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Recruiting Not applicable

Effect of Placing the Implant Crown on the Implant on the Same Day as the Implant vs. 4 Weeks Later.

NCT04319042 · tracked via the Priya Life Science Switzerland tracker
Phase
Not applicable
Started
2021-04-01
Last updated
2026-06-26

Condition(s) studied

Lower Molar Requiring Extraction

Investigational drug(s) / intervention(s)

Immediate LoadingEarly Loading

Immediate Loading: The implant receives an artificial tooth the same day as it is placed.

Early Loading: The implant receives an artificial tooth 4 weeks after placement.

Study 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

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Implant Survival — 12 months
    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: * Absence of persisting subjective discomfort such as pain, foreign body perception and or dysaesthesia (e. g. painful sensation) * Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if observed at two or more follow-up visits after the treatment with systemic antibiotics) * Absence of implant mobility on manual palpation * Absence of any continuous peri-implant radiolucency

Trial sites (2)

FacilityCityRegionStatus
Klinik für Oralchirurgie und Stomatologie Bern Canton of Bern Recruiting
Klinik für rekonstruktive Zahnmedizin und Gerodontologie Bern Canton of Bern Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04319042 on ClinicalTrials.gov ↗ ← All trials in Switzerland