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Completed

NCT Number: NCT04991064

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.

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Key information

Age range

45 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Oral and Dental Medicine

Cairo, Manyal, 12554, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Assessment of the change in the retention within each type of complete denture.

    Time frame: Assessment will be done Immediately and 1 month after denture insertion within each type of denture.

    It is measured in Newton.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 5, 2021
Registry last updated
Sep 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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