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Clinical Assessment of Dental Implant (H2015-1)

Primary Purpose

Tooth Loss

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
MIS Implants
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Loss focused on measuring Single missing tooth, Implants, Peri-implant bone remodeling, Bone thickness, Thickness of soft tissue

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject must have voluntarily signed the informed consent form before any study related action
  • Age: 18 with one or more missing teeth in the maxillary area, seeking for implant therapy.
  • Men/Women
  • In good systemic health (ASA I/ II)
  • Present with no contra indication against oral surgical interventions
  • Patients required replacement of a single missing tooth. The tooth at the implant site(s) must have been extracted or lost at least 12 weeks before the date of implantation.
  • At least 10 mm of bone in the vertical dimension
  • At least 6 mm of bone in the bucco-lingual dimension.
  • No need for bone augmentation procedure in any of the dimensions
  • Full mouth plaque score (FMPI) lower or equal than 25%

Exclusion Criteria:

  • Autoimmune disease require medical treatment
  • Medical conditions requiring prolonged use of steroids
  • Use of Bisphosphonate intravenously or more then
  • Infection (local or systemic) - patient with gingivitis or active local infection will undergo a medical treatment prior to his entrance to the study, each individual will be evaluated prior to study procedure for suitability, in case of systemic infection the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
  • Current pregnancy or breastfeeding women
  • Alcoholism or chronically drug abuse
  • Immunocompromised patients
  • Uncontrolled Diabetes
  • Smokers
  • Prisoners

Sites / Locations

  • CHU de Liège - Service de Médecine Dentaire

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Dental implant (C1)

Dental implant (V3)

Arm Description

Internal Conical Connection: The C1 has a six-position cone index, except for the C1 narrow platform that has a four-position cone index. The conical connection is 2.00mm in depth, with a 12° cone. As a result of our meticulous manufacturing process a perfect fit between the implant and the abutment is achieved, eliminating micro-movements and minimizing bone resorption. Patient will be randomly assigned to one of the two groups after flap opening.

The unique triangular shape of the coronal portion of the V3 implant results in less titanium and more bone and soft tissue visible in the esthetic zone, for a restorative-driven approach and easier soft tissue management. The V3 provides doctors with a more advantageous starting point; where greater volume of bone and soft tissue is achieved at the onset of implant placement. Patient will be randomly assigned to one of the two groups after flap opening.

Outcomes

Primary Outcome Measures

Comparison of implant survival and success rate of V3 and C1 implants
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 similar and that test V3 implant allows less peri-implant bone loss.

Secondary Outcome Measures

Comparison of the thickness of hard tissue in the buccal aspect of the V3 and C1 implants
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.

Full Information

First Posted
October 9, 2015
Last Updated
May 18, 2022
Sponsor
University of Liege
Collaborators
MIS Implant Technologies, Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02591706
Brief Title
Clinical Assessment of Dental Implant
Acronym
H2015-1
Official Title
Clinical and Radiographic Assessment of V3 Implant: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 2, 2015 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
Collaborators
MIS Implant Technologies, Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Loss
Keywords
Single missing tooth, Implants, Peri-implant bone remodeling, Bone thickness, Thickness of soft tissue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dental implant (C1)
Arm Type
Active Comparator
Arm Description
Internal Conical Connection: The C1 has a six-position cone index, except for the C1 narrow platform that has a four-position cone index. The conical connection is 2.00mm in depth, with a 12° cone. As a result of our meticulous manufacturing process a perfect fit between the implant and the abutment is achieved, eliminating micro-movements and minimizing bone resorption. Patient will be randomly assigned to one of the two groups after flap opening.
Arm Title
Dental implant (V3)
Arm Type
Experimental
Arm Description
The unique triangular shape of the coronal portion of the V3 implant results in less titanium and more bone and soft tissue visible in the esthetic zone, for a restorative-driven approach and easier soft tissue management. The V3 provides doctors with a more advantageous starting point; where greater volume of bone and soft tissue is achieved at the onset of implant placement. Patient will be randomly assigned to one of the two groups after flap opening.
Intervention Type
Device
Intervention Name(s)
MIS Implants
Other Intervention Name(s)
MIS Implants Technologies
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of implant survival and success rate of V3 and C1 implants
Description
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 similar and that test V3 implant allows less peri-implant bone loss.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Comparison of the thickness of hard tissue in the buccal aspect of the V3 and C1 implants
Description
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.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Measurement of aesthetic outcomes based on the pink esthetic score
Description
The mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue color and texture will be assessed at baseline (crown placement) and at 1 year after the final restoration by using the Pink Esthetics Score (PES).
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject must have voluntarily signed the informed consent form before any study related action Age: 18 with one or more missing teeth in the maxillary area, seeking for implant therapy. Men/Women In good systemic health (ASA I/ II) Present with no contra indication against oral surgical interventions Patients required replacement of a single missing tooth. The tooth at the implant site(s) must have been extracted or lost at least 12 weeks before the date of implantation. At least 10 mm of bone in the vertical dimension At least 6 mm of bone in the bucco-lingual dimension. No need for bone augmentation procedure in any of the dimensions Full mouth plaque score (FMPI) lower or equal than 25% Exclusion Criteria: Autoimmune disease require medical treatment Medical conditions requiring prolonged use of steroids Use of Bisphosphonate intravenously or more then Infection (local or systemic) - patient with gingivitis or active local infection will undergo a medical treatment prior to his entrance to the study, each individual will be evaluated prior to study procedure for suitability, in case of systemic infection the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests. Current pregnancy or breastfeeding women Alcoholism or chronically drug abuse Immunocompromised patients Uncontrolled Diabetes Smokers Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
France LAMBERT
Organizational Affiliation
University of Liege
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Liège - Service de Médecine Dentaire
City
Liège
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

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Clinical Assessment of Dental Implant

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