Surface Roughness of Heat Cured Acrylic Resin Versus Acrylic Resin With Titanium Dioxide

Denture Stomatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02950584
• Other study ID #: 89
• Status: Not yet recruiting
• Phase: Phase 1
• First received: October 23, 2016
• Last updated: October 31, 2016
• Start date: October 2016
• Est. completion date: June 2017

Study information

• Verified date: October 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Completely edentulous maxillary arch and fully dentate mandibular arch with adequate interarch space.

2. The edentulous ridges should be covered by firm healthy mucosa.

3. Angle class I maxillomandibular relationship

4. Healthy and co-operative patients

Exclusion Criteria:

1. Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than 10 cigarettes/day).

2. Previous history of radiotherapy or chemotherapy.

3. Any skeletal problem dictates surgical intervention

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Denture Stomatitis
• Stomatitis
• Stomatitis, Denture

Intervention

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 design
• 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) according to the principle of crossover design

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Surface Roughness of the denture base will be measured and reported in micrometer unit	surface profilometry will be measured by stylus profilometer	6 months	Yes