About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Immediate Loading
Procedure/SurgeryThe implant receives an artificial tooth the same day as it is placed.
Early Loading
Procedure/SurgeryThe implant receives an artificial tooth 4 weeks after placement.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Prosthetic Success
Esthetics and correct function of the implant prosthetic will be analyzed by means of palpation, inspection and probing. Any prosthetic complication, e.g. chipping, screw loosening will be recorded.
Patient's satisfaction
Patient's satisfaction with the treatment result will be analyzed by means of questions (both oral and written, using validated questionnaires)
Clinical peri-implant soft tissue dimensions
Probing depth of the soft tissue surrounding the implant will be assessed using palpation, inspection and a periodontal probe.
Crestal bone level
Crestal bone-level changes will be assessed in the follow-up radiographs that are taken routinely after any implant treatment, using a dedicated imaging software.
Sponsors and contacts
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