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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02175550
Other study ID # T-179
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2011
Est. completion date December 2018

Study information

Verified date March 2021
Source Nobel Biocare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A new Nobel Biocare implant, NobelReplace Conical Connection (NR CC) has been developed. The implant is a two piece design to allow both one- and two- stage surgical procedures. The entire implant surface has a porous titanium oxide of approximately 10µm thick (TiUnite) to promote and maintain primary stability, which later on leads to secondary stability. NR CC implants are used as the foundation for anchoring tooth replacements in either jaw. Restorations range from replacing one single tooth to an entire arch of bridgework. The implants are also intended as retentive elements for overdenture applications. The present study is designed to evaluate, after the insertion of the NR CC, the marginal bone levels and bone remodelling at the implant sites over various time points up to 5 years. Parameters as soft tissue index, pink aesthetic score (PES) and bleeding on probing (BoP) are as well evaluated together with implant success and survival rate. Using the OHIP-14 questionnaire patients satisfaction is assessed. The results of this clinical investigation will demonstrate clinical safety and reliability of the NR CC using different treatment options.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date December 2018
Est. primary completion date July 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Obtained informed consent from the subject. - The subject shall be at least 18 years of age and have passed secession of growth - The subject must be in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems. (The patient is committed to the study - The subject requires single unit implant restoration in the anterior maxilla (FDI 15-25); (ADA 4-13) - The tooth at the planned study site of interest is extracted or lost at least 2 months before the date of implantation - Healthy implantation site - Full mouth bleeding on probing (FMBoP) and full mouth plaque index (FMPI) are both lower or equal to 25% - The subject shall have a favorable and stable occlusal relationship - Natural roots are adjacent to the implant site - Maximum two single unit restorations per patient - The patient is suitable for a 1-stage surgical procedure - The patient is suitable for immediate temporization without full occlusal loading - Subject's acceptance of the scheduled program of clinical and radiographic analysis and maintenance. Exclusion Criteria: - Insufficient bone volume at the implant site for placing a NobelReplace CC NP 3.5 implant with a length of at least 8 mm. - Major bone augmentation procedure at the site of implantation - Primary stability of the placed implant is =35Ncm - Implant insertion of = 45Ncm - Acute, untreated periodontitis - Health conditions, which do not permit the surgical treatment - Any disorders in the planned implant area such as previous tumors, chronic one disease (such as rheumatoid disease) - Infections in adjacent tissue of the planned implantation site - Previous oro-maxillo-facial radiotherapy - Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc) - Alcohol or drug abuse as noted in subject records or in subject history - Heavy smoking (>10 cigarettes/day) - Uncontrolled diabetes - Severe bruxism or other destructive habits - Pregnant or lactating woman

Study Design


Related Conditions & MeSH terms


Intervention

Device:
NR CC


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Nobel Biocare

Outcome

Type Measure Description Time frame Safety issue
Primary Bone levels and bone remodeling at the implant sites The parameter will be measured at 1, 2, 3 and 5 years after implant insertion yearly, from baseline up to 5 years
Secondary Soft Tissue Index The parameter will be measured at 1, 2, 3 and 5 years after implant insertion yearly, from baseline up to 5 years
Secondary Pink Aesthetic Score (PES) The parameter will be measured at 1, 2, 3 and 5 years after implant insertion yearly, from baseline up to 5 years
Secondary Bleeding on Probing (BoP) The parameter will be measured at 1, 2, 3 and 5 years after implant insertion yearly, from baseline up to 5 years
Secondary Patient satisfaction Patient satisfaction will be assessed at 1, 2, 3 and 5 years after implant insertion yearly, from baseline up to 5 years
Secondary success and survival rates of implants. Success and survival rate will be assessed at 1, 2, 3 and 5 years after implant insertion yearly, from baseline up to 5 years
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