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OpenTrials
Completed

NCT Number: NCT02591706

Clinical Assessment of Dental Implant

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.

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Key information

Conditions

Tooth Loss Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Liège - Service de Médecine Dentaire

Liège, 4000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MIS Implants

Device

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.

Other names: MIS Implants Technologies

Primary outcomes

  1. Comparison of implant survival and success rate of V3 and C1 implants

    Time frame: 1 year

    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 outcomes

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

    Time frame: 1 year

    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.

Other outcomes

  1. Measurement of aesthetic outcomes based on the pink esthetic score

    Time frame: 1 year

    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).

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Collaborators

  • MIS Implant Technologies, Ltd

Registry information

Official study title

Clinical and Radiographic Assessment of V3 Implant: A Randomized Controlled Trial

Acronym: H2015-1

Important dates

Study start
2015
Primary completion
2016
Study completion
2019
First posted
Oct 29, 2015
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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