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

Not Applicable

Completed

• Conditions: Denture Retention; Complete Dentures
• Interventions: Other: Complete denture base modified by Titanium dioxide nanoparticles.

• Registration Number: NCT04991064
• Lead Sponsor: Cairo University

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.

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 Timeline

• Study Start: 2017-02-12
• Primary Completion: 2017-06-03
• Study Completion: 2017-06-15
• Study First Submitted: 2021-07-17
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-08-05
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-17
• Last Update Posted: 2021-09-20

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BA arm	Complete denture base modified by Titanium dioxide nanoparticles.	participants allocated to this arm receive treatment B first, followed by treatment A.
AB arm	Complete denture base modified by Titanium dioxide nanoparticles.	participants allocated to this arm receive treatment A first, followed by treatment B.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Oral and Dental Medicine; 🇪🇬 Cairo, Manyal, Egypt