Severely Atrophic Jaw Clinical Trial
— VOLCRANOfficial title:
Determination of Bone Volume Changes of the Cranial Bone-augmented Jaw: A Feasibility Study
Verified date | February 2022 |
Source | AZ Sint-Jan AV |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The investigators aim to determine the level of total bone volume remodeling at 6, 24 and 36 months post-surgery in patients who underwent immediate prosthetic rehabilitation through a cranial bone-grafted maxilla in combination with immediate provisional implant (IPI) placement.
Status | Active, not recruiting |
Enrollment | 16 |
Est. completion date | July 2023 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients of all ages - Patients with moderate to extreme bone atrophy of the jaw (class IV to VI according to Cawood and Howell (Cawood & Howell, 1988), caused by terminal periodontitis or edentulism - Patients requiring bone augmentation procedures through cranial bone-grafting for jaw reconstruction - Patients requesting immediate prosthetic rehabilitation, through the placement of an immediate provisional implant (IPI)-supported fixed bridge (immediate loading) Exclusion Criteria: - Patients not fulfilling abovementioned criteria - Patients with severe uncontrollable diabetes - Patients with a smoking habit of >10 cigarettes/day - Patients with severe sinusitis problems - Patients with insufficient cranial bone thickness - Patients with bone remodeling or systemic diseases, or undergoing systematically administered treatments affecting bone remodeling - Patients in whom postoperative complications (e.g. sinusitis, infections) occurred, will be excluded from the analysis, since these could be responsible for short-term bone volume loss confounding long-term results |
Country | Name | City | State |
---|---|---|---|
Belgium | Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV | Bruges |
Lead Sponsor | Collaborator |
---|---|
AZ Sint-Jan AV |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | mean total bone volume changes (%) | 6, 24, and 36 months post surgery | ||
Secondary | correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes | short-term (6 months) | ||
Secondary | correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes | long-term (24 months) | ||
Secondary | correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes | long-term (36 months) | ||
Secondary | correlation between mechanical risk factors, as measured through clinical or radiographical visualization by the treating surgeon and/or prosthodontist, with undesirable bone volume changes | short-term (6 months) | ||
Secondary | correlation between mechanical risk factors, as measured through clinical or radiographical visualization by the treating surgeon and/or prosthodontist, with undesirable bone volume changes | long-term (24 months) | ||
Secondary | correlation between mechanical risk factors, as measured through clinical or radiographical visualization by the treating surgeon and/or prosthodontist, with undesirable bone volume changes | long-term (36 months) | ||
Secondary | incidence of immediate provisional implants loss | up to 6 months | ||
Secondary | incidence of definitive implant loss | up to 36 months |