Lower Molar Requiring Extraction Clinical Trial
Official title:
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).
| NCT number | NCT04319042 |
| Other study ID # | ITI 1455_2019 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 1, 2021 |
| Est. completion date | May 2033 |
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | May 2033 |
| Est. primary completion date | May 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Klinik für Oralchirurgie und Stomatologie | Bern | |
| Switzerland | Klinik für rekonstruktive Zahnmedizin und Gerodontologie | Bern |
| Lead Sponsor | Collaborator |
|---|---|
| University of Bern |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. | 10 years | |
| Secondary | Patient's satisfaction | Patient's satisfaction with the treatment result will be analyzed by means of questions (both oral and written, using validated questionnaires) | 10 years | |
| Secondary | 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. | 10 years | |
| Secondary | 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. | 10 years | |
| Secondary | Accuracy of digital implant planning | The difference between digitally planned and real/final implant position will be analyzed by superimposing the digitized final impression and the digital preoperative planning with the dedicated software. No additional exposure to radiation or additional impressions will be necessary. | 12 months |