- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02950623
Microbiological Study on Maxillary Complete Dentures of Two Different Materials
October 28, 2016 updated by: mohamed mabrouk abd Elmawla mahmoud, Cairo University
Microbiological Comparative Study Between Single Maxillary Denture Fabricated From Rapid Heat Cured Resin and Conventional Acrylic Resin 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 anaerobic bacteria.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Anticipated)
2
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 50 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. 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
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 Assignment
- 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
|
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
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
|
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 )
|
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
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiological investigation: Count of anaerobic bacteria on the fitting surface of denture by (CFU) unit
Time Frame: 6 months
|
Microbiological investigation: Count of anaerobic bacteria 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
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
October 1, 2016
Primary Completion (Anticipated)
March 1, 2017
Study Completion (Anticipated)
June 1, 2017
Study Registration Dates
First Submitted
October 23, 2016
First Submitted That Met QC Criteria
October 28, 2016
First Posted (Estimate)
November 1, 2016
Study Record Updates
Last Update Posted (Estimate)
November 1, 2016
Last Update Submitted That Met QC Criteria
October 28, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hozaifa
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.
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