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Microbiological Study on Maxillary Complete Dentures of Two Different Materials

Primary Purpose

Denture Stomatitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
titanium dioxide denture
rapid heat denture
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Denture Stomatitis

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Completely edentulous maxillary arch and partially dentate mandibular arch with adequate interarch space.
  2. The edentulous ridges should be covered by firm healthy mucosa. 3-Angle class I maxillomandibular relation. 4-Healthy and cooperative patient

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    patients take titanium dioxide denture

    patients take rapid heat denture

    Arm Description

    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

    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 )

    Outcomes

    Primary Outcome Measures

    Microbiological investigation: Count of anaerobic bacteria on the fitting surface of denture by (CFU) unit
    Microbiological investigation: Count of anaerobic bacteria on the fitting surface of denture by (CFU) unit

    Secondary Outcome Measures

    Full Information

    First Posted
    October 23, 2016
    Last Updated
    October 28, 2016
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02950623
    Brief Title
    Microbiological Study on Maxillary Complete Dentures of Two Different Materials
    Official Title
    Microbiological Comparative Study Between Single Maxillary Denture Fabricated From Rapid Heat Cured Resin and Conventional Acrylic Resin Modified by Titanium Dioxide Nanoparticles
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    March 2017 (Anticipated)
    Study Completion Date
    June 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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 anaerobic bacteria.
    Detailed Description
    First the investigator will take primary impression, and pour it obtain primary cast, then will fabricate special tray an take secondary impression and obtain master cast after that duplication of master cast will be done the investigator will make cross over design.and 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 nanoparticle and after washout period alternatively group (a) will receive the acrylic denture modified by titanium dioxide nanoparticle AND group (b) will receive rapid heat cured denture base material the investigator will take swaps from the different dentures to count the anaerobic bacteria by (CFU).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Denture Stomatitis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    2 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    patients take titanium dioxide denture
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    patients take rapid heat denture
    Arm Type
    Placebo Comparator
    Arm Description
    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 )
    Intervention Type
    Other
    Intervention Name(s)
    titanium dioxide denture
    Intervention Description
    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 design
    Intervention Type
    Other
    Intervention Name(s)
    rapid heat denture
    Intervention Description
    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 ) according to the principle of crossover design
    Primary Outcome Measure Information:
    Title
    Microbiological investigation: Count of anaerobic bacteria on the fitting surface of denture by (CFU) unit
    Description
    Microbiological investigation: Count of anaerobic bacteria on the fitting surface of denture by (CFU) unit
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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. 3-Angle class I maxillomandibular relation. 4-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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Microbiological Study on Maxillary Complete Dentures of Two Different Materials

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