Retention of Maxillary Complete Dentures Modified With Titanium Dioxide Nanoparticles: A Randomized Crossover Clinical Trial.

This study investigates the effect of the addition of titanium dioxide nanoparticles to denture base materials on their retention compared to that of the unmodified denture base materials.

Study Overview

• Status: Completed
• Conditions: Denture Retention; Complete Dentures
• Intervention / Treatment: Other: Complete denture base modified by Titanium dioxide nanoparticles.

Detailed Description

All patients will be randomly allocated to two equal groups either with the protocol I or II (5 in each group) with an allocation ratio of 1:1 through a computer-generated sequence by a spreadsheet (Excel, Microsoft Office 2010; Microsoft Corp). The group with the protocol I will use the modified dentures with titanium dioxide nanoparticles (TiO2NP) during the first month, followed by no use of the first denture and the use of their old relined dentures instead for 1 month (washout), and then the use of the unmodified dentures for 1 month; the group with the protocol II will use the unmodified dentures during the first month, followed by no use of the first denture and the use of their old relined dentures instead for 1 month (washout), and then the use of the modified dentures TiO2NP for 1 month. Assessment of retention will be done immediately and 1 month after denture insertion.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Manyal
    • Cairo, Manyal, Egypt, 12554
      • Faculty of oral and dental medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients requiring new removable complete dentures, with class I edentulous arches based on the American College of Prosthodontists (ACP) classification15, with an average age of 45-55 years old, with healthy temporomandibular joint, being without systemic disease that could affect the neuromuscular control or salivary flow

Exclusion Criteria:

• Patients with ACP Class II, III, or IV, and xerostomia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: AB arm; participants allocated to this arm receive treatment A first, followed by treatment B.	Other: Complete denture base modified by Titanium dioxide nanoparticles.; Titanium dioxide nanoparticles will be mixed with resin powder of the denture base before mixing the powder and liquid of the heat cure denture base material.
Other: BA arm; participants allocated to this arm receive treatment B first, followed by treatment A.	Other: Complete denture base modified by Titanium dioxide nanoparticles.; Titanium dioxide nanoparticles will be mixed with resin powder of the denture base before mixing the powder and liquid of the heat cure denture base material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the change in the retention within each type of complete denture.	It is measured in Newton.	Assessment will be done Immediately and 1 month after denture insertion within each type of denture.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2017
• Primary Completion (Actual): June 3, 2017
• Study Completion (Actual): June 15, 2017

Study Registration Dates

• First Submitted: July 17, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 17, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Photosensitizing Agents; Dermatologic Agents; Radiation-Protective Agents; Sunscreening Agents; Titanium dioxide
• Other Study ID Numbers: 38912240102212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only the co-author has the IPD. He is responsible to store it in an inaccessible place for anyone.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No