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

NCT ID: NCT04991064

Last Updated: 2021-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-12
• Study Completion Date: 2017-06-15

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.

Conditions

Denture Retention; Complete Dentures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

AB arm

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

Group Type: OTHER

Complete denture base modified by Titanium dioxide nanoparticles.

Intervention Type: 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.

BA arm

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

Group Type: OTHER

Complete denture base modified by Titanium dioxide nanoparticles.

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amr Gamal Ismail Mohamed

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Oral and Dental Medicine

Cairo, Manyal, Egypt

Countries

Egypt

Other Identifiers

38912240102212

Identifier Type: -

Identifier Source: org_study_id