NCT04319042 Effect of Placing the Implant Crown on the Implant on the Same Day as the Implant vs. 4 Weeks Later.
| NCT ID | NCT04319042 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Bern |
| Condition | Lower Molar Requiring Extraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2021-04-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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)
Contact & Investigator
Simone FM Janner, PD Dr.
PRINCIPAL INVESTIGATOR
University of Bern
Frequently Asked Questions
Who can join the NCT04319042 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Lower Molar Requiring Extraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04319042 currently recruiting?
Yes, NCT04319042 is actively recruiting participants. Contact the research team at ueberweiser.chir@zmk.unibe.ch for enrollment information.
Where is the NCT04319042 trial being conducted?
This trial is being conducted at Bern, Switzerland, Bern, Switzerland.
Who is sponsoring the NCT04319042 clinical trial?
NCT04319042 is sponsored by University of Bern. The principal investigator is Simone FM Janner, PD Dr. at University of Bern. The trial plans to enroll 100 participants.