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Clinical Assessment of Dental Implant

NCT02591706 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-05-19

No results posted yet for this study

Summary

Primary Endpoints : The implant survival and success rate of V3 and C1 implants will be compared. Implant success rate will be evaluated by measuring the peri-implant bone remodeling from baseline to 1 year post insertion.

The hypothesis is those implant survival rates of the test (V3) and control group (C1) are similar and that test V3 implant allows less peri-implant bone loss.

Secondary Endpoints : The thickness of hard tissue in the buccal aspect of the V3 and C1 implants will be compared. The bone thickness will be measured in cone beam computerized tomography (CBCT) on the day of implantation, 4 and at one year after the final restoration.

The hypothesis is that V3 implant allows thicker bone dimension in the cervical area.

Conditions

  • Tooth Loss

Interventions

DEVICE

MIS Implants

The implantation procedure will be carried out according to a standard surgical protocol, and according the manufacture protocol. Patient will be randomly assigned to one of the two groups after flap opening. The implant stability will be measured using the wench key and recorded in N/cm. The implants will be covered with healing abutments for trans-gingival healing for a period of 4 months. The area will be sutured with thin nylon sutures for a primary passive fit closure. Immediately after the surgery the patient will perform a CBCT of the treated area with a cotton roll on the buccal side in order to be able to evaluate the buccal soft tissue thickness.

Sponsors & Collaborators

  • MIS Implant Technologies, Ltd

    collaborator INDUSTRY

  • University of Liege

    lead OTHER

Principal Investigators

  • France LAMBERT · University of Liege

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-02
Primary Completion
2016-03-31
Completion
2019-06-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02591706 on ClinicalTrials.gov