Cost Effectiveness of Various Implant Placement Protocols in the Esthetic Zone

Complications Clinical Trial

Official title: Cost Effectiveness of Various Implant Placement Protocols in the Esthetic Zone - a Non-randomized Controlled Trial

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Tooth loss in the visible esthetic zone of the anterior maxilla strongly impairs both patients' psychosocial well-being and masticatory function with a high demand for tooth replacement. Therefore, single tooth replacement by dental implant therapy is a very frequent indication in the esthetic zone, being corroborated with high expectations on esthetic parameters of the treatment outcomes. Depending on local, systemic, surgical, and prosthetic factors, dental implant placement can be carried out utilizing different protocols according to the time after tooth extraction: immediate (same day, fresh extraction socket), early (1-4 months, soft tissue healing), or late (more than 4 months after tooth extraction, bone healing). Insufficient weighting of risk factors may lead to the selection of a too risky implant placement protocol, which may cause implant failures in the esthetic zone. Therefore, the appropriate selection of timepoint and corresponding surgical protocol for implant placement are of outmost importance to achieve satisfying and predictable long-term treatment outcomes in the esthetic zone. To guide clinicians in the choice of the individually appropriate placement protocol for single tooth replacement in the esthetic zone, an evidence-based decision management tool was developed and released by the International Team for Implantology (ITI) in 2022 after decades of research and developments in dental implantology. The flowchart includes radiographic and clinical pre- and intraoperative assessments when extracting a failing tooth, to apply defined inclusion/exclusion criteria to the individual case and define the indicated implant placement protocol aiming at high implant survival and success rates. Besides the timepoint of implant placement, the implant placement protocols involve differing amount of surgeries (immediate: 1-2, early: 3, late: 3-4), techniques for tissue augmentation including varying amount of biomaterials (immediate: socket grafting (SG), early: guided bone regeneration (GBR), late: SG and GBR) and estimated overall clinical visits (immediate: minimum 4, early: minimum 5, late: minimum 6). All these factors contribute to the operating costs of a private practice/dental clinic in implant dentistry, with the majority of costs being composed of material costs and the procedural time involved. To date, there is a lack of data about the cost effectiveness of dental implant placement using varying implant placement protocols. Therefore, this study is designed to primarily evaluate the surgical costs in relation to the implant survival rates of implant placement procedures using various placement protocols as indicated by an evidence-based decision management tool. The secondary outcomes include the assessment of placement protocol frequency, biological/mechanical/technical complication rates and the long-term stability of regenerated tissues. ;

Related Conditions & MeSH terms

• Complications
• Cost-Benefit Analysis
• Cost-effectiveness
• Patient Reported Outcome Measures
• Single Tooth Dental Implant
• Single Tooth Lost
• Tooth Loss

• NCT number: NCT05940662
• Study type: Interventional
• Source: University of Bern
• Contact: Clemens Raabe, Dr. med. dent.
• Phone: +41 31 684 06 10
• Email: clemens.raabe@unibe.ch
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 1, 2024
• Completion date: January 1, 2037