TiO2-scaffolds for Alveolar Ridge Preservation

Not Applicable

Completed

• Conditions: Alveolar Bone Resorption
• Interventions: Procedure: Scaffold placement; Radiation: CBCT

• Registration Number: NCT06269497
• Lead Sponsor: University of Oslo

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.

Study Timeline

• Study Start: 2021-11-09
• Primary Completion: 2022-06-20
• Study Completion: 2023-08-10
• Study First Submitted: 2023-11-30
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-12
• Last Update Submitted: 2024-02-12
• Study First Posted: 2024-02-21
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Scaffold	CBCT	After tooth extraction will one scaffold be placed in the extraction alveola, covered by a membrane and then covered by the gingival tissue.
Scaffold	Scaffold placement	After tooth extraction will one scaffold be placed in the extraction alveola, covered by a membrane and then covered by the gingival tissue.

Primary Outcome Measures

Name	Time	Method
Adverse reactions	Through study completion, an average of 1 year	Evaluate and register any adverse reactions following placement of the scaffold

Secondary Outcome Measures

Name	Time	Method
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.
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.
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

Trial Locations

Locations (1)

Faculty of Dentistry, University of Oslo; 🇳🇴 Oslo, Norway