Status:
UNKNOWN
Evaluation of Efficacy and Safety of Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation
Lead Sponsor:
Wishbone SA
Conditions:
Bone Loss in Jaw
Eligibility:
All Genders
18-80 years
Phase:
NA
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
Eligibility Criteria
Inclusion
- Subject signed the informed consent form
- Subject is ≥18 and ≤ 80 years old.
- Subject presented in need of:
- tooth extraction without estimated need of connective tissue grafting OR
- 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
- 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
Key Trial Info
Start Date :
July 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2021
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04054219
Start Date
July 8 2019
End Date
May 31 2021
Last Update
August 21 2019
Active Locations (1)
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1
CHU de Liège
Liège, Belgium, 4000