Short Implants in Edentulous Mandible

April 7, 2021 updated by: Universitätsklinikum Hamburg-Eppendorf

Prospective Clinical Study of Straumann Roxolid®/SLactive® Short Implants in Edentulous Mandible

Main aim of this study was to assess survival rates of short implants with a length of 4 mm in the edentulous mandible after 1, 3, and 5 years.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

It is hypothesized that survival rates after 1, 3, and 5 years of Straumann Roxolid® / SLActive® 4 mm short implants do not differ from values of Straumann SLActive implants with more than 4 mm length in the same clinical situation.

Study Type

Observational

Enrollment (Actual)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Dental patients of university-based prosthodontic department (primary, secondary, and tertiary care clinic)

Description

Inclusion Criteria:

General criteria:

  • Age: 18 to 70
  • Edentulous mandible with reduced bone level in the posterior region (> 5 mm and < 8 mm above nerve conduit)
  • Physical and mental condition that allow surgery and a 5-year follow-up period to be carried out without foreseeable problems
  • Obtained informed consent from the patient

Specific criteria:

  • Limited vertical space for implant placement, where conventional implants with lengths of more than 4 mm cannot be used
  • Tooth loss or extraction at least 8 weeks before implant surgery
  • Healthy implantation site
  • Favorable and stable occlusal relationship
  • Complete denture in the mandible. If no denture available, an interims prosthesis will be fitted
  • Natural full dentition or sufficient complete or partial dentures in the maxilla

Exclusion Criteria:

General criteria:

  • Any conditions or circumstances which would interfere with the requirements for oral surgery
  • Allergy to any metallic implant component
  • Acute, untreated periodontitis
  • Previous oro-maxillo-facial radiotherapy
  • Any disorders in the planned implant area such as previous tumors or chronic bone disease (e.g., rheumatoid disease)
  • Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc.)
  • Alcohol or drug abuse
  • Heavy smoking (>10 cigarettes/day)
  • Uncontrolled diabetes
  • Severe bruxism or other destructive oral habits
  • Pregnant or lactating women

Specific criteria:

  • Need for a major bone regeneration technique
  • Infections in adjacent tissue of the planned implantation site.
  • Bleeding on probing (BOP) and plaque index (PI) higher 25%
  • Insufficient bone volume in the posterior region for placing a Straumann Roxolid® / SLActive® 4mm short implant and in the interforaminal region for placing a Straumann Roxolid® / SLActive® implant with a minimum length of 10 mm determined by radiographic analysis (OPG)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dental patients
Patients with an edentulous mandible who are demanding and receiving an implant-supported fixed dental prosthesis in the mandible
Device: Dental Implants (Straumann Roxolid® / SLActive®)

In this study the 4 mm implants will be inserted in the area surrounding 36/46. The implant diameters will be defined based on the patient's situation.

In the interforaminal region, two implants of conventional length with a minimum of 10 mm will be inserted. The implant diameter and the length will be defined based on the patient's situation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 5 years
Survival of implants and suprastructure. Measure: survival rates
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant stability
Time Frame: 3 months

Within-subject comparison of primary (at implant placement) and secondary (at implant exposure) stability of short versus regular length implants.

Measure / device: Resonance Frequency Analysis (RFA)
3 months
Success
Time Frame: 5 years

Success of implants and suprastructure. Measure: success rates

  • Biological success:

    • No detectable clinical mobility (hand testing)
    • No radiolucency surrounding the total surface of the implant
    • No persistent pain refractory to medical therapy

    • No recurrent peri-implant infection

      • Peri-implant infection: peri-implant Probing Depth (PD), Plaque Index (Pl), and Bleeding on Probing (BoP)
      • Bone loss: standardized intra-oral radiography with long-cone parallel technique

  • Technical success:

    • No screw loosening
    • No fracture of metal base
    • No fracture of veneering material
5 years
Oral health-related quality of life
Time Frame: 5 years

Oral health-related quality of life (OHRQoL). Measure: questionnaire

- 49-item Oral Health Impact Profile (OHIP) with a 5-point ordinal rating scale (possible range of summary scores: 0-196 with higher scores indicating more impairment)
5 years
Patient satisfaction
Time Frame: 5 years

Patient satisfaction. Measure: questionnaire

- Visual analogue scales (VAS) on ease of cleaning, speech, comfort, esthetic, stability, chewing ability, masticatory function, and oral health (possible range of scores: 0-10 for each item with higher scores indicating more satisfaction)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

Straumann AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2015

Primary Completion (Anticipated)

March 31, 2024

Study Completion (Anticipated)

March 31, 2024

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 9, 2021

Study Record Updates

Last Update Posted (Actual)

April 9, 2021

Last Update Submitted That Met QC Criteria

April 7, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PV_4805

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tooth Loss

Clinical Trials on Dental Implants (Straumann Roxolid® / SLActive®)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe