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

NCT02950584 | Unknown Phase 1 DMC

• 1 other identifier: 89
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Denture Stomatitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patients take titanium dioxide denture

EXPERIMENTAL

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

Other: Titanium dioxide denture; Other: Rapid heat denture

Patients take rapid heat denture

PLACEBO COMPARATOR

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)

Other: Titanium dioxide denture; Other: Rapid heat denture

Interventions

Titanium dioxide denture OTHER

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 take rapid heat denture; Patients take titanium dioxide denture

Rapid heat denture OTHER

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

Patients take rapid heat denture; Patients take titanium dioxide denture

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Stomatitis, Denture

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 23, 2016
• First Posted: November 1, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: June 1, 2017
• Last Updated: November 1, 2016

Record last verified: 2016-10