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

NCT04991064 | Completed DMC

• 1 other identifier: 38912240102212
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Denture Retention; Complete Dentures

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

AB arm

OTHER

participants allocated to this arm receive treatment A first, followed by treatment B.

Other: Complete denture base modified by Titanium dioxide nanoparticles.

BA arm

OTHER

participants allocated to this arm receive treatment B first, followed by treatment A.

Other: Complete denture base modified by Titanium dioxide nanoparticles.

Interventions

Complete denture base modified by Titanium dioxide nanoparticles. OTHER

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.

AB arm; BA arm

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Oral and Dental Medicine

Cairo, Manyal, 12554, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 17, 2021
• First Posted: August 5, 2021
• Study Start: February 12, 2017
• Primary Completion: June 3, 2017
• Study Completion: June 15, 2017
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)