NCT03471000

Brief Summary

The aim of the study was to determine whether implant length and the crown-to-implant (C/I) ratio influence implant stability and the loss of the surrounding marginal bone, and whether short implants can be used instead of sinus augmentation procedures.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

4 years

First QC Date

March 5, 2018

Last Update Submit

January 11, 2020

Conditions

Partial EdentulismTooth Loss

Keywords

implantdental implant

Outcome Measures

Primary Outcomes (1)

  • Clinical measurement of implant stability

    Evaluation of implant secondary stability in both groups. Stability measured and evaluated with Periotest(R) device - after 36 months.

    36 months

Secondary Outcomes (1)

  • Radiological measurement of marginal bone loss around implant

    36 months

Study Arms (2)

Short implants Treatment

EXPERIMENTAL

Group 2 (G2; n=15 patients) had short implants (OsseoSpeed ™ L6mm Ø4 mm) \[DENTSPLY Implants, Waltham, MA, USA\] placed without sinus lift and augmentation procedure.

Other: Short implants Treatment

Regular Implants Treatment

ACTIVE COMPARATOR

Group 1 (G1; n=15 patients) had conventional dental implants (OsseoSpeed ™ L11 Ø4 mm and L13 Ø4 mm) \[DENTSPLY Implants, Waltham, MA, USA\] placed, preceded by the sinus lift procedure from a lateral window approach with the application of the xenogeneic bone graft Geistlich Bio-Oss® \[Geistlich AG, Wolhusen, Switzerland\]. The lateral window approach sinus lift surgery was performed 6 weeks prior to the implant placement by the same surgeon.

Other: Regular implants Treatment

Interventions

Short implants TreatmentOTHER

Short implants are placed in the alveolar bone and a clinical Ostell and Periotest evaluation of the implants after a period of time is done. Analysis of periapical radiographs and CBCT images after a period of time. Bone around the implant was measured, marginal bone level loss is determined.

Short implants Treatment
Regular implants TreatmentOTHER

Sinus lift procedure is done and regular implants are placed in the alveolar bone and a clinical Ostell and Periotest evaluation of the implants after a period of time is done. Analysis of periapical radiographs and CBCT images after a period of time. Bone around the implant was measured, marginal bone level loss is determined.

Regular Implants Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-smoking patients with no systemic or local diseases were qualified.
  • minimal apicocoronal height of the alveolar ridge of 6 mm in the region of the implant insertion in the pre-surgical qualification
  • minimal width of the alveolar ridge of 6-7 mm in the region of interest
  • HKT (height of the keratinized tissue) higher than 2 mm
  • API ≤ 35 (Approximal Plaque Index)
  • PI ≤ 25. (Plaque Index)
  • Bone Type III or D2 were included in the study
  • No graft procedures in the area of interest,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hadzik J, Krawiec M, Slawecki K, Kunert-Keil C, Dominiak M, Gedrange T. The Influence of the Crown-Implant Ratio on the Crestal Bone Level and Implant Secondary Stability: 36-Month Clinical Study. Biomed Res Int. 2018 May 16;2018:4246874. doi: 10.1155/2018/4246874. eCollection 2018.

    PMID: 29862269RESULT

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Marzena Dominiak, Prof

    Medical University Wrocław

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD, DDS

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 20, 2018

Study Start

January 1, 2012

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 14, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share