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

NCT04054219 | Unknown

• 1 other identifier: 20181207_WHA_CIP
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Measure of the bone augmentation success

  Group 1 - Extraction Socket Management: Efficacy endpoint based on the bone augmentation success (bone gain after bone augmentation procedure) measured by Cone Beam CT

  4 months after procedure

• Measure of the bone augmentation success

  Group 2 - Sinus lift: Efficacy endpoint based on the bone augmentation success (bone gain after bone augmentation procedure) measured by Cone Beam CT

  6 months after procedure

Secondary Outcomes (15)

• Safety endpoint: Collection of all device related adverse events

  4 months after procedure

• Safety endpoint: Collection of all device related adverse events

  6 months after procedure

• Procedure success: ability to successfully perform the implants placement

  4 months after procedure

• Procedure success: ability to successfully perform the implants placement

  6 months after procedure

• Site preparation: need for under or over preparation of the osteotomy

  4 months after procedure

Interventions

Bone graft substitute DEVICE

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wishbone SA: lead

Study Sites (1)

CHU de Liège

Liège, 4000, Belgium

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 13, 2019
• Study Start: July 8, 2019
• Primary Completion: February 28, 2020
• Study Completion: May 31, 2021
• Last Updated: August 21, 2019

Record last verified: 2019-08

Locations

BE (1)