Alveolar Bone Resorption
Conditions
Keywords
Scaffold, Bone resorption
Brief summary
The goal of this clinical trial is to evaluate the safety of placing TiO2 scaffolds in alveolar ridge and to evaluate if the scaffold material contributes to maintain the anatomy and the volume of the alveolar process after tooth extraction.
Detailed description
The primary objective of the clinical trial is to evaluate the safety of placing TiO2 scaffolds in alveolar ridge. The secondary objectives are; (1) to assess anatomical changes as measured by intraoral digital scanning at the time of extraction, after 6 months. (2) to evaluate soft tissue inflammation at 1, 2, 4, 12 and 24 weeks post-surgery, (3) to assess the preservation of the alveolar ridge following placement of TiO2 scaffold in the alveolae after tooth extraction, (4) to assess bone mineralization and quantitative healing in bone biopsies obtained at implant installation in the preserved site 6 months following treatment.
Interventions
PROCEDUREScaffold placement
The scaffold is placed in the alveola following extraction
RADIATIONCBCT
A Cone Beam Computer Tomography (CBCT) is taken of the area of interest after surgery
Sponsors
University of Oslo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Observational study / clinical trial
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject must be ≥ 20 years, and present with a molar or premolar planned for extraction
Exclusion criteria
* Individuals with medical conditions that may affect soft tissue or bone metabolism * Previous local radiotherapy * Current use of chemotherapy * Systemic long-term corticosteroid treatment. * Diabetes * Smokers (\> 10 cigarettes/day). * Patients with active of untreated periodontal disease. * Present or past use of bisphosphonate treatment * Pregnant or nursing subjects * \> class 2 according to the ASA (American Society of Anesthesiologists) physical status classification * Acute infection or no apical periodontitis visible on radiograph of tooth planned for extraction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse reactions | Through study completion, an average of 1 year | Evaluate and register any adverse reactions following placement of the scaffold |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anatomy | 6 months after surgery | Evaluate if the anatomy of the alveolar process is maintained or changed, analysis with use of cone-beam-computer-tomography showing the bone at the site immediately after surgery and 6 months after surgery. Any difference in bone volume will be recorded. |
| Inflammation | Through study completion, an average of 1 year | Evaluate if any inflammatory response appeared in the surrounding tissues following placement of the scaffold according to the modified Landry index (Pippi 2017), The inflammation parameters are recorded with yes or no regarding presence. |
| Mineralization | Evaluation of the histology, specimens tasken 6 months after surgery. | Evaluate bone ingrowth and mineralization of the pores in the scaffold material by the use of micro-ct analysis, histology and immune histology |
Countries
Norway
Outcome results
None listed