TiO2-scaffolds for Alveolar Ridge Preservation

TiO2-scaffolds for Alveolar Ridge Preservation

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.

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.

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.