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A Clinical Evaluation of NobelProcera Implant Bar Overdenture

Primary Purpose

Edentulous

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

NobelReplace CC, NobelProcera Implant Bar

About this trial

This is an interventional treatment trial for Edentulous focused on measuring edentulous, maxilla, mandible, dental implant, bar, overdenture, Oral Health Impact Profile (OHIP), survival rate, technical complications, marginal bone level, soft tissue

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

The subject is at least 18 years of age (or age of consent) and has passed secession of growth
The subject is not older than 70 years
Obtained informed consent from the subject
Edentulous mandible or maxilla providing sufficient bone whereas removable NobelProceraTM Implant Bar Overdenture on four (4) implants is regarded as an appropriate treatment solution
The subject has an osseous architecture enough to receive four implants and a sufficient amount of bone for placing in healed or extraction sites implants with a length of at least 10mm
The implant site is free from infection and extraction remnants
Implants will be placed in healed or extractions sites, defined as a site with 8 weeks of healing following tooth extraction, respectively 6 months after major bone augmentation or soft tissue grafting
Good gingival / periodontal / periapical status of opposing teeth/implants
The subject fulfills the prerequisite that a harmonic, stable occlusal relationship can be achieved with opposing natural teeth resp. fixed or removable opposing dentition (tooth or implant based
The subjects as well as the implant site(s) fulfill the criteria for early loading (6 weeks until 3 months after implant placement)
The subject is in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems
The subject is available for the 5-year term of the investigation
The subject is compliant with good oral hygiene

Exclusion Criteria:

The subject is not able to give her/his informed consent of participating
Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure
Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or in subject history
Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area
Alcohol or drug abuse as noted in subject records or in subject history
Smoking of >10 cigarettes/day
Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake
Pathologic occlusion, e.g. severe bruxism or other destructive habits
Lack of opposing dentition or unstable occlusion
Ongoing infections, endodontic or periodontal problems in opposing teeth or implants
Subject shows an unacceptable oral hygiene
Subject has allergic or adverse reactions to the restorative material.
Bone augmentation of more than 3mm vertical height performed less than 3 months prior to planned implant placement.
Long-term bis-phosphonate therapy

Sites / Locations

Guido Heydecke
Nikolaus and Alexandra Behneke
Eugenio Romeo
Edoardo Stellini
Alessandro Pozzi
Università degli Studi di Sassari
Marco Ferrari

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Mandible

Maxilla

Arm Description

NobelReplace CC NobelProcera Implant Bar Titanium Overdenture (lab-made)

Outcomes

Primary Outcome Measures

MBL,marginal bone level change

To evaluate and compare the clinical marginal bone level change (change MBL)in relation to defined implant reference point and different time points in the maxilla and mandible(between baseline at implant insertion and follow-up time points at 1 month, 6 month, 1 year, 2 year, 3 year and 5 year after implant insertion) of observation.

Secondary Outcome Measures

CSR implants

CSR in % of placed implants

CSR prosthetics

survival in % of placed final restorations

Gingival Status

Gingival status(Silness and Loe 1963):0 = Normal gingiva surrounding crown/control tooth,1 = Mild inflammation,2 = Moderate inflammation.3 = Severe inflammation.

Status of mucosa

0 = No keratinized mucosa.1 = Mucosa partially keratinized.2 = entire mucosa keratinized.

Bleeding tendency

(modified Sulcus Bleeding Index_mBI)(Mombelli):0 = No bleeding when a periodontal probe is passed along gingival margin adjacent to the implant.1 = Isolated bleeding spots visible. 2 = Blood forms a confluent red line on the margin 3 = Heavy or profuse bleeding.

plaque accumulation

modified Plaque Index (mPlI) (Mombelli):0 = No detectible plaque. 1 = Plaque only recognized by running a probe across the marginal surface of the implant. 2 = Plaque can be seen by the naked eye.3 = Abundance of soft matter

Pocket depths

Pocket depths measured around implants in millimeter (mm)

Full Information

NCT ID

NCT01720420

First Posted

October 22, 2012

Last Updated

July 13, 2018

Sponsor

Nobel Biocare

Collaborators

Charite University, Berlin, Germany

1. Study Identification

Unique Protocol Identification Number

NCT01720420

Brief Title

A Clinical Evaluation of NobelProcera Implant Bar Overdenture

Official Title

A Clinical Evaluation of NobelProceraTM Implant Bar Overdenture in the Mandible or Maxilla on 4 NobelReplaceTM CC Implants

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 2012 (Actual)

Primary Completion Date

April 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nobel Biocare

Collaborators

Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

AN OPEN 5-YEAR PROSPECTIVE, CLINICAL MULTI-CENTER STUDY on NobelProcera Implant Bar Titanium with Locator attachment and related Overdenture on 4 NobelReplace implants with conical connection (CC) in the mandible/maxilla.

Detailed Description

Study centers: 8 centers in 4 countries Objectives of the study: Primary Objective: To evaluate and compare the clinical marginal bone level change (MBL) around the NobelReplaceTM CC implants supporting NobelProceraTM Implant Bar Overdenture (fixed-removable) in the mandible with the clinical marginal bone level change (MBL) of the NobelReplaceTM CC implants supporting NobelProceraTM Implant Bar Overdenture (fixed-removable) in the maxilla for a period of 5 years. Secondary Objectives: To evaluate and compare the cumulative survival rate (CSR) of the NobelReplaceTM CC implants supporting NobelProceraTM Implant Bar Overdenture (fixed-removable) in the mandible with the cumulative survival rate (CSR) of the NobelReplaceTM CC implants supporting NobelProceraTM Implant Bar Overdenture (fixed-removable) in the maxilla for a period of 5 years. To evaluate and compare the cumulative survival rate (CSR) of NobelProceraTM Implant Bar Overdenture (fixed-removable) on four (4) NobelReplace CC implants in the mandible with the cumulative survival rate (CSR) of NobelProceraTM Implant Bar Overdenture (fixed-removable) on four (4) NobelReplace CC implants in the maxilla after 5 years. To evaluate the clinical behaviour (soft tissue behavior, clinical function, patient satisfaction, Quality of Life and prosthetic maintenance needs such as wear, chipping of denture teeth, need for exchange of attachment components) of NobelProceraTM Implant Bar Overdenture (fixed-removable) in the mandible and maxilla over 5 years of clinical function. Study design 5-year, open, prospective, clinical multi-center study. Number of subjects 76 (in total), 7-9 per center Patient population Adult female or male, at least 18 (or age of consent) and not older than 70 years, suitable for treatment with implant supported bar overdentures in the edentulous mandible or maxilla.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Edentulous

Keywords

edentulous, maxilla, mandible, dental implant, bar, overdenture, Oral Health Impact Profile (OHIP), survival rate, technical complications, marginal bone level, soft tissue

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

77 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mandible

Arm Type

Experimental

Arm Description

NobelReplace CC NobelProcera Implant Bar Titanium Overdenture (lab-made)

Arm Title

Maxilla

Arm Type

Experimental

Arm Description

NobelReplace CC NobelProcera Implant Bar Titanium Overdenture (lab-made)

Intervention Type

Device

Intervention Name(s)

NobelReplace CC, NobelProcera Implant Bar

Other Intervention Name(s)

NobelReplace CC implants, NobelProcera Implant Bar Titanium, Overdenture (lab-made)

Intervention Description

Implants titanium with conical connection, individualized titanium bar

Primary Outcome Measure Information:

Title

MBL,marginal bone level change

Description

Time Frame

6 month, 1, 2, 3, 5 year

Secondary Outcome Measure Information:

Title

CSR implants

Description

CSR in % of placed implants

Time Frame

6 month, 1, 2, 3, 5 year

Title

CSR prosthetics

Description

survival in % of placed final restorations

Time Frame

6 month, 1, 2, 3, 5 year

Title

Gingival Status

Description

Gingival status(Silness and Loe 1963):0 = Normal gingiva surrounding crown/control tooth,1 = Mild inflammation,2 = Moderate inflammation.3 = Severe inflammation.

Time Frame

6 month, 1, 2, 3, 5 year

Title

Status of mucosa

Description

0 = No keratinized mucosa.1 = Mucosa partially keratinized.2 = entire mucosa keratinized.

Time Frame

6 month, 1, 2, 3, 5 year,

Title

Bleeding tendency

Description

Time Frame

6 month, 1, 2, 3, 5 year

Title

plaque accumulation

Description

Time Frame

6 month, 1, 2, 3, 5 year

Title

Pocket depths

Description

Pocket depths measured around implants in millimeter (mm)

Time Frame

6 month, 1, 2, 3, 5 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The subject is at least 18 years of age (or age of consent) and has passed secession of growth The subject is not older than 70 years Obtained informed consent from the subject Edentulous mandible or maxilla providing sufficient bone whereas removable NobelProceraTM Implant Bar Overdenture on four (4) implants is regarded as an appropriate treatment solution The subject has an osseous architecture enough to receive four implants and a sufficient amount of bone for placing in healed or extraction sites implants with a length of at least 10mm The implant site is free from infection and extraction remnants Implants will be placed in healed or extractions sites, defined as a site with 8 weeks of healing following tooth extraction, respectively 6 months after major bone augmentation or soft tissue grafting Good gingival / periodontal / periapical status of opposing teeth/implants The subject fulfills the prerequisite that a harmonic, stable occlusal relationship can be achieved with opposing natural teeth resp. fixed or removable opposing dentition (tooth or implant based The subjects as well as the implant site(s) fulfill the criteria for early loading (6 weeks until 3 months after implant placement) The subject is in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems The subject is available for the 5-year term of the investigation The subject is compliant with good oral hygiene Exclusion Criteria: The subject is not able to give her/his informed consent of participating Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or in subject history Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area Alcohol or drug abuse as noted in subject records or in subject history Smoking of >10 cigarettes/day Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake Pathologic occlusion, e.g. severe bruxism or other destructive habits Lack of opposing dentition or unstable occlusion Ongoing infections, endodontic or periodontal problems in opposing teeth or implants Subject shows an unacceptable oral hygiene Subject has allergic or adverse reactions to the restorative material. Bone augmentation of more than 3mm vertical height performed less than 3 months prior to planned implant placement. Long-term bis-phosphonate therapy

Overall Study Officials: