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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06383377
Other study ID # Pre-market parallel study
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 26, 2024
Est. completion date March 31, 2030

Study information

Verified date May 2024
Source Wishbone SA
Contact Emilie Dory, CEO
Phone +32484706172
Email emilie.dory@wishbone-biotech.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 96
Est. completion date March 31, 2030
Est. primary completion date March 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Belgium Cabinet Debaty-Techy Aubel Liège
Belgium Clinique du Faubourg DentalMe Chaudfontaine Liège
Belgium Centre Hospitalier Université de Liège Liège
Belgium Clinique de la Source DentalMe Louvain-la-Neuve Brabant Wallon
Belgium Centre Oxalys Namur

Sponsors (4)

Lead Sponsor Collaborator
Wishbone SA Advimago, EVAMED, Pharmalex

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure. 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 Assessment of the bone density at implant placement. 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:
= soft bone
= medium bone
= hard bone
one year
Secondary Evaluation of the implant primary stability. Implants primary stability determined by using the torque wrench at implant placement. one year
Secondary Assessment of the implant osteointegration after implant placement 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
Secondary 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 At 3-, 6- and 12-months and 3- and 5-years after implant placement, implant survival will be assessed by answering if:
The implant remains in the jaw.
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
Secondary Collection of all adverse events (AEs) related to the device and/or procedure, and assessment of incidence, type, severity, seriousness 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
Secondary Evaluation of patient satisfaction at 6- and 12-months after implant placement using questionnaire. 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
Fairly satisfied
Satisfied
Extremely satisfied
2 years
Secondary Evaluation of the peri-implant marginal tissue health status at 6 and 12 months after implant placement. 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;
Isolated bleeding spots visible;
Blood forms on a confluent red line on the margin;
Heavy or profuse bleeding.
2 years
Secondary Evaluation of the evolution of the interproximal bone level 3- and 12-months after implant placement. 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
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