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

NCT ID: NCT05054673

Last Updated: 2021-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2022-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Universal Adhesive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Triple (Participant, Investigator, Outcomes assessor)

Study Groups

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intervention

PALFIQUE universal adhesive (Tokuyama self-cure universal adhesive)

Group Type EXPERIMENTAL

universal adhesive

Intervention Type OTHER

PALFIQUE universal adhesive

control

3M™ ESPE™ single bond Universal Adhesive

Group Type ACTIVE_COMPARATOR

universal adhesive

Intervention Type OTHER

3M™ ESPE™ single bond Universal Adhesive

Interventions

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universal adhesive

PALFIQUE universal adhesive

Intervention Type OTHER

universal adhesive

3M™ ESPE™ single bond Universal Adhesive

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Maysaa Mahmoud Mostafa Saad

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Maysaa M Mostafa, B.D.S.

Role: CONTACT

01001422220 ext. 002

Other Identifiers

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palfique bond

Identifier Type: -

Identifier Source: org_study_id

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