NCT05940662

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:

  1. 1.On the same day (immediate implantation)
  2. 2.After 1-4 months (early implantation)
  3. 3.After more than 4 months (late implantation).

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
134mo left

Started Jan 2029

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
5.5 years until next milestone

Study Start

First participant enrolled

January 1, 2029

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2032

8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2040

Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

3 years

First QC Date

July 4, 2023

Last Update Submit

September 17, 2025

Conditions

Esthetic ZoneSingle Tooth LostAccuracy of Dental ImplantsDimensional ChangesPatient Reported Outcome MeasuresImplant Survival and SuccessCost-effectivenessCost-Benefit AnalysisComplicationsFrequency of Treatment ProtocolSingle Tooth Dental Implant

Keywords

Dental implantDigital image processingBone regenerationClinical studyTooth extraction

Outcome Measures

Primary Outcomes (2)

  • Treatment costs

    Overall treatment costs for implant placement using three implant placement protocols

    From enrollment to the 1 year follow-up

  • Implant survival rates

    Subordinate/Descriptive primary outcome: implant survival rates

    From enrollment to the 1 year follow-up

Secondary Outcomes (9)

  • Implant success

    From enrollment to the 10 year follow-up

  • Frequency of application of the various types of implant placement protocols

    From enrollment to the end of treatment at 8 weeks

  • Complication rates

    From enrollment to the 10 year follow-up

  • Esthetic outcomes

    From enrollment to the 10 year follow-up

  • Patient-centered outcomes

    From enrollment to the 10 year follow-up

  • +4 more secondary outcomes

Study Arms (3)

Immediate Implant Placement

EXPERIMENTAL

Immediate 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).

Procedure: Immediate Implant Placement

Early Implant Placement

EXPERIMENTAL

Early 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).

Procedure: Early Implant Placement

Late Implant Placement

ACTIVE COMPARATOR

Late 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).

Procedure: Late Implant Placement

Interventions

Immediate Implant PlacementPROCEDURE

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).

Immediate Implant Placement
Early Implant PlacementPROCEDURE

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).

Early Implant Placement
Late Implant PlacementPROCEDURE

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).

Late Implant Placement

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Oralchirurgie und Stomatologie, zmk Bern, Universität Bern

Bern, 3010, Switzerland

Location

Related Publications (5)

  • 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.

    PMID: 27978602BACKGROUND

  • 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.

    PMID: 31400242BACKGROUND

  • 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.

    PMID: 22897683BACKGROUND

  • 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.

    PMID: 24158332BACKGROUND

  • 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.

    PMID: 28000278BACKGROUND

Study Officials

  • Clemens Raabe

    Klinik für Oralchirurgie und Stomatologie, Universität Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2023

First Posted

July 11, 2023

Study Start (Estimated)

January 1, 2029

Primary Completion (Estimated)

January 1, 2032

Study Completion (Estimated)

January 1, 2040

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

After publication some additional non-published data can be given upon reasonable request.

Locations

CH(1)