Clinical trial NCT03100448: A 1-year Clinical Investigation on the On1 Concept
Official title: An Open, Prospective, Multi-center Study Evaluating the On1 Concept on NobelActive Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant
Lead sponsor: Nobel Biocare
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A 1-year Clinical Investigation on the On1 Concept.

Detailed description: This open, prospective, multi-center clinical trial evaluates the On1 Concept for the treatment of patients in need for single tooth replacement or 3-unit bridges in the mandible or maxilla.

Eligibility criteria: Inclusion Criteria:

* 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.

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.
* 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.

Primary outcomes:
measure: Marginal bone remodeling
timeFrame: 12 months
Secondary outcomes:
measure: Soft tissue outcome (soft tissue height)
timeFrame: 12 months
measure: Component Survival
timeFrame: 12 months
measure: Component Success
timeFrame: 12 months
measure: Patient's pain perception (visual analogue score)
timeFrame: 3 months
measure: Patient's oral health related quality of life (OHIP-14)
timeFrame: 12 months
measure: Patient's satisfaction with function & esthetics (visual analogue score)
timeFrame: 12 months
measure: Ease of use of the On1 Concept (questionnaire)
timeFrame: 12 months
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Service de Médecine dentaire CHU Sart Tilman
city: Cattolica
country: Italy
facility: Studio Odontoiatrico Specialistico
city: Kaunas
country: Lithuania
facility: Dental Clinic Auksteja
state: LT
city: Kaunas
country: Lithuania
facility: Dental Clinic Auksteja
city: Vilnius
country: Lithuania
facility: Vilnius Implantology Center
city: Hertogenbosch
country: Netherlands
facility: Tandartspraktijk Staas & Bergmans
Study officials:
affiliation: Nobel Bioacare
name: Alina Gologan, DMD
role: STUDY_DIRECTOR
References: