Microbiological Study on Maxillary Complete Dentures of Two Different Materials

Denture Stomatitis Clinical Trial

Official title:

Microbiological Comparative Study Between Single Maxillary Denture Fabricated From Rapid Heat Cured Resin and Conventional Acrylic Resin Modified by Titanium Dioxide Nanoparticles

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02950623
• Other study ID #: Hozaifa
• Status: Not yet recruiting
• Phase: N/A
• First received: October 23, 2016
• Last updated: October 28, 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

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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2
• Est. completion date: June 2017
• Est. primary completion date: March 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 partially dentate mandibular arch with adequate interarch space.

2. The edentulous ridges should be covered by firm healthy mucosa. 3-Angle class I maxillomandibular relation. 4-Healthy and cooperative patient

Exclusion Criteria:

1. Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than 10 cigarettes per 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), Primary Purpose: Prevention

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	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	6 months	Yes