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Esthetic ZonePhase 4NCT05940662

Cost Effectiveness of Various Implant Placement Protocols in the Esthetic Zone

A Phase 4 study testing Immediate Implant Placement, Early Implant Placement and Late Implant Placement in people with Esthetic Zone and Single Tooth Lost, run by University of Bern at 1 site in Switzerland.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Immediate Implant Placement, Early Implant Placement and Late Implant Placement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteSwitzerland
Study dates
1 Jan 2029to 1 Jan 2040
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Klinik für Oralchirurgie und Stomatologie, zmk Bern, Universität Bern

    Bern, 3010

Other trials in Switzerland

About this study

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:

Read more
  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.

Read the 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.

Being tested
Immediate Implant Placement, Early Implant Placement, Late Implant Placement
Keywords
Dental implant, Digital image processing, Bone regeneration, Clinical study, Tooth extraction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immediate Implant PlacementProcedure or surgery

    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 PlacementProcedure or surgery

    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 PlacementProcedure or surgery

    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).

Study groups in NCT05940662
Study groupRoleWhat they receive
Immediate Implant PlacementExperimentalImmediate implant placement 1. 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. 2. After a healing period of at least 8 weeks, implant reopening takes place (conventional loading protocol).
Receives: Procedure: Immediate Implant Placement
Early Implant PlacementExperimentalEarly implant placement 1. 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. 2. 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. 3. After a healing period of at least 8 weeks, implant reopening takes place (conventional loading protocol).
Receives: Procedure: Early Implant Placement
Late Implant PlacementActive comparatorLate implant placement 1. 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. 2. 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. 3. After a healing period of at least 8 weeks, implant reopening takes place (conventional loading protocol).
Receives: Procedure: Late Implant Placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment costs

    Overall treatment costs for implant placement using three implant placement protocols

    Measured: From enrollment to the 1 year follow-up

  2. Implant survival rates

    Subordinate/Descriptive primary outcome: implant survival rates

    Measured: From enrollment to the 1 year follow-up

Secondary outcomes (9)
  1. 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

    Measured: From enrollment to the 10 year follow-up

  2. 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

    Measured: From enrollment to the end of treatment at 8 weeks

  3. Complication rates

    Biological/technical/mechanical complication rates as defined by (Salvi et al., 2009; Schwarz et al., 2018)

    Measured: From enrollment to the 10 year follow-up

  4. Esthetic outcomes

    Esthetic outcomes by evaluating standardized digital photographs using pink/white esthetic scores

    Measured: From enrollment to the 10 year follow-up

  5. Patient-centered outcomes

    Patient-centered outcomes: placement protocol-related satisfaction (visual analogue scale (VAS)-based questionnaire)

    Measured: From enrollment to the 10 year follow-up

  6. 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

    Measured: From enrollment to the end of treatment at 8 weeks

  7. Soft tissue stability

    Long term stability of the soft tissue dimensions utilizing digital imaging

    Measured: From enrollment to the 10 year follow-up

  8. Hard tissue stability

    Stability of the facial bone augmentation after implant placement using digital imaging

    Measured: From enrollment to the 10 year follow-up

  9. Crestal Bone Levels

    Mesial and distal implant bone level changes using standardized and digitized peri-apical radiographs

    Measured: From enrollment to the 10 year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2023
  2. Study start1 Jan 2029 (estimated)
  3. Primary completion1 Jan 2032 (estimated)
  4. Study completion1 Jan 2040 (estimated)

Why it stopped: Funding difficulties

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05940662
Sponsor's protocol ID
2023-00879
Other IDs
2023
Status last verified
Sep 2025
First submitted
4 Jul 2023
Last updated
23 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: After publication some additional non-published data can be given upon reasonable request.

Publications

  • 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.

    PubMed 27978602
  • 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.

    PubMed 31400242
  • 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.

    PubMed 22897683
  • 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.

    PubMed 24158332
  • 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.

    PubMed 28000278

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Immediate Implant Placement, Early Implant Placement and Late Implant Placement in people with Esthetic Zone and Single Tooth Lost, run by University of Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment costs (time frame: From enrollment to the 1 year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05940662, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.

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