- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02950584
Surface Roughness of Heat Cured Acrylic Resin Versus Acrylic Resin With Titanium Dioxide
October 31, 2016 updated by: emad gamal ismail, Cairo University
The Surface Roughness of Rapid Heat Cured Acrylic Resin Versus Modified Conventional Acrylic Resin With Titanium Dioxide Nanoparticles in Maxillary Single Dentures: A Randomized Clinical Trials
Measurement of surface roughness of tow different material of denture base to find out which material is more hygienic by decreasing the amount of bacterial accumulation.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Using a denture base material as a standard value which is the rapid heat cured acrylic resin and compare it with a new material which is a conventional acrylic resin with addition of titanium dioxide nano particles in surface roughness and measuring it by a device called stylus profilometer this will be done on 20 patients this trial will take about 6 months.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 1
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 fully dentate mandibular arch with adequate interarch space.
- The edentulous ridges should be covered by firm healthy mucosa.
- Angle class I maxillomandibular relationship
- Healthy and co-operative patients
Exclusion Criteria:
- Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than 10 cigarettes/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
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients take titanium dioxide denture
Participants 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 |
---|---|---|
The Surface Roughness of the denture base will be measured and reported in micrometer unit
Time Frame: 6 months
|
surface profilometry will be measured by stylus profilometer
|
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)
January 1, 2017
Study Completion (Anticipated)
June 1, 2017
Study Registration Dates
First Submitted
October 23, 2016
First Submitted That Met QC Criteria
October 31, 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 31, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 89
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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