Immediate loading of dental implants for replacing a molar
Influence of the Implant Loading Protocol on Implant Survival in Early Placed Single-tooth Implants in Mandibular Posterior Sites Using Computer-assisted Implant Surgery: A Randomized Clinical Trial (RCT)
NA · University of Bern · NCT05409287
This study tests whether putting in a temporary dental implant right after removing a molar works better than waiting a little while before doing the same.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | University of Bern (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Bern) |
| Trial ID | NCT05409287 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of immediate versus early loading protocols for dental implants placed after the extraction of a mandibular first molar. Participants will undergo ridge preservation using a xenogeneic bone substitute, followed by a 12-week healing period before implant placement. They will be randomized into two groups: one receiving immediate loading of a provisional implant and the other receiving early loading without additional preparation. The study will adhere to CONSORT guidelines and utilize advanced imaging and digital planning techniques.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 and older who require extraction of a mandibular first molar and subsequent implant placement.
Not a fit: Patients with uncontrolled diabetes, immunosuppression, or other conditions affecting wound healing may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster recovery and improved outcomes for patients needing dental implants.
How similar studies have performed: Previous studies have shown promise with immediate loading protocols in dental implants, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 20 years * Willingness to sign informed consent and to participate in the study * Plaque index according to Silness and Loe of \< 35% \[26\] At site level: * Presence of a mandibular first molar that has to be extracted * Sufficient vertical interocclusal space for the placement of an implant crown (7 mm) * Presence of an opposing natural or artificial tooth * Ridge height sufficient for the placement of a ≥ 10 mm-long implant * Sufficient ridge width for the placement of a 4.1mm diameter implant Exclusion Criteria: At patient level: * Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance to the protocol * Any disorder that would interfere with wound healing or represent a contraindication for implant surgery such as, but not limited to, uncontrolled diabetes or conditions resulting in or requiring immunosuppression, radiation, chemotherapy, frequent use of antibiotics or antiresorptive medication such as bisphosphonates * Pregnancy or lactation * Heavy smoking habit with ≥ 10 cig/d * Severe bruxism or clenching habits, present oro-facial pain at site level * Insufficient ridge width/height for the study implant
Where this trial is running
Bern
- Department of Reconstructive Dentistry, University of Bern — Bern, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Samir Abou-Ayash, PD Dr. — University of Bern
- Study coordinator: Samir Abou-Ayash, PD Dr.
- Email: samir.abou-ayash@unibe.ch
- Phone: +41 31 632 87 05
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Partial Edentulism Class 3