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EdentulousNCT01720420

A Clinical Evaluation of NobelProcera Implant Bar Overdenture

A study testing NobelReplace CC, NobelProcera Implant Bar in people with Edentulous, run by Nobel Biocare at 7 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Edentulous
What is being tested?
NobelReplace CC, NobelProcera Implant Bar
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
7 sitesin 2 countries
Study dates
Oct 2012to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

Italy5 sites

  • Eugenio Romeo

    Milan, 20143

  • Edoardo Stellini

    Padova, 35128

  • Alessandro Pozzi

    Rome, 00133

  • Università degli Studi di Sassari

    Sassari

  • Marco Ferrari

    Siena, 53100

Other trials in Italy

Germany2 sites

  • Guido Heydecke

    Hamburg, 20246

  • Nikolaus and Alexandra Behneke

    Mainz, 55131

Other trials in Germany

About this study

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

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.

Read the 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:

  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.

Conditions
Edentulous
Being tested
NobelReplace CC, NobelProcera Implant Bar
Keywords
edentulous, maxilla, mandible, dental implant, bar, overdenture, Oral Health Impact Profile (OHIP), survival rate, technical complications, marginal bone level, soft tissue
Medical subject headings
Mouth, Edentulous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NobelReplace CC, NobelProcera Implant BarDevice

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

    Implants titanium with conical connection, individualized titanium bar

Study groups in NCT01720420
Study groupRoleWhat they receive
MandibleExperimentalNobelReplace CC NobelProcera Implant Bar Titanium Overdenture (lab-made)
Receives: Device: NobelReplace CC, NobelProcera Implant Bar
MaxillaExperimentalNobelReplace CC NobelProcera Implant Bar Titanium Overdenture (lab-made)
Receives: Device: NobelReplace CC, NobelProcera Implant Bar

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (7)

  1. CSR implants

    CSR in % of placed implants

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

  2. CSR prosthetics

    survival in % of placed final restorations

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

  3. Gingival Status

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

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

  4. Status of mucosa

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

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

  5. 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.

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

  6. 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

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

  7. Pocket depths

    Pocket depths measured around implants in millimeter (mm)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionApr 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01720420
Sponsor's protocol ID
T-174
Status last verified
Jul 2018
First submitted
22 Oct 2012
Last updated
16 Jul 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing NobelReplace CC, NobelProcera Implant Bar in people with Edentulous, run by Nobel Biocare at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Italy, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MBL,marginal bone level change (time frame: 6 month, 1, 2, 3, 5 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01720420.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2018.

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