Effect of Placing the Implant Crown on the Implant on the Same Day as the Implant vs. 4 Weeks Later.
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).
1 other identifier
interventional
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2020
CompletedFirst Posted
Study publicly available on registry
March 24, 2020
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2033
ExpectedFebruary 18, 2026
February 1, 2026
5.1 years
March 20, 2020
February 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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: * 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
12 months
Secondary Outcomes (5)
Prosthetic Success
10 years
Patient's satisfaction
10 years
Clinical peri-implant soft tissue dimensions
10 years
Crestal bone level
10 years
Accuracy of digital implant planning
12 months
Study Arms (2)
Immediate Loading
ACTIVE COMPARATORGroup A. The implant receives an artificial tooth the same day as it is placed.
Early Loading
ACTIVE COMPARATORGroup B. The implant receives an artificial tooth 4 weeks after placement.
Interventions
The implant receives an artificial tooth the same day as it is placed.
The implant receives an artificial tooth 4 weeks after placement.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Insufficient ridge width/height for the study implant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Klinik für Oralchirurgie und Stomatologie
Bern, 3010, Switzerland
Klinik für rekonstruktive Zahnmedizin und Gerodontologie
Bern, 3010, Switzerland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simone FM Janner, PD Dr.
University of Bern
- PRINCIPAL INVESTIGATOR
Samir Abou-Ayash, Dr.med.dent.
University of Bern
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2020
First Posted
March 24, 2020
Study Start
April 1, 2021
Primary Completion
May 1, 2026
Study Completion (Estimated)
May 1, 2033
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share