TiO2-scaffolds for Alveolar Ridge Preservation (TIOSCAFF)

February 12, 2024 updated by: Jan Eirik Ellingsen, University of Oslo
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, Postboks 1142 Blindern
        • Faculty of Dentistry, University of Oslo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Scaffold
After tooth extraction will one scaffold be placed in the extraction alveola, covered by a membrane and then covered by the gingival tissue.
Procedure: Scaffold placement
The scaffold is placed in the alveola following extraction
Radiation: CBCT
A Cone Beam Computer Tomography (CBCT) is taken of the area of interest after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse reactions
Time Frame: Through study completion, an average of 1 year
Evaluate and register any adverse reactions following placement of the scaffold
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anatomy
Time Frame: 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.
6 months after surgery
Inflammation
Time Frame: 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.
Through study completion, an average of 1 year
Mineralization
Time Frame: 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
Evaluation of the histology, specimens tasken 6 months after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Investigators

  • Principal Investigator: Jan Eirik Ellingsen, DDS, PhD, University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2021

Primary Completion (Actual)

June 20, 2022

Study Completion (Actual)

August 10, 2023

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Estimated)

February 21, 2024

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/2300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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