Clinical Assessment of Dental Implant

Tooth Loss Clinical Trial

— H2015-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02591706
• Other study ID #: H2015-1
• Status: Completed
• Phase: N/A
• Start date: February 2, 2015
• Est. completion date: June 2019

Study information

• Verified date: May 2022
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2019
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Tooth Loss

Intervention

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.

Locations

Country	Name	City	State
Belgium	CHU de Liège - Service de Médecine Dentaire	Liège

Sponsors (2)

Lead Sponsor	Collaborator
University of Liege	MIS Implant Technologies, Ltd

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measurement of aesthetic outcomes based on the pink esthetic score	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).	1 year
Primary	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.	1 year
Secondary	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.	1 year