1-year clinical investigation on the On1 Concept - On1 clinical investigation

obel Biocare services AG0 个研究点目标入组 17 人开始时间: 待定最近更新: 2024年2月28日

试验速览

暂无简介。

•The subject is at least 18 years of age (or age of consent) and has passed cessation of
•* 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
•* 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.

•* 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
•* 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
•* 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

发起方

obel Biocare services AG