A Clinical Evaluation of NobelProcera Implant Bar Overdenture

Edentulous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01720420
• Other study ID #: T-174
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2012
• Est. completion date: December 2020

Study information

• Verified date: July 2018
• Source: Nobel Biocare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 77
• Est. completion date: December 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. The subject is at least 18 years of age (or age of consent) and has passed secession of growth

2. The subject is not older than 70 years

3. Obtained informed consent from the subject

4. Edentulous mandible or maxilla providing sufficient bone whereas removable NobelProceraTM Implant Bar Overdenture on four (4) implants is regarded as an appropriate treatment solution

5. 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

6. The implant site is free from infection and extraction remnants

7. 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

8. Good gingival / periodontal / periapical status of opposing teeth/implants

9. 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

10. The subjects as well as the implant site(s) fulfill the criteria for early loading (6 weeks until 3 months after implant placement)

11. The subject is in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems

12. The subject is available for the 5-year term of the investigation

13. The subject is compliant with good oral hygiene

Exclusion Criteria:

1. The subject is not able to give her/his informed consent of participating

2. Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure

3. 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

4. Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area

5. Alcohol or drug abuse as noted in subject records or in subject history

6. Smoking of >10 cigarettes/day

7. Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake

8. Pathologic occlusion, e.g. severe bruxism or other destructive habits

9. Lack of opposing dentition or unstable occlusion

10. Ongoing infections, endodontic or periodontal problems in opposing teeth or implants

11. Subject shows an unacceptable oral hygiene

12. Subject has allergic or adverse reactions to the restorative material.

13. Bone augmentation of more than 3mm vertical height performed less than 3 months prior to planned implant placement.

14. Long-term bis-phosphonate therapy

Related Conditions & MeSH terms

• Edentulous
• Mouth, Edentulous

Intervention

Device:
• NobelReplace CC, NobelProcera Implant Bar
Implants titanium with conical connection, individualized titanium bar

Locations

Country	Name	City	State
Germany	Guido Heydecke	Hamburg
Germany	Nikolaus and Alexandra Behneke	Mainz
Italy	Eugenio Romeo	Milan
Italy	Edoardo Stellini	Padova
Italy	Alessandro Pozzi	Rome
Italy	Università degli Studi di Sassari	Sassari
Italy	Marco Ferrari	Siena

Sponsors (2)

Lead Sponsor	Collaborator
Nobel Biocare	Charite University, Berlin, Germany

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 month, 1, 2, 3, 5 year
Secondary	CSR implants	CSR in % of placed implants	6 month, 1, 2, 3, 5 year
Secondary	CSR prosthetics	survival in % of placed final restorations	6 month, 1, 2, 3, 5 year
Secondary	Gingival Status	Gingival status(Silness and Loe 1963):0 = Normal gingiva surrounding crown/control tooth,1 = Mild inflammation,2 = Moderate inflammation.3 = Severe inflammation.	6 month, 1, 2, 3, 5 year
Secondary	Status of mucosa	0 = No keratinized mucosa.1 = Mucosa partially keratinized.2 = entire mucosa keratinized.	6 month, 1, 2, 3, 5 year,
Secondary	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.	6 month, 1, 2, 3, 5 year
Secondary	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	6 month, 1, 2, 3, 5 year
Secondary	Pocket depths	Pocket depths measured around implants in millimeter (mm)	6 month, 1, 2, 3, 5 year