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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:
Researchers will compare treatment results in patients with intact bone sockets to those with damaged (non-intact) sockets.
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate implant placement | Experimental | State of the art immediate implant placement with socket grafting and soft tissue augmentation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate implant placement | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | moment of enrollment and 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | one week after surgery |
| Pink Esthetic Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Véronique Christiaens, Phd | Contact | 09/332 40 17 | vchristi.christiaens@UGent.be | |
| Jan Cosyn, PhD | Contact | 09/332 40 18 | jan.cosyn@UGent.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University | Recruiting | Ghent | East Flanders | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36843361 | Background | 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. | |
| 40217911 | Background | 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. |
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If the data can be included in a meta-analysis upon request by the authors, they can be transferred
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| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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Prospective cohort study
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As this prospective study concerns a surgical intervention, patients and treating clinicians can not be masked.
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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).
| 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. | 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. | 1-, 5-year |
| Peri-implant health | Peri-implant health is clinically assessed on the basis of probing depth, bleeding on probing and plaque. | 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. | enrollment, 1-year , 5-year |
| Bv Dr. Cosyn | Recruiting | Zottegem | East Flanders | 9620 | Belgium |
|
| 16307569 | Background | 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. |
| 15367183 | Background | 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. |
| 27620655 | Background | 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. |
| 27861667 | Background | 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. |