TiO2-scaffolds for Alveolar Ridge Preservation

University of Oslo10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Alveolar Bone Resorption

Interventions

Scaffold placementPROCEDURE

The scaffold is placed in the alveola following extraction

CBCTRADIATION

A Cone Beam Computer Tomography (CBCT) is taken of the area of interest after surgery

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry, University of Oslo

Oslo, Norway

Outcomes

Primary Outcomes

Adverse reactions

Evaluate and register any adverse reactions following placement of the scaffold

Time frame: Through study completion, an average of 1 year

Secondary Outcomes

Anatomy

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.

Time frame: 6 months after surgery

Inflammation

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.

Time frame: Through study completion, an average of 1 year

Mineralization

Evaluate bone ingrowth and mineralization of the pores in the scaffold material by the use of micro-ct analysis, histology and immune histology

Time frame: Evaluation of the histology, specimens tasken 6 months after surgery.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.