TiO2-scaffolds for Alveolar Ridge Preservation (TIOSCAFF)

University of Oslo

Status: Completed

Conditions: Alveolar Bone Resorption

Treatments: Radiation: CBCT; Procedure: Scaffold placement

Study type: Interventional

Funder types: Other

Identifiers

NCT06269497

2018/2300

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Scaffold

Experimental group

Description:

After tooth extraction will one scaffold be placed in the extraction alveola, covered by a membrane and then covered by the gingival tissue.

Treatment:

Radiation: CBCT

Procedure: Scaffold placement