Mycological Comparative Study on Maxillary Dentures of Two Different Materials

NCT03700489 | Unknown

• 1 other identifier: Acrylic vs Tio2 reinforced
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief 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 candida species

Conditions

Effect of Tio2 Nanoparticles on Candida Aggregation

Outcome Measures

Primary Outcomes (1)

• Mycological investigation

  Count of candida on the fitting surface of denture by (CFU) unit

  6 months

Study Arms (2)

patients take titanium dioxide denture

EXPERIMENTAL

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

Other: titanium dioxide 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

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 des

patients take rapid heat denture; patients take titanium dioxide denture

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Completely edentulous maxillary arch and partially dentate mandibular arch with adequate interarch space.
• The edentulous ridges should be covered by firm healthy mucosa.
• Angle class I maxillomandibular relation.
• Healthy and cooperative patient

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 per day).
• Previous history of radiotherapy or chemotherapy.
• Any skeletal problem dictates surgical intervention

Sponsors & Collaborators

• Ali ibrahim mahmoud shamardal: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 9, 2018
• Study Start: October 20, 2018
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2019
• Last Updated: October 9, 2018

Record last verified: 2018-10