Two Implants Versus One Implant With a Cantilever - a Randomized Controlled Clinical Trial

NCT01649531 | Unknown

• 1 other identifier: 2012-0097
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to test whether there is a difference in the marginal bone level change between implants with and without cantilevers.

Conditions

Dental Implants

Outcome Measures

Primary Outcomes (1)

• radiographic bone level

  The primary endpoint of the study is the radiographic bone level 5 years after insertion.The bone level represents an indicator of the osseointegration and biological success of the implant.

  5 years

Secondary Outcomes (6)

• Radiographic bone level

  1, 3, 7, 10 years

• Implant survival and success

  1, 3, 5, 7, 10 years

• rate of technical complication

  1, 3, 5, 7, 10 years

• rate of biological complications

  1, 3, 5, 7, 10 years

• Soft tissue changes

  1, 3, 5, 7, 10 years

Study Arms (2)

Test group

ACTIVE COMPARATOR

1 Implant, to be placed in the position with greater vertical bone height with a mesial or distal cantilever.

Procedure: 1 Implant

Control group

ACTIVE COMPARATOR

2 Implants

Procedure: 2 Implants

Interventions

1 Implant PROCEDURE

Test group

2 Implants PROCEDURE

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male and female patients 18 years to 80 years of age
• no general medical condition which represents a contraindication to implant treatment
• two adjacent missing teeth in the maxilla or mandible in positions of premolars and molars
• at least one tooth present adjacent to the edentulous space
• indication for implant treatment is given
• at least 8 mm of vertical bone height in the mandible allowing for the placement of a 6 mm implant (2 mm safety distance to inferior alveolar nerve)
• at least 4 mm of vertical bone height in the maxilla
• signed informed consent after being informed

You may not qualify if:

• smoking of more than 15 cigarettes a day (clinical studies show an increased failure rate of implants in heavy smokers)
• poor oral hygiene after hygienic phase (Plaque Index over 30 %)
• active periodontal disease

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Center of Dental Medicine Clinic of Reconstructive Dentistry

Zurich, 8032, Switzerland

Location

Related Publications (2)

• Strauss FJ, Schiavon L, Naenni N, Kraus RD, Saenz-Ravello G, Muller N, Jung RE, Thoma DS. Cost Effectiveness of Two Short Implants Versus One Short Implant With a Cantilever in the Posterior Region: 7.5-Year Follow-Up of a Randomised Controlled Trial. J Clin Periodontol. 2025 Dec;52(12):1712-1724. doi: 10.1111/jcpe.70039. Epub 2025 Sep 21.

  PMID: 40976576 DERIVED

• Thoma DS, Wolleb K, Schellenberg R, Strauss FJ, Hammerle CHF, Jung RE. Two short implants versus one short implant with a cantilever: 5-Year results of a randomized clinical trial. J Clin Periodontol. 2021 Nov;48(11):1480-1490. doi: 10.1111/jcpe.13541. Epub 2021 Sep 22.

  PMID: 34448219 DERIVED

Study Officials

• Daniel Thoma, Prof. Dr.

  Clinic of Reconstructive Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: July 25, 2012
• Study Start: August 9, 2012
• Primary Completion: February 26, 2020
• Study Completion: February 28, 2025
• Last Updated: May 15, 2023

Record last verified: 2023-05

Locations

CH (1)