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In this study, participants with one lower first molar that require removal and replacement using dental implants will be enrolled. The implant will be inserted 12-16 weeks after tooth extraction and restored either immediately with an artificial tooth (fixed implant crown) in 50% of the cases or 4 weeks later in the remainder 50%. Immediate and early loading will be compared and the investigators expect no difference in terms of implant success and health of the tissue around the implant.
Background
Dental implants placed between 12 and 16 weeks after tooth loss are a well-documented treatment option. Placing the artificial tooth (implant crown) on the implant the same day (immediate loading) or approximately 4 weeks after implant placement (early loading) are also treatment options with good scientific documentation. Computer-assisted implant surgery (sCAIS) and modern implant materials/surfaces increase treatment predictability and success in this context.
Clinical relevance
The timing of implant placement post-extraction and subsequent implant loading cannot be separated in modern implant therapy any longer. At the "Sixth ITI Consensus Conference" in Amsterdam, it was concluded that the clinical evidence and documentation of early implant placement combined with immediate or early implant loading in partially edentulous patients is currently insufficiently documented. However, this treatment protocol seems to be widely applied in daily practice. The planned study is designed to provide evidence for the application of early implant placement with partial bone-healing and either an immediate or an early loading protocol.
Hypothesis/Specific aims
H0: "Early placed single tooth implants by means of static computer-assisted implant surgery (sCAIS) in mandibular first molar sites with immediately loaded provisionals, show a survival rate comparable to early placed implants with an early loading protocol." Secondary parameters to be evaluated will be the prosthetic survival/ success, patient-centered outcomes (PROs), clinical peri-implant conditions, bone-level changes, alteration of peri-implant soft-tissue dimensions and the accuracy of digital implant planning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Loading | Active Comparator | Group A. The implant receives an artificial tooth the same day as it is placed. |
|
| Early Loading | Active Comparator | Group B. The implant receives an artificial tooth 4 weeks after placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate Loading | Procedure | The implant receives an artificial tooth the same day as it is placed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survival | Number of implants from both groups (i.e. immediate loading vs. early loading) fulfilling the criteria of survival and success after 12 months. The criteria are:
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Prosthetic Success | Esthetics and correct function of the implant prosthetic will be analyzed by means of palpation, inspection and probing. Any prosthetic complication, e.g. chipping, screw loosening will be recorded. | 10 years |
| Patient's satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simone FM Janner, PD Dr. | Contact | +41316322566 | ueberweiser.chir@zmk.unibe.ch | |
| Samir Abou-Ayash, Dr.med.dent. | Contact | +41316322586 | ueberweiser.chir@zmk.unibe.ch |
| Name | Affiliation | Role |
|---|---|---|
| Simone FM Janner, PD Dr. | University of Bern | Principal Investigator |
| Samir Abou-Ayash, Dr.med.dent. | University of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Oralchirurgie und Stomatologie | Recruiting | Bern | Canton of Bern | 3010 | Switzerland |
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| ID | Term |
|---|---|
| D057893 | Immediate Dental Implant Loading |
| ID | Term |
|---|---|
| D003758 | Dental Implantation, Endosseous |
| D003757 | Dental Implantation |
| D013516 | Oral Surgical Procedures, Preprosthetic |
| D019647 | Oral Surgical Procedures |
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| Early Loading | Procedure | The implant receives an artificial tooth 4 weeks after placement. |
|
Patient's satisfaction with the treatment result will be analyzed by means of questions (both oral and written, using validated questionnaires) |
| 10 years |
| Clinical peri-implant soft tissue dimensions | Probing depth of the soft tissue surrounding the implant will be assessed using palpation, inspection and a periodontal probe. | 10 years |
| Crestal bone level | Crestal bone-level changes will be assessed in the follow-up radiographs that are taken routinely after any implant treatment, using a dedicated imaging software. | 10 years |
| Accuracy of digital implant planning | The difference between digitally planned and real/final implant position will be analyzed by superimposing the digitized final impression and the digital preoperative planning with the dedicated software. No additional exposure to radiation or additional impressions will be necessary. | 12 months |
| Klinik für rekonstruktive Zahnmedizin und Gerodontologie | Recruiting | Bern | Canton of Bern | 3010 | Switzerland |
|
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D003813 | Dentistry |
| D011476 | Prosthodontics |