Mycological Comparative Study on Maxillary Dentures of Two Different Materials

October 7, 2018 updated by: Ali ibrahim mahmoud shamardal

Mycological Comparative Study Between Single Maxillary Denture Fabricated From Rapid Heat Cure Acrylic Resin Material and Conventional Acrylic Resin Material Modified by Titanium Dioxide Nanoparticles

Cross over design the investigator divide participants to two groups group (A) will receive rapid heat cured denture base material and group (b) will receive the acrylic denture modified by titanium dioxide nanoparticles and after washout period alternatively group (a) will receive the acrylic denture modified by titanium dioxide nanoparticles AND group (b) will receive rapid heat cured denture base material the investigator will take swaps from dentures to count the candida species

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Completely edentulous maxillary arch and partially dentate mandibular arch with adequate interarch space.
  • The edentulous ridges should be covered by firm healthy mucosa.
  • Angle class I maxillomandibular relation.
  • Healthy and cooperative patient

Exclusion Criteria:

  • Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than 10 cigarettes per day).
  • Previous history of radiotherapy or chemotherapy.
  • Any skeletal problem dictates surgical intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: patients take titanium dioxide denture
patients will receive titanium dioxide denture (made from conventional acrylic resin modified by titanium dioxide nanoparticles ) for 1 month in the initial phase of the trial then in the later phase after one month they will receive( rapid heat cured acrylic resin)denture
Other: titanium dioxide denture
patients will receive titanium dioxide denture (made from acrylic resin with titanium dioxide nanoparticles ) for 1 month in the initial phase then in the second phase after one month they will receive( rapid heat cured acrylic resin)denture according to the principle of crossover des
PLACEBO_COMPARATOR: patients take rapid heat denture
patients will receive rapid heat denture for 1 month in the initial phase of the trial then in the later phase patients will receive titanium dioxide denture (made from conventional acrylic resin modified by titanium dioxide nanoparticles )
Other: titanium dioxide denture
patients will receive titanium dioxide denture (made from acrylic resin with titanium dioxide nanoparticles ) for 1 month in the initial phase then in the second phase after one month they will receive( rapid heat cured acrylic resin)denture according to the principle of crossover des

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mycological investigation
Time Frame: 6 months
Count of candida on the fitting surface of denture by (CFU) unit
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ali ibrahim mahmoud shamardal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 20, 2018

Primary Completion (ANTICIPATED)

May 1, 2019

Study Completion (ANTICIPATED)

June 1, 2019

Study Registration Dates

First Submitted

September 26, 2018

First Submitted That Met QC Criteria

October 7, 2018

First Posted (ACTUAL)

October 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 7, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Acrylic vs Tio2 reinforced

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Effect of Tio2 Nanoparticles on Candida Aggregation

Clinical Trials on titanium dioxide denture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe