Comparing immediate vs. delayed placement of dental crowns on implants after tooth extraction

Influence of the Implant Loading Protocol on Implant Survival in Early Placed Single-tooth Implants in Mandibular First Molar Sites Using Computer-assisted Implant Surgery: A Randomized Clinical Trial (RCT).

This study is testing whether putting a dental crown on an implant right after a tooth extraction works better than waiting four weeks for people who need a lower first molar replaced.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: University of Bern (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Bern and 1 other locations)
• Trial ID: NCT04319042 on ClinicalTrials.gov

What this trial studies

This study involves participants who need a lower first molar extracted and replaced with a dental implant. After the extraction, the implant will be placed 12-16 weeks later, with half of the participants receiving an artificial tooth immediately and the other half receiving it four weeks later. The study aims to compare the success rates and tissue health between these two loading protocols using modern implant techniques. The goal is to provide evidence for the effectiveness of immediate loading in dental implant procedures.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 and older who require extraction of a lower first molar and meet specific dental health criteria.

Not a fit: Patients with conditions that interfere with wound healing or those who cannot maintain adequate oral hygiene may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve patient outcomes by providing evidence for faster restoration of dental function after tooth extraction.

How similar studies have performed: Previous studies have shown promising results with similar immediate and early loading approaches in dental implant procedures.

Eligibility 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% \[26\]
* 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:

* 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
* Intention to become pregnant between inclusion and implant loading
* Heavy smoking habit with ≥ 10 cig/d
* Severe bruxism or clenching habits, present oro-facial pain
* Insufficient ridge width/height for the study implant
* Defect of any alveolar wall (secondary exclusion criterion at tooth extraction)
* ISQ \< 70 (secondary exclusion criterion for Group A at implant placement, for Group B at loading visit)

Where this trial is running

Bern and 1 other locations

• Klinik für Oralchirurgie und Stomatologie — Bern, Switzerland (Recruiting)
• Klinik für rekonstruktive Zahnmedizin und Gerodontologie — Bern, Switzerland (Recruiting)

Study contacts

• Principal investigator: Simone FM Janner, PD Dr. — University of Bern
• Study coordinator: Simone FM Janner, PD Dr.

Conditions Lower Molar Requiring Extraction