implant health is clinically assessed on the basis of probing depth, bleeding on probing and plaque.
Measured: 1-, 5-year
Soft tissue changes
An intra-oral digital impression will be taken of the upper jaw. The pre-op impression and the one-year impression will be superimposed in designated software to calculate soft tissue changes.
Measured: enrollment, 1-year , 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Jul 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bone ResorptionStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080710
- Sponsor's protocol ID
- ONZ-2025-0174
- Status last verified
- Nov 2025
- First submitted
- 23 Jun 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If the data can be included in a meta-analysis upon request by the authors, they can be transferred
Publications
Pitman J, Christiaens V, Callens J, Glibert M, Seyssens L, Blanco J, Cosyn J. Immediate implant placement with flap or flapless surgery: A systematic review and meta-analysis. J Clin Periodontol. 2023 Jun;50(6):755-764. doi: 10.1111/jcpe.13795. Epub 2023 Mar 5.
PubMed 36843361Ickroth A, Christiaens V, Pitman J, Cosyn J. A Systematic Review on Immediate Implant Placement in Intact Versus Non-Intact Alveolar Sockets. J Clin Med. 2025 Apr 3;14(7):2462. doi: 10.3390/jcm14072462.
PubMed 40217911Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
PubMed 16307569Botticelli D, Berglundh T, Lindhe J. Hard-tissue alterations following immediate implant placement in extraction sites. J Clin Periodontol. 2004 Oct;31(10):820-8. doi: 10.1111/j.1600-051X.2004.00565.x.
PubMed 15367183Assaf JH, Assaf DD, Antoniazzi RP, Osorio LB, Franca FM. Correction of Buccal Dehiscence During Immediate Implant Placement Using the Flapless Technique: A Tomographic Evaluation. J Periodontol. 2017 Feb;88(2):173-180. doi: 10.1902/jop.2016.160276. Epub 2016 Sep 13.
PubMed 27620655Barone A, Toti P, Marconcini S, Derchi G, Saverio M, Covani U. Esthetic Outcome of Implants Placed in Fresh Extraction Sockets by Clinicians with or without Experience: A Medium-Term Retrospective Evaluation. Int J Oral Maxillofac Implants. 2016 Nov/Dec;31(6):1397-1406. doi: 10.11607/jomi.4646.
PubMed 27861667
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on Immediate Implant Placement in the Premaxilla With Flapless Guided Surgery, Hard and Soft Tissue Augmentation and Immediate Provisionalization
- ClinicalTrials.gov ID
- NCT07080710
- Acronym / sponsor ID
- ONZ-2025-0174
- Conditions
- Bone Resorption
- Keywords
- dental implant, single-tooth, Immediate, connective tissue graft, socket grafting, intact alveolus, non-intact alveolus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2032 (estimated)
- First posted
- 23 Jul 2025 (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 goal of this clinical study is to learn how well immediate implant placement works in the front upper jaw (premaxilla) when using flapless guided surgery, hard and soft tissue augmentation, and immediate provisional crowns. It will also learn about the safety and esthetic results of this treatment approach.
The main questions it aims to answer are:
Primary:
How much buccal bone thickness remains one year after implant placement 1mm below the implant shoulder?
Secondary:
- How do patients rate pain, healing, and esthetics after treatment?
- Are there any complications over the course of five years?
- How much buccal bone thickness remains one year after implant placement 3mm and 5mm below the implant shoulder?
- Marginal bone loss at one-year and five-year follow-up?
- Peri-implant health at one-year and five-year follow-up?
- Soft tissue changes at one-year and five-year follow-up?
Researchers will compare treatment results in patients with intact bone sockets to those with damaged (non-intact) sockets.
Participants will:
- Receive a dental implant and temporary crown on the same day as the tooth extraction
- Undergo guided, flapless surgery with bone and soft tissue grafting
- Take antibiotics and anti-inflammatories for 4 days after surgery
- Visit the clinic at 1 week, 3 months, 1 year, and 5 years for follow-up exams
- Have X-rays, digital scans, and photos taken to measure bone and soft tissue changes
- Answer questions about pain and esthetic satisfaction
Detailed description
Preoperative three-dimensional radiograph and intra-oral digital impression:
Required to select eligible patients. All three-dimensional radiographs will be taken with lip retractors.
An intra-oral digital impression of the maxilla will also be taken. Designated software will be used to merge dicoms files (three-dimensional radiograph) and the STL file (intra-oral digital impression) to fabricate a surgical guide.
Surgery:
All surgeries will be performed by two implant surgeons . Patients start to take systemic antibiotics (Amoxicilline 1g) and anti-inflammatory medication (Ibuprofen 600 mg) 1h pre-operatively. Following local anesthesia and oral disinfection the failing tooth is extracted as atraumatically as possible and without raising a flap. Following wound debridement, a cutting implant is installed in an optimal 3D position using a surgical guide. Socket grafting is performed with collagen-enriched deproteinized bovine bone mineral to limit buccal bone resorption and to optimize soft tissue stability. Thereupon, a free gingival graft is harvested from the palatal mucosa in the premolar area and de-epithelialized to arrive at a connective tissue graft (CTG) between 1 mm and 2 mm thickness. Height and length are tailored to the dimensions of the site. Then, the CTG is sutured with two or three single sutures onto the buccal mucosa. Finally, a healing abutment is installed, which is replaced by a provisional implant crown 2 days later. Following provisional crown installation, an intra-oral radiograph is taken. This postoperative intra-oral radiograph is standard in clinical practice, also for patients who are not participating in the study.
When dealing with a shallow non-intact socket (buccal dehiscence < 3 mm = type IIa), the same technique is applied. When dealing with a dehiscence between 4 mm and 6 mm (type IIb), a collagen membrane is applied prior to socket grafting to separate the grafting material from the buccal mucosa. When dealing with a very deep dehiscence (> 6 mm = type IIc), a collagen membrane is also applied and a mixture of C-DBBM and autogenous bone chips (1:1 ratio) is used as grafting material.
Postoperative care:
Patients continue the intake of antibiotics (2 times per day) and anti-inflammatory medication (2 times per day) for 4 days and use a chlorhexidine mouth rinse during 1 week. Sutures are removed 1 week after surgery. At that time point the patient will be asked how many analgesics had been taken, and also the pain intensity will be rated on a numeric rating scale.
These are study-specific evaluations.
Three months after implant installation an intra-oral radiograph is taken to assess osseointegration. This intra-oral radiograph is standard in clinical practice, also for patients who are not participating in the study.
When the implant is successfully integrated, the patient is sent to the general dentist for fabrication of the permanent crown.
1-year registrations:
- Patients' esthetic satisfaction will be assessed on the basis of a numeric rating scale.
- A CBCT will be taken to assess buccal bone thickness at 1 mm, 3 mm and 5 mm below the implant shoulder.
- An intra-oral radiograph is taken to assess marginal bone loss.
- Peri-implant health as clinically assessed on the basis of probing depth, bleeding on probing and plaque.
- Clinical pictures to assess the esthetic outcome of the soft tissues surrounding the crown.
- An intra-oral digital impression will be taken of the upper jaw. The pre-op impression and the one-year impression will be superimposed in designated software to calculate soft tissue changes. 5-year registrations:
- Patients' esthetic satisfaction will be assessed on the basis of a numeric rating scale.
- An intra-oral radiograph is taken to assess marginal bone loss.
- Peri-implant health as clinically assessed on the basis of probing depth, bleeding on probing and plaque.
- Clinical pictures are taken to assess the esthetic outcome of the soft tissues surrounding the crown.
- An intra-oral digital impression will be taken of the upper jaw. The pre-op impression and the five-year impression will be superimposed in designated software to calculate soft tissue changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Immediate implant placement | Experimental | Procedure: Immediate implant placementState of the art immediate implant placement with socket grafting and soft tissue augmentation. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 20 years old
- Good oral hygiene defined as full-mouth plaque score ≤ 25%
- Presence of one or more incisors, cuspids or premolars in the maxilla that need to be extracted for any reason with at least one neighboring tooth present
- At least 3 mm bone available at the apical or palatal aspect of the alveoli as assessed on a three-dimensional radiograph to ensure primary implant stability
- Written informed consent.
Key exclusion criteria (6 listed)
- Pregnancy (will be explicitly asked)
- Systemic diseases
- Smoking; suppuration
- > 1 mm gingival asymmetry between the failing teeth and contralateral teeth
- Failing teeth outside the bone envelop as assessed on a three-dimensional radiograph
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 placementImmediate implant placement with socket grafting and soft tissue augmentation. In cases with a buccal dehiscence >3mm only this technique is applied. In cases with a buccal dehiscence between 4-6mm a collagen membrane is applied prior to socket grafting. In cases with a buccal dehiscence > 6 mm, a collagen membrane is also applied and a mixture of C-DBBM and autogenous bone chips (1:1 ratio) is used as grafting material. | Procedure or surgery | Immediate implant placement |
Primary outcome
Buccal bone thickness -1 (mm)
Time frame: moment of enrollment and 1-year
Buccal bone thickness at 1 mm below the implant shoulder at one-year follow-up as assessed on a three-dimensional radiograph.
6 secondary outcomes
Patient reported outcomes
Time frame: one week after surgery
Pink Esthetic Score
Time frame: enrollment, 1-year, 5-year
Buccal bone thickness -3 and -5 (mm)
Time frame: enrollment and 1-year
Marginal bone loss
Time frame: 1-, 5-year
Peri-implant health
Time frame: 1-, 5-year
Soft tissue changes
Time frame: enrollment, 1-year , 5-year
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 18 Nov 2025.
- Background: PubMed 36843361Pitman J, Christiaens V, Callens J, Glibert M, Seyssens L, Blanco J, Cosyn J. Immediate implant placement with flap or flapless surgery: A systematic review and meta-analysis. J Clin Periodontol. 2023 Jun;50(6):755-764. doi: 10.1111/jcpe.13795. Epub 2023 Mar 5.
- Background: PubMed 40217911Ickroth A, Christiaens V, Pitman J, Cosyn J. A Systematic Review on Immediate Implant Placement in Intact Versus Non-Intact Alveolar Sockets. J Clin Med. 2025 Apr 3;14(7):2462. doi: 10.3390/jcm14072462.
- Background: PubMed 16307569Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
- Background: PubMed 15367183Botticelli D, Berglundh T, Lindhe J. Hard-tissue alterations following immediate implant placement in extraction sites. J Clin Periodontol. 2004 Oct;31(10):820-8. doi: 10.1111/j.1600-051X.2004.00565.x.
- Background: PubMed 27620655Assaf JH, Assaf DD, Antoniazzi RP, Osorio LB, Franca FM. Correction of Buccal Dehiscence During Immediate Implant Placement Using the Flapless Technique: A Tomographic Evaluation. J Periodontol. 2017 Feb;88(2):173-180. doi: 10.1902/jop.2016.160276. Epub 2016 Sep 13.
- Background: PubMed 27861667Barone A, Toti P, Marconcini S, Derchi G, Saverio M, Covani U. Esthetic Outcome of Implants Placed in Fresh Extraction Sockets by Clinicians with or without Experience: A Medium-Term Retrospective Evaluation. Int J Oral Maxillofac Implants. 2016 Nov/Dec;31(6):1397-1406. doi: 10.11607/jomi.4646.
- Individual participant dataSharing planned: Undecided. If the data can be included in a meta-analysis upon request by the authors, they can be transferred
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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.
2 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 placement in people with Bone Resorption, run by University Ghent at 2 sites in Belgium.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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 Véronique Christiaens, Phd (09/332 40 17, vchristi.christiaens@UGent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Buccal bone thickness -1 (mm) (time frame: moment of enrollment and 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07080710, which also lists 6 linked publications.
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 2025.