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

NCT ID: NCT04054219

Last Updated: 2019-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-08
• Study Completion Date: 2021-05-31

Brief Summary

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

Conditions

Bone Loss in Jaw

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Bone graft substitute

Evaluation of a device made of deproteinized bovine bone material as bone graft substitute in different indications requiring bone grafting procedures before implant placement

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wishbone SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Liège

Liège, , Belgium

Site Status: RECRUITING

Countries

Belgium

Facility Contacts

France Lambert

Role: primary

France.Lambert@chuliege.be

003243667654

Other Identifiers

20181207_WHA_CIP

Identifier Type: -

Identifier Source: org_study_id