Evaluation of Efficacy and Safety of Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation

Wishbone SA

Status

Unknown

Conditions

Bone Loss in Jaw

Treatments

Device: Bone graft substitute

Study type

Interventional

Funder types

Industry

Identifiers

20181207_WHA_CIP

Details and patient eligibility

About

Evaluation of efficacy and safety of Wishbone HA as bone graft substitute, a pre-market clinical investigation.

Group1: Extraction Socket management Group 2: Sinus lift

Enrollment

47 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subject signed the informed consent form
Subject is ≥18 and ≤ 80 years old.
Subject presented in need of:
1. tooth extraction without estimated need of connective tissue grafting OR
2. defect in the upper jaw requiring sinus lift with or without lateral augmentation procedure prior to implant placement
The subject is willing and able to comply with all investigation related procedures (such as exercising oral hygiene and attending all follow-up visits).
Full-mouth bleeding score (FMBS) lower than 25%
Full-mouth plaque score (FMPI) lower than 25%
The subject displays no clinical contraindications for a 2-stage surgical procedure

Exclusion criteria

Less than 2 mm of remaining keratinized mucosa
Severe vertical resorption of the crest (except internal resorptions, i.e. expanded sinuses)
Ridge with prior bone augmentation procedure performed (i.e ridge preservation)
Any disorders in the planned implant area such as previous tumors, chronic bone disease.
Alcohol or drug abuse as noted in subject records or in subject history.
Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc).
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 history.
Smoking: >10 cigarettes per day