Complications Clinical Trial
Official title:
Cost Effectiveness of Various Implant Placement Protocols in the Esthetic Zone - a Non-randomized Controlled Trial
Loss of teeth in the anterior upper jaw significantly affects both well-being and chewing function. Nowadays, dental implants are the treatment of choice for replacing missing teeth with fixed dental prostheses and are often placed in the anterior upper jaw. Depending on various patient-related factors, protocols for the placement of dental implants involve the following time points after tooth extraction: 1. On the same day (immediate implantation) 2. After 1-4 months (early implantation) 3. After more than 4 months (late implantation). The different treatment protocols have been investigated over long periods. The choice of the individually suitable treatment protocol for dental implantation depends on many factors and is of utmost importance in order to achieve the best possible treatment outcomes. Selecting an inappropriate treatment protocol would otherwise result in an increased risk of failure. After decades of research and development in dental implantology, an expert association (International Team for Implantology, ITI) published an evidence-based decision management tool in 2022. This decision management tool assists dentists in choosing the individually suitable implant treatment protocol for single-tooth replacement in the upper jaw. A structured examination of the tooth to be extracted allows to classify the situation and select the most suitable treatment protocol for the individual situation. The treatment protocols differ in terms of time and material requirements, which are associated with different costs. There is limited data about the cost-effectiveness of these treatment protocols. The present study aims to assess how the costs of the three treatment protocols differ in relation to treatment success.
Status | Not yet recruiting |
Enrollment | 160 |
Est. completion date | January 1, 2037 |
Est. primary completion date | January 1, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - Age = 20 years - Willingness and ability to sign informed consent (Appendix Informed Consent Form) and to participate in the study - Plaque index according to Silness and Loe of < 35% - Presence of a single tooth (FDI positions 15 - 25) that has to be extracted - Sufficient vertical interocclusal space for the placement of an implant crown (FDI regions 13-23: 3 mm, FDI regions 15, 14, 24, 25: 6 mm) - Ridge height sufficient for the placement of a = 8 mm-long implant - Sufficient ridge width for the placement of a 2.9 mm diameter implant (min. 5 mm) 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 (pregnancy tests will be applied; see chapter 6.5) - Intention to become pregnant between inclusion and implant loading - Heavy smoking habit with = 10 cig/d - Allergy to titanium - Severe bruxism or clenching habits, present oro-facial pain - Insufficient ridge width/height for the study implant |
Country | Name | City | State |
---|---|---|---|
Switzerland | Klinik für Oralchirurgie und Stomatologie, zmk Bern, Universität Bern | Bern |
Lead Sponsor | Collaborator |
---|---|
University of Bern |
Switzerland,
Buser D, Chappuis V, Belser UC, Chen S. Implant placement post extraction in esthetic single tooth sites: when immediate, when early, when late? Periodontol 2000. 2017 Feb;73(1):84-102. doi: 10.1111/prd.12170. — View Citation
Buser D, Chappuis V, Kuchler U, Bornstein MM, Wittneben JG, Buser R, Cavusoglu Y, Belser UC. Long-term stability of early implant placement with contour augmentation. J Dent Res. 2013 Dec;92(12 Suppl):176S-82S. doi: 10.1177/0022034513504949. Epub 2013 Oct 24. — View Citation
Buser D, Janner SF, Wittneben JG, Bragger U, Ramseier CA, Salvi GE. 10-year survival and success rates of 511 titanium implants with a sandblasted and acid-etched surface: a retrospective study in 303 partially edentulous patients. Clin Implant Dent Relat Res. 2012 Dec;14(6):839-51. doi: 10.1111/j.1708-8208.2012.00456.x. — View Citation
Ducommun J, El Kholy K, Rahman L, Schimmel M, Chappuis V, Buser D. Analysis of trends in implant therapy at a surgical specialty clinic: Patient pool, indications, surgical procedures, and rate of early failures-A 15-year retrospective analysis. Clin Oral Implants Res. 2019 Nov;30(11):1097-1106. doi: 10.1111/clr.13523. Epub 2019 Aug 30. — View Citation
Tonetti MS, Cortellini P, Graziani F, Cairo F, Lang NP, Abundo R, Conforti GP, Marquardt S, Rasperini G, Silvestri M, Wallkamm B, Wetzel A. Immediate versus delayed implant placement after anterior single tooth extraction: the timing randomized controlled clinical trial. J Clin Periodontol. 2017 Feb;44(2):215-224. doi: 10.1111/jcpe.12666. Epub 2017 Jan 31. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment costs | Overall treatment costs for implant placement using three implant placement protocols | From enrollment to the 1 year follow-up | |
Primary | Implant survival rates | Subordinate/Descriptive primary outcome: implant survival rates | From enrollment to the 1 year follow-up | |
Secondary | Implant success | 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 | From enrollment to the 10 year follow-up | |
Secondary | Frequency of application of the various types of implant placement protocols | The frequency of application of the various types of implant placement (immediate, early, late), when applying the inclusion-criteria of a decision management tool | From enrollment to the end of treatment at 8 weeks | |
Secondary | Complication rates | Biological/technical/mechanical complication rates as defined by (Salvi et al., 2009; Schwarz et al., 2018) | From enrollment to the 10 year follow-up | |
Secondary | Esthetic outcomes | Esthetic outcomes by evaluating standardized digital photographs using pink/white esthetic scores | From enrollment to the 10 year follow-up | |
Secondary | Patient-centered outcomes | Patient-centered outcomes: placement protocol-related satisfaction (visual analogue scale (VAS)-based questionnaire) | From enrollment to the 10 year follow-up | |
Secondary | Accuracy of implant position | Accuracy of the final implant position compared of computer-assisted implant placements compared to the virtually pre-operatively planned implant position by superimposition of intraoral scans | From enrollment to the end of treatment at 8 weeks | |
Secondary | Soft tissue stability | Long term stability of the soft tissue dimensions utilizing digital imaging | From enrollment to the 10 year follow-up | |
Secondary | Hard tissue stability | Stability of the facial bone augmentation after implant placement using digital imaging | From enrollment to the 10 year follow-up | |
Secondary | Crestal Bone Levels | Mesial and distal implant bone level changes using standardized and digitized peri-apical radiographs | From enrollment to the 10 year follow-up |
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