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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Véronique Christiaens, Phd contact

09/332 40 17

vchristi.christiaens@UGent.be

Jan Cosyn, PhD contact

09/332 40 18

jan.cosyn@UGent.be

Belgium2 sites, 2 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

    Recruiting

Other trials in Belgium

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 groups in NCT07080710
Study groupRoleWhat they receive
Immediate implant placementExperimentalState 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. Peri-implant health

    Peri-implant health is clinically assessed on the basis of probing depth, bleeding on probing and plaque.

    Measured: 1-, 5-year

  6. 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.

  1. First posted23 Jul 2025
  2. Study start1 Jul 2025
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Feb 2032 (estimated)

Resources

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)
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 36843361
  • Ickroth 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 40217911
  • Furhauser 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 16307569
  • Botticelli 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 15367183
  • Assaf 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 27620655
  • Barone 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

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.

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