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

Denture Retention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04991064
• Other study ID #: 38912240102212
• Status: Completed
• Phase: N/A
• Start date: February 12, 2017
• Est. completion date: June 15, 2017

Study information

• Verified date: September 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 15, 2017
• Est. primary completion date: June 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Denture Retention

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Oral and Dental Medicine	Cairo	Manyal

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.