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

May 28, 2024 updated by: Wishbone SA

Prospective, Multi-center, Randomized, Single Blinded and Parallel Controlled Clinical Investigation to Assess the Performance, Safety and Benefit of the Wishbone HA Medical Device, a Deproteinized Bovine Bone Material, as a Bone Graft Substitute in the Socket Management Indication Requiring Bone Grafting Procedure Before Implant Placement.

This investigation is a pre-market, prospective, multi-center, randomized, single blinded, parallel controlled clinical investigation performed in at least 5 clinical centers for confirmatory purposes of the use of WHA as intended in the filling of extraction sockets to enhance preservation of the alveolar socket.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, the subjects will be pseudonymized and randomized in a 1:1 ratio between WHA and the selected comparator device Bio-Oss®. The sample size of the study has been computed based on a non-inferiority test between Bio- Oss® and WHA for device performance for the filling of extraction sockets. A total of 96 subjects will be enrolled.

The results will be used to demonstrate the safety, performance and benefit of the product WHA in the socket indication in compliance with the MDR 2017/745.

The endpoints are all accurately based on objective measurements:

  • Primary Endpoint: Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure.

  • Secondary Endpoints:

    • Evaluation of implant stability at placement.
    • Assessment of bone density at the time of implant insertion.
    • Implant osteointegration at 3months after implant placement.
    • Evaluation of implant survival and success at 3-, 6-and12-months, 3-and 5- years after implant placement.
    • Rate of all Adverse Device Events (incidence, type, relatedness, severity, seriousness) from the time of grafting procedure up to 5 years after implant placement.
    • Patient satisfaction 6- and 12-months after implant placement.
    • Evaluation of the Sulcus index (peri-implant marginal tissue health status) at 6- and 12-months after implant placement.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • Recruiting
        • Centre Hospitalier Université de Liège
        • Contact:
        • Sub-Investigator:
          • Lemmy Liegeois
        • Sub-Investigator:
          • Gilles Szotek
      • Namur, Belgium, 5020
    • Brabant Wallon
      • Louvain-la-Neuve, Brabant Wallon, Belgium, 1348
        • Recruiting
        • Clinique de la Source DentalMe
        • Contact:
        • Sub-Investigator:
          • Laurane Pansaers
    • Liège
      • Aubel, Liège, Belgium, 4880
      • Chaudfontaine, Liège, Belgium, 4053
        • Recruiting
        • Clinique du Faubourg DentalMe
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • The subject signed the informed consent form;
  • The subject is ≥ 18 and ≤ 80 years old at surgery;
  • The subject is in need of a tooth extraction prior to implant placement;
  • All four bony walls are preserved after extraction;
  • Minimum 8mm height of bone;
  • Minimum 7mm thickness of lingual vestibular;
  • 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%.

Exclusion Criteria:

  • Subject with an acute infection (abscess) at the surgical site;
  • Subject with untreated periodontitis or periodontal disease;
  • Subject with autoimmune diseases or subjects that had received or were currently receiving treatment with antiresorptive drugs (e.g., bisphosphonates), or steroid therapy;
  • Subject who is pregnant or breastfeeding;
  • Subjects is a heavy smoker (>10 cigarettes a day);
  • Subject with an inability to conduct basic oral hygiene (poor oral hygiene and motivation);
  • Subject with metabolic diseases (diabetes, hyperparathyroidism, osteomalacia);
  • Subject with severe renal dysfunction and severe liver disease;
  • Subject with known severe osteoporosis;
  • Subject with multiple sclerosis and/or acromegaly;
  • Subject follows radiotherapy;
  • Subject with psychiatric disorders or under substance abuse (drug or alcohol);
  • Subject who participates in other clinical trials interfering with the present protocol;
  • Mucosal diseases in the areas to be treated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bio-Oss®
Tooth scheduled for extraction will be removed in the least traumatic way. The socket will be filled with the comparator (Bio-Oss® Geistlich, granules 0.25 - 1mm). Two follow up visits to monitor the healing process will take place at 2 and 6 weeks after surgery. Implant placement will be performed 4 months after the regenerative procedure. Implant loading will be allowed after having waited a minimum of 3 months after the implant placement and after a control visit. The implant survival and success will be assessed at 3, 6 and 12 months after implant placement. A long-term follow-up will evaluate the implant survival and success at 3 and 5 years post implant placement.
Device: Tooth extraction and bone graft procedure

The subject will receive a flash dose of 2 gr of amoxicillin or 600 mg of Clindamycin 1 hour before the surgery.

Tooth will be extracted using gentle techniques to guarantee an atraumatic extraction. If the socket presents insufficient bleeding, the clinician must use an appropriate procedure to induce bleeding. The extraction site must be carefully cleaned. Extraction socket will then be filled with WHA or Bio-Oss previously hydrated with saline solution (0.9%). Extraction socket packed with the graft will be covered with a collagen sponge (Geistlich Mucograft® Seal) and sutured (cross suture, Vicryl rapide 4.0).

If required, a limited connective tissue graft can be placed in the vestibular region.

A CBCT scan will be performed after the bone graft procedure, i.e., after the extraction socket and the biomaterial placement, to measure the initial bone width.

The safety of the investigational device will be evaluated.
Experimental: WHA
Tooth scheduled for extraction will be removed in the least traumatic way. The socket will be filled with the investigational device (WHA, granules 0.25- 1.0mm). Two follow up visits to monitor the healing process will take place at 2 and 6 weeks after surgery. Implant placement will be performed 4 months after the regenerative procedure. Implant loading will be allowed after having waited a minimum of 3 months after the implant placement and after a control visit. The implant survival and success will be assessed at 3, 6 and 12 months after implant placement. A long-term follow-up will evaluate the implant survival and success at 3 and 5 years post implant placement.
Device: Tooth extraction and bone graft procedure

The subject will receive a flash dose of 2 gr of amoxicillin or 600 mg of Clindamycin 1 hour before the surgery.

Tooth will be extracted using gentle techniques to guarantee an atraumatic extraction. If the socket presents insufficient bleeding, the clinician must use an appropriate procedure to induce bleeding. The extraction site must be carefully cleaned. Extraction socket will then be filled with WHA or Bio-Oss previously hydrated with saline solution (0.9%). Extraction socket packed with the graft will be covered with a collagen sponge (Geistlich Mucograft® Seal) and sutured (cross suture, Vicryl rapide 4.0).

If required, a limited connective tissue graft can be placed in the vestibular region.

A CBCT scan will be performed after the bone graft procedure, i.e., after the extraction socket and the biomaterial placement, to measure the initial bone width.

The safety of the investigational device will be evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure.
Time Frame: one year
Bone thickness will be measured using CBCT scan 4 months after the bone augmentation procedure and just before implant insertion. The most apical point from the extraction socket defined at baseline will be set as a reference. The vertical reference line will be drawn in the center of the extraction socket crossing the apical reference point. The horizontal reference line is drawn perpendicular to the vertical line crossing the apical reference point. Based on these marks, 3 measurements will be done at 1, 3 and 5 mm from the top of the crest.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the bone density at implant placement.
Time Frame: one year

Assessment of the bone density on the first and second half of the defect at implant placement using a Likert scale at implant placement.

Likert scale:

  1. = soft bone
  2. = medium bone
  3. = hard bone
one year
Evaluation of the implant primary stability.
Time Frame: one year
Implants primary stability determined by using the torque wrench at implant placement.
one year
Assessment of the implant osteointegration after implant placement
Time Frame: 15 months
Taping of the implant and a rotation test will be performed. A torque wrench will be used at 10Ncm for the rotation test.
15 months
Implant survival rate and success evaluated at 3-, 6- and 12-months and 3- and 5- To evaluate implant survival and success 3-, 6- and 12- months and 3- and 5-years after implant placement
Time Frame: 5 years

At 3-, 6- and 12-months and 3- and 5-years after implant placement, implant survival will be assessed by answering if:

  1. The implant remains in the jaw.
  2. The implant is damaged to the extent that it cannot be restored.

The success of the implant will be assessed with the criteria from Buser et al.:

  • Absence of persistent subjective complaints such as pain, foreign body sensation and/or dysesthesia
  • Absence of a peri-implant infection with suppuration
  • Absence of mobility
  • Absence of a continuous radiolucency around the implant
5 years
Collection of all adverse events (AEs) related to the device and/or procedure, and assessment of incidence, type, severity, seriousness
Time Frame: 5 years

At a minimum prior and after implantation, and at each follow-up thereafter, the following treatment-emergent local AEs, namely any local AE for which the start date is on or after the date that the intervention began, will be assessed for severity, seriousness, and relatedness to the device and/or procedure and recorded in the eCRF using standard medical terminology:

  • Pain
  • Flap sloughing
  • Infection
  • Inflammation at the surgical site
  • Swelling at the surgical site
  • Bleeding
  • Bone loss
  • Loss of graft material
5 years
Evaluation of patient satisfaction at 6- and 12-months after implant placement using questionnaire.
Time Frame: 2 years

The questionnaire will focus on the following questions:

  • How satisfied are you with the length of procedures and how they affected your daily functioning?
  • How satisfied are you with the function and aesthetics of the final restoration?
  • How satisfied are you with the pain associated with the treatment?

The scale for each of these questions will be as follows:

0= Not satisfied

  1. Fairly satisfied
  2. Satisfied
  3. Extremely satisfied
2 years
Evaluation of the peri-implant marginal tissue health status at 6 and 12 months after implant placement.
Time Frame: 2 years

Assessment of the peri-implant marginal tissue health status using Sulcus Bleeding Index (mBI)

0= No bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant;

  1. Isolated bleeding spots visible;
  2. Blood forms on a confluent red line on the margin;
  3. Heavy or profuse bleeding.
2 years
Evaluation of the evolution of the interproximal bone level 3- and 12-months after implant placement.
Time Frame: 2 years
The bone to implant neck distance will be evaluated at the mesial and distal aspect from the implant at 3- and 12-months post implant placement.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wishbone SA

Collaborators

EVAMED
Pharmalex
Advimago

Investigators

  • Principal Investigator: Bruno De Carvalho, Clinician

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2024

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2030

Study Registration Dates

First Submitted

April 10, 2024

First Submitted That Met QC Criteria

April 20, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Pre-market parallel study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe