Clinical Performance of Self-cured Universal Adhesive for Restoring Cervical Lesions in Geriatric Patients

September 21, 2021 updated by: Maysaa Mahmoud Mostafa Saad, Cairo University

Clinical Performance of Newly Introduced Self-cured Universal Adhesive for Restoring Cervical Lesions in Geriatric Patients Over One Year (A Randomized Clinical Trial)

the study is conducted to evaluate the clinical performance of PALFIQUE universal adhesive (Tokuyama self-cure universal adhesive), Versus 3m ESPE™ single bond Universal Adhesive, for restoring cervical lesions in geriatric patients over one year.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient had to be in good general health
  • Geriatric patients
  • Have an acceptable oral hygiene level
  • Class V cavities in anterior and posterior teeth
  • Males & females included
  • Anticipated availability for recalls (6 months and 12 months) through the 1-year study period

Exclusion Criteria:

  • Lack of written informed consent to participate
  • Poor oral hygiene,
  • Severe bruxism
  • Severe or chronic periodontitis
  • Allergies to components of the materials used
  • Underage patients
  • Non vital pulp

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention
PALFIQUE universal adhesive (Tokuyama self-cure universal adhesive)
Other: universal adhesive
PALFIQUE universal adhesive
Other: universal adhesive
3M™ ESPE™ single bond Universal Adhesive
Active Comparator: control
3M™ ESPE™ single bond Universal Adhesive
Other: universal adhesive
PALFIQUE universal adhesive
Other: universal adhesive
3M™ ESPE™ single bond Universal Adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring the Marginal adaptation
Time Frame: 1 year
modified USPHS criteria, ordinal
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
level of Retention
Time Frame: 1 year
binary , modified USPHS criteria
1 year
Level of Marginal discoloration
Time Frame: 1 year
ordinal, modified USPHS criteria
1 year
Rate of Secondary caries
Time Frame: 1 year
binary , modified USPHS criteria
1 year
level of Postoperative sensitivity
Time Frame: 1 year
binary , modified USPHS criteria
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

September 11, 2021

First Submitted That Met QC Criteria

September 21, 2021

First Posted (Actual)

September 23, 2021

Study Record Updates

Last Update Posted (Actual)

September 23, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • palfique bond

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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