Microbiological Study on Maxillary Complete Dentures of Two Different Materials

NCT02950623 | Unknown DMC

• 1 other identifier: Hozaifa
• Study Type: interventional
• Target: 2
• 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 anaerobic bacteria.

Conditions

Denture Stomatitis

Outcome Measures

Primary Outcomes (1)

• 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

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; 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 partially dentate mandibular arch with adequate interarch space.
• The edentulous ridges should be covered by firm healthy mucosa. 3-Angle class I maxillomandibular relation. 4-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

• Cairo University: lead

MeSH Terms

Conditions

Stomatitis, Denture

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

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: 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: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: November 1, 2016

Record last verified: 2016-10