Clinical trial NCT04054219: Evaluation of Efficacy and Safety of Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation
Official title: Prospective, Single Center, Pivotal Investigation to Investigate Efficacy and Safety of WISHBONE HA, Used as Bone Graft Substitute for Different Indications Where Bone Grafting Procedures Are Required Before Implant Placement.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Loss in Jaw
Lead sponsor: Wishbone SA
Sponsor class: INDUSTRY
First posted: 2019-08-13
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Measure of the bone augmentation success
timeFrame: 4 months after procedure
measure: Measure of the bone augmentation success
timeFrame: 6 months after procedure
Secondary outcomes:
measure: Safety endpoint: Collection of all device related adverse events
timeFrame: 4 months after procedure
measure: Safety endpoint: Collection of all device related adverse events
timeFrame: 6 months after procedure
measure: Procedure success: ability to successfully perform the implants placement
timeFrame: 4 months after procedure
measure: Procedure success: ability to successfully perform the implants placement
timeFrame: 6 months after procedure
measure: Site preparation: need for under or over preparation of the osteotomy
timeFrame: 4 months after procedure
measure: Site preparation: need for under or over preparation of the osteotomy
timeFrame: 6 months after procedure
measure: Assessment of the bone quality and bone quantity
timeFrame: 4 months after procedure
measure: Assessment of the bone quality and bone quantity
timeFrame: 6 months after procedure
measure: Implant survival
timeFrame: 1 year after after definitive prosthesis delivery
measure: Implant success
timeFrame: 1 year after after definitive prosthesis delivery
measure: Papilla index evaluation
timeFrame: 1 year after definitive prosthesis delivery
measure: Plaque index evaluation
timeFrame: 1 year after definitive prosthesis delivery
measure: Bleeding index evaluation
timeFrame: 1 year after definitive prosthesis delivery
measure: Keratinized mucosa evaluation
timeFrame: 1 year after definitive prosthesis delivery
measure: Patient Oral health profile evaluation
timeFrame: 1 year follow-up visit
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU de Liège
Study officials:
References: