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
About this trial
This is an interventional prevention trial for Denture Stomatitis
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
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
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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