A 1-year Clinical Investigation on the On1 Concept

NCT03100448 | Completed

• 1 other identifier: T-190
• Study Type: interventional
• Target: 72
• Locations: 4 countries
• Sites: 6

Brief Summary

A 1-year Clinical Investigation on the On1 Concept.

Conditions

Implant

Outcome Measures

Primary Outcomes (1)

• Marginal bone remodeling

  The change in the marginal bone level around the implants from baseline to 12-months of follow-up is measured on paired radiographs.

  12 months

Secondary Outcomes (7)

• Soft tissue outcome (soft tissue height)

  12 months

• Component Survival

  12 months

• Component Success

  12 months

• Patient's pain perception (visual analogue score)

  3 months

• Patient's oral health related quality of life (OHIP-14)

  12 months

Study Arms (1)

On1 Concept

OTHER

On1 Concept \& NobelActive implants

Device: On1 Concept

Interventions

On1 Concept DEVICE

NobelActive implant placement with simultaneous On1 Base placement

On1 Concept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is at least 18 years of age (or age of consent) and has passed cessation of growth.
• Obtained informed consent from the subject.
• The patient is willing and able to comply with all study related procedures (such as exercising oral hygiene and attending all follow-up procedures).
• The subject shall be healthy and compliant with good oral hygiene.
• Full-mouth bleeding score (FMBS) lower than 25% \[10\].
• Full-mouth plaque score (FMPI) lower than 20% \[11\].
• Suitable for implant treatment in the posterior, pre-molar and canine area in the mandible or maxilla.
• The subject shall have a favorable and stable occlusal relationship.
• In need of one or multiple single tooth replacements or 3-unit bridges.
• Healed sites in need for implant placement (i.e. minimum of 6 weeks post extraction).
• The implant sites are free from infection and extraction remnants.
• The subject is suitable for a 1-stage surgical procedure.
• Sufficient amount of buccal and lingual keratinized mucosa.
• The subject has a sufficient amount of bone for placing NobelActive implants with a length of at least 8 mm.
• Primary implant stability as assessed by manual hand testing.

You may not qualify if:

• 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.
• Infections in the planned implantation site or adjacent tissue.
• Acute, untreated periodontitis in the planned implantation site or adjacent tissue.
• Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc.).
• Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake or A1c level above 8%.
• Alcohol or drug abuse as noted in subject records or in subject history.
• Smoking of \>10 cigarettes/day.
• Fresh extraction sites (up to 6 weeks).
• Severe bruxism or other destructive habits.
• Pregnant or lactating women at the time of implant insertion.
• Previous bone augmentation (lateral and/or vertical).
• Soft tissue augmentation less than 2 months before implant placement.

Sponsors & Collaborators

• Nobel Biocare: lead

Study Sites (6)

Service de Médecine dentaire CHU Sart Tilman

Liège, 4000, Belgium

Location

Studio Odontoiatrico Specialistico

Cattolica, 47841, Italy

Location

Dental Clinic Auksteja

Kaunas, LT, 44275, Lithuania

Location

Dental Clinic Auksteja

Kaunas, 44275, Lithuania

Location

Vilnius Implantology Center

Vilnius, 01205, Lithuania

Location

Tandartspraktijk Staas & Bergmans

's-Hertogenbosch, 5216, Netherlands

Location

Study Officials

• Alina Gologan, DMD

  Nobel Bioacare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: April 4, 2017
• Study Start: February 24, 2017
• Primary Completion: May 8, 2019
• Study Completion: May 8, 2019
• Last Updated: February 1, 2021

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); NL (1); BE (1); LI (3)