Novel Porous Bioceramic Material as a Bone Substitute

  • STATUS
    Recruiting
  • End date
    Mar 14, 2025
  • participants needed
    175
  • sponsor
    Orton Orthopaedic Hospital
Updated on 14 August 2021

Summary

The aim of this study is to demonstrate that new synthetic bone graft bioceramic composites (Adaptos-Si and Adaptos, Biomendex Oy) are able to support the preservation of the alveolar ridge and to promote bone regeneration following dental extraction. New bone graft substitutes are compared with already existing treatment principles used following dental extraction.

The primary hypothesis of the study is that Adaptos-Si granules can reach a clinical outcome superior to that of dental socket left empty after extraction. Secondary aim is that new bioceramic composites can reach a clinical outcome non inferior to the active comparator of this study (Geistlisch Bio-Oss).

Description

The purpose of this study is to evaluate new synthetic Adaptos-Si and Adaptos in ridge preservation bone grafting after dental extraction. This is partly randomized, subject and outcome assessor-blinded, controlled, single center study. The total study duration for each patient is planned to be 10 months. In total 4 visits per patient are scheduled in this study.

Subjects will undergo a single tooth extraction and then will be randomized to receive one of the four bone graft substitutes, which are Adaptos-Si (one of the the two granula sizes), Adaptos, or Geistlich Bio-Oss. Gelatin sponge is applied on the bone graft filled extraction socket. Non-randomized part of the study includes the patients that have chosen the conservative treatment option with dental socket left empty and no intention for dental implant placement. Following a healing period of 5 months, a dental implant will be placed, unless the patient has chosen the empty socket. The subject will be followed for ten months following tooth extraction. Bone ridge horizontal and vertical change assessment will be done by CBCT (primary and secondary outcome) at the time of tooth extraction, and 5 months and 10 months post-extraction.

The study device Bio-Oss (Geistlich Pharma) and Spongostan Absorbable Haemostatic Gelatin Sponge (Ferrosan Medical Devices) are CE-marked. The products are used within the indication.

Details
Condition Alveolar Ridge Preservation
Treatment Adaptos®-Si [0.5-1 mm] (bone grafting surgery), Adaptos®-Si [1-2 mm] (bone grafting surgery), Geistlich Bio-Oss (bone grafting surgery), Tooth extraction without bone graft material, Adaptos® (bone grafting surgery)
Clinical Study IdentifierNCT04719624
SponsorOrton Orthopaedic Hospital
Last Modified on14 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient must have voluntarily signed the informed consent
Females and males, 18 years to 80 years of age
Patient needs single tooth extraction of 1st or 2nd premolar or molar tooth
At least one adjacent teeth present
At least 3 intact walls
Subjects must be committed to the study and the required follow-up visits

Exclusion Criteria

Planned radiation or radiation during previous year in the tooth extraction area
Smoking
Osteoporosis
Uncontrolled periodontitis
Alcohol or drug abuse
Pregnant or breastfeeding women
Uncontrolled diabetes
Local acute or chronic infection or presence of oral lesions or trauma
Immunosuppressive disease, treatment, or medication
Subject is part of the investigator team of this study or investigator's family member
Subject is employee of one of the organizations involve in this study
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note