NCT04838184

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Status
unknown

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

Study Start

First participant enrolled

April 19, 2015

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

April 9, 2021

Status Verified

March 1, 2021

Enrollment Period

9 years

First QC Date

March 18, 2021

Last Update Submit

April 7, 2021

Conditions

Tooth LossEdentulous Jaw

Outcome Measures

Primary Outcomes (1)

  • Survival

    Survival of implants and suprastructure. Measure: survival rates

    5 years

Secondary Outcomes (4)

  • Implant stability

    3 months

  • Success

    5 years

  • Oral health-related quality of life

    5 years

  • Patient satisfaction

    5 years

Study Arms (1)

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®)

Interventions

Dental Implants (Straumann Roxolid® / SLActive®)DEVICE

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.

Dental patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth LossJaw, Edentulous

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth DiseasesJaw DiseasesMusculoskeletal DiseasesMouth, Edentulous

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2021

First Posted

April 9, 2021

Study Start

April 19, 2015

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

April 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share