About this trial
Guided Bone Regeneration (GBR) is a widely used technique during dental implant surgery to help rebuild bone around the implant and improve its long-term appearance and stability. This study investigates whether the amount of bone that regrows depends on a person's original bone shape, known as the Individual Phenotypical Dimension (IPD). The aim is to compare the bone stability and overall results between two approaches: adding bone only up to the original bone line (IPD) or adding bone beyond it (over-contour augmentation). Over the course of a year, the study will assess not only bone and soft tissue healing, but also gum blood flow, implant success, and patient satisfaction.
There will be two treatment groups in this study - one group will receive bone grafting just up to their natural bone shape, while the other group will receive a slightly larger graft that extends about 3 mm beyond it. Throughout the study CBCT scans will be taken to assess bone changes around the implant area in order to measure how the bone shape and thickness change over time after surgery.
Eligibility criteria
Qualifiers
Adult (>18 years old) patients
Good medical and psychological health
Engaged patients presenting with a Full Mouth Plaque Score (FMPS) of ≤ 20% within the 6 weeks prior to enrolment
Need of a tooth/teeth replacement in the incisor, canine or premolar maxillary region that could be provided with an implant-supported fixed prosthesis
Disqualifiers
Any known systemic disease severely affecting bone metabolism (e.g., Cushing's syndrome, Crohn's disease, rheumatoid arthritis, osteoporosis or diabetes type I and uncontrolled diabetes type II).
Self-reported HIV or other severe immunosuppression.
Self-reported alcoholism or chronic drug abuse.
Heavy smokers ( > 10 cigarettes/day)
Trial design
Treatments tested in this trial
- Group 1 (Test Group): IP and GBR as an over-contour augmentation beyond IPD
- Group 2 (Control Group): IP and GBR as a contour augmentation up to IPD
Treatment groups
Sponsors and collaborators
Queen Mary University of London
Lead sponsor
University of Belgrade
Collaborator