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Cost Effectiveness of Various Implant Placement Protocols in the Esthetic Zone

Primary Purpose

Esthetic Zone, Single Tooth Lost, Accuracy of Dental Implants

Status
Not yet recruiting
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Immediate Implant Placement
Early Implant Placement
Late Implant Placement
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esthetic Zone focused on measuring Dental implant, Digital image processing, Bone regeneration, Clinical study, Tooth extraction

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik für Oralchirurgie und Stomatologie, zmk Bern, Universität Bern

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Immediate Implant Placement

Early Implant Placement

Late Implant Placement

Arm Description

Immediate implant placement The extraction of the failing tooth will be carried out. Subsequently, immediate implant placement and bone grafting of the intra-alveolar space by the means of a well-documented xenogeneic bone substitute will be carried out, will be conducted all in one single surgical intervention. After a healing period of at least 8 weeks, implant reopening takes place (conventional loading protocol).

Early implant placement The extraction of the failing tooth will be carried out. Within a healing period of 4-16 weeks, the extraction socket will be completely covered by soft tissues. Implant placement and bone grafting by the means of guided bone regeneration using locally harvested autogenous bone and a well-documented xenogeneic bone substitute will be carried out. After a healing period of at least 8 weeks, implant reopening takes place (conventional loading protocol).

Late implant placement The extraction of the failing tooth and a socket grafting procedure using a well-documented xenogeneic bone substitute will be carried out. Within a healing period of at least 16 weeks, the extraction socket will be completely covered by soft tissues and complete bone healing is anticipated. Implant placement and bone grafting by the means of guided bone regeneration using locally harvested autogenous bone and a well-documented xenogeneic bone substitute will be carried out. After a healing period of at least 8 weeks, implant reopening takes place (conventional loading protocol).

Outcomes

Primary Outcome Measures

Treatment costs
Overall treatment costs for implant placement using three implant placement protocols
Implant survival rates
Subordinate/Descriptive primary outcome: implant survival rates

Secondary Outcome Measures

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
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
Complication rates
Biological/technical/mechanical complication rates as defined by (Salvi et al., 2009; Schwarz et al., 2018)
Esthetic outcomes
Esthetic outcomes by evaluating standardized digital photographs using pink/white esthetic scores
Patient-centered outcomes
Patient-centered outcomes: placement protocol-related satisfaction (visual analogue scale (VAS)-based questionnaire)
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
Soft tissue stability
Long term stability of the soft tissue dimensions utilizing digital imaging
Hard tissue stability
Stability of the facial bone augmentation after implant placement using digital imaging
Crestal Bone Levels
Mesial and distal implant bone level changes using standardized and digitized peri-apical radiographs

Full Information

First Posted
July 4, 2023
Last Updated
July 4, 2023
Sponsor
University of Bern
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1. Study Identification

Unique Protocol Identification Number
NCT05940662
Brief Title
Cost Effectiveness of Various Implant Placement Protocols in the Esthetic Zone
Official Title
Cost Effectiveness of Various Implant Placement Protocols in the Esthetic Zone - a Non-randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
January 1, 2027 (Anticipated)
Study Completion Date
January 1, 2037 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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: On the same day (immediate implantation) After 1-4 months (early implantation) 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esthetic Zone, Single Tooth Lost, Accuracy of Dental Implants, Dimensional Changes, Patient Reported Outcome Measures, Implant Survival and Success, Cost-effectiveness, Cost-Benefit Analysis, Complications, Frequency of Treatment Protocol, Single Tooth Dental Implant
Keywords
Dental implant, Digital image processing, Bone regeneration, Clinical study, Tooth extraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate Implant Placement
Arm Type
Experimental
Arm Description
Immediate implant placement The extraction of the failing tooth will be carried out. Subsequently, immediate implant placement and bone grafting of the intra-alveolar space by the means of a well-documented xenogeneic bone substitute will be carried out, will be conducted all in one single surgical intervention. After a healing period of at least 8 weeks, implant reopening takes place (conventional loading protocol).
Arm Title
Early Implant Placement
Arm Type
Experimental
Arm Description
Early implant placement The extraction of the failing tooth will be carried out. Within a healing period of 4-16 weeks, the extraction socket will be completely covered by soft tissues. Implant placement and bone grafting by the means of guided bone regeneration using locally harvested autogenous bone and a well-documented xenogeneic bone substitute will be carried out. After a healing period of at least 8 weeks, implant reopening takes place (conventional loading protocol).
Arm Title
Late Implant Placement
Arm Type
Active Comparator
Arm Description
Late implant placement The extraction of the failing tooth and a socket grafting procedure using a well-documented xenogeneic bone substitute will be carried out. Within a healing period of at least 16 weeks, the extraction socket will be completely covered by soft tissues and complete bone healing is anticipated. Implant placement and bone grafting by the means of guided bone regeneration using locally harvested autogenous bone and a well-documented xenogeneic bone substitute will be carried out. After a healing period of at least 8 weeks, implant reopening takes place (conventional loading protocol).
Intervention Type
Procedure
Intervention Name(s)
Immediate Implant Placement
Intervention Description
The extraction of the failing tooth will be carried out. Subsequently, immediate implant placement and bone grafting of the intra-alveolar space by the means of a well-documented xenogeneic bone substitute will be carried out, will be conducted all in one single surgical intervention. After a healing period of at least 8 weeks, implant reopening takes place (conventional loading protocol).
Intervention Type
Procedure
Intervention Name(s)
Early Implant Placement
Intervention Description
The extraction of the failing tooth will be carried out. Within a healing period of 4-16 weeks, the extraction socket will be completely covered by soft tissues. Implant placement and bone grafting by the means of guided bone regeneration using locally harvested autogenous bone and a well-documented xenogeneic bone substitute will be carried out. After a healing period of at least 8 weeks, implant reopening takes place (conventional loading protocol).
Intervention Type
Procedure
Intervention Name(s)
Late Implant Placement
Intervention Description
The extraction of the failing tooth and a socket grafting procedure using a well-documented xenogeneic bone substitute will be carried out. Within a healing period of at least 16 weeks, the extraction socket will be completely covered by soft tissues and complete bone healing is anticipated. Implant placement and bone grafting by the means of guided bone regeneration using locally harvested autogenous bone and a well-documented xenogeneic bone substitute will be carried out. After a healing period of at least 8 weeks, implant reopening takes place (conventional loading protocol).
Primary Outcome Measure Information:
Title
Treatment costs
Description
Overall treatment costs for implant placement using three implant placement protocols
Time Frame
From enrollment to the 1 year follow-up
Title
Implant survival rates
Description
Subordinate/Descriptive primary outcome: implant survival rates
Time Frame
From enrollment to the 1 year follow-up
Secondary Outcome Measure Information:
Title
Implant success
Description
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
Time Frame
From enrollment to the 10 year follow-up
Title
Frequency of application of the various types of implant placement protocols
Description
The frequency of application of the various types of implant placement (immediate, early, late), when applying the inclusion-criteria of a decision management tool
Time Frame
From enrollment to the end of treatment at 8 weeks
Title
Complication rates
Description
Biological/technical/mechanical complication rates as defined by (Salvi et al., 2009; Schwarz et al., 2018)
Time Frame
From enrollment to the 10 year follow-up
Title
Esthetic outcomes
Description
Esthetic outcomes by evaluating standardized digital photographs using pink/white esthetic scores
Time Frame
From enrollment to the 10 year follow-up
Title
Patient-centered outcomes
Description
Patient-centered outcomes: placement protocol-related satisfaction (visual analogue scale (VAS)-based questionnaire)
Time Frame
From enrollment to the 10 year follow-up
Title
Accuracy of implant position
Description
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
Time Frame
From enrollment to the end of treatment at 8 weeks
Title
Soft tissue stability
Description
Long term stability of the soft tissue dimensions utilizing digital imaging
Time Frame
From enrollment to the 10 year follow-up
Title
Hard tissue stability
Description
Stability of the facial bone augmentation after implant placement using digital imaging
Time Frame
From enrollment to the 10 year follow-up
Title
Crestal Bone Levels
Description
Mesial and distal implant bone level changes using standardized and digitized peri-apical radiographs
Time Frame
From enrollment to the 10 year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clemens Raabe, Dr. med. dent.
Phone
+41 31 684 06 10
Email
clemens.raabe@unibe.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Vivianne Chappuis, Prof. Dr. med. dent.
Phone
+41 31 684 06 10
Email
vivianne.chappuis@unibe.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clemens Raabe
Organizational Affiliation
Klinik für Oralchirurgie und Stomatologie, Universität Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Oralchirurgie und Stomatologie, zmk Bern, Universität Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clemens Raabe, Dr. med. dent.
Phone
+41 31 684 06 10
Email
clemens.raabe@unibe.ch
First Name & Middle Initial & Last Name & Degree
Vivianne Chappuis, Prof. Dr. med. dent.
Phone
+41 31 684 06 10
Email
vivianne.chappuis@unibe.ch
First Name & Middle Initial & Last Name & Degree
Clemens Raabe, Dr. med. dent.

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
After publication some additional non-published data can be given upon reasonable request.
Citations:
PubMed Identifier
27978602
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.
Results Reference
background
PubMed Identifier
31400242
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.
Results Reference
background
PubMed Identifier
22897683
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.
Results Reference
background
PubMed Identifier
24158332
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.
Results Reference
background
PubMed Identifier
28000278
Citation
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.
Results Reference
background
Links:
URL
https://academy.iti.org/academy/clinical-applications/iti-decision-tree
Description
ITI Decision management tool

Learn more about this trial

Cost Effectiveness of Various Implant Placement Protocols in the Esthetic Zone

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