Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-25 @ 4:43 AM
NCT ID:
NCT02239718
Eligibility Criteria:
Inclusion Criteria:
1. A missing molar tooth that ranges in length from 8-10 mm as judged by the pre-treatment study model. (No more than one per quadrant, if more than one, then different designs will be used in the same mouth.)
2. The patient has been informed of the various treatment options (dental implants, partial dentures, conventional fixed prosthodontics and no treatment) and if the patient has chosen the RBB as their preferred treatment option, they will be invited to participate in the study
3. The patient is available to attend for clinical examination at 6 monthly interviews for a period up to 36 months from the start of the study
4. The patient will have a minimum of 12 occluding pairs of teeth (24 teeth in total)
5. have a natural dentition opposing the planned RBB
6. More than 30% bone support on the tooth abutment(s)
7. Patients will agree to being randomly assigned to one of the two treatment groups, a 2-unit bridge or 3-unit fixed movable bridge
8. The patient will have been informed on the nature of the study and be required to sign a consent form agreeing to undertake treatment in the study
9. The patient is over 18 years old
10. The patient is in sound dental health, ie no active caries and controlled periodontal disease
Exclusion Criteria:
1. Patients with active tooth decay
2. Patients with uncontrolled periodontal disease. RBB abutment with a probing depth greater than 5mm and bleeding on probing
3. Patients with teeth missing opposite to the planned RBB
4. Abutment tooth mobility of 2 or greater (Millers classification)
5. Patients with a known allergy to the dental alloy used to make the RBB, ie. Ni/Cr
6. Patients with debilitating illnesses or complicating medical conditions
7. Non-vital or root treated abutment teeth
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02239718
Study Brief:
Protocol Section:
NCT02239718