The Anti-microbial Effect of Titanium Dioxide Nano Particles in Complete Dentures Made for Edentulous Patients

NCT03666195 | Unknown DMC

• 1 other identifier: Mona's Protocol
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Although cleaning dentures by immersion in chemical denture cleaning solutions is effective in reducing the number of bacteria, a large number remains adhering to the denture surface. Thus, the mechanical cleansing of dentures is imperative to remove adherent microbes, and prevent diseases. This is not always easy to achieve, due to un-compliant patients, or patients with diminished manual dexterity (e.g. Mani phalanx dysfunction or Rheumatoid Arthritis) that often require assistance in cleaning their dentures, which may not always be available. Therefore, the modification of denture base materials to provide them with antibacterial properties to control oral biofilm formation, and producing dentures that can be cleaned by simply rinsing in water would prove to be valuable in oral hygienic management in complete denture-wearing patients.

Conditions

Candida Infection; Denture Stomatitis

Keywords

Nanoparticles; Titanium dioxide; biofilm; self cleansing; denture plaque; anti microbial

Outcome Measures

Primary Outcomes (1)

• Bacterial Growth

  Bacterial colony forming units

  1 month

Study Arms (2)

Group A

ACTIVE COMPARATOR

complete dentures will be fabricated using poly methyl methacrylate resin denture base material modified with 5%wt titanium dioxide nanoparticles.

Combination Product: Titanium Dioxide Nanoparticles

Group B

NO INTERVENTION

complete dentures will be fabricated with poly methyl methacrylate resin denture base material.

Interventions

Titanium Dioxide Nanoparticles COMBINATION_PRODUCT

incorporating titanium dioxide nanoparticles to PMMA, significantly decreases porosities in the denture resin, rendering titanium dioxide nanoparticles a suitable additive to denture base materials, as it also exhibits anti-microbial effects

Also known as: Ultra fine titanium dioxide, TiO2

Group A

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ranging from 40-70 years.
• Completely edentulous participants.
• Participants with well-developed ridges.
• Compliant participants
• Cooperative participants
• Male or female participants

You may not qualify if:

• Pathological changes of residual ridges.
• Participants with any debilitating disease.
• Participants with uncontrolled diabetes.
• Participants with allergy to resins.
• Participants with allergy to titanium dioxide nanoparticles.
• Participants with severe undercuts, or irregular bony exostosis

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Candidiasis; Stomatitis, Denture

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Stomatitis; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded as well as the statistician and the participant. The outcome assessor will count the bacterial colony forming units without knowing the type of the denture material used (Conventional acrylic resin or acrylic resin modified by titanium dioxide nanoparticles)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Asisstant

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: September 9, 2018
• First Posted: September 11, 2018
• Study Start: October 15, 2018
• Primary Completion: December 15, 2018
• Study Completion: January 15, 2019
• Last Updated: September 11, 2018

Record last verified: 2018-09