NCT03006757

Brief Summary

The purpose of this study is to compare the effect of rapid heat cured acrylic resin material with titanium dioxide nanoparticles added to conventional acrylic resin material on the biting force of the single maxillary complete denture .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 30, 2016

Status Verified

December 1, 2016

Enrollment Period

3 months

First QC Date

December 16, 2016

Last Update Submit

December 29, 2016

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (1)

  • measurement of the biting force of rabid heat cured acrylic resin versus modified conventional acrylic with titanium dioxide nanoparticles in maxillary single denture using i load star sensor

    3 months

Study Arms (2)

Column titanium dioxide

EXPERIMENTAL

patient take titanium dioxide denture 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.

Other: titanium dioxide denture base

column placebo

EXPERIMENTAL

patient will take denture with conventional acrylic ( 20 minutes cure ) for 1 month in the initial phase

Other: titanium dioxide denture base

Interventions

titanium dioxide denture baseOTHER
Column titanium dioxidecolumn placebo

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • completely edentulous maxillary arch and full or partial dentate mandibular arch with adequate inter arch space
  • edentuluos arches should be covered by firm healthy mucosa angle class 1 maxillomandibular relationship

You may not qualify if:

  • patients with bad habits
  • previous history of radiotherapy or chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahmoud Adly

Giza, Giza Governorate, 002, Egypt

RECRUITING

Central Study Contacts

mahmoud adly radwan, master

CONTACT

00201009714746mahmoud_omega@yahoo.com

mahmoud adly radwan, bachelor

CONTACT

00201009714746mahmoud_omega@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal invistigator

Study Record Dates

First Submitted

December 16, 2016

First Posted

December 30, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2016

Study Completion

December 1, 2017

Last Updated

December 30, 2016

Record last verified: 2016-12

Locations

EG(1)