the Clinical Performance of a Moisture Resistant, M-TEG-P Phosphate Monomer Based Universal Adhesive (YAMAKIN TMR-Aquabond0) Compared to the Conventional Universal Adhesive (3m ESPE Single Bond Universal Adhesive)

July 19, 2022 updated by: Hend Taha Hanafi Mahmoud, Cairo University

Clinical Performance of a Moisture Resistant, M-TEG-P Phosphate Monomer-based Universal Adhesive in Geriatric Patients With Non-carious Cervical Lesions (NCLLs):A Randomized Clinical Trial

this trial is to test the clinical performance of a novel moisture resistant, M-TEG-P phosphate monomer based universal adhesive (YAMAKIN TMR-Aquabond0) compared to the conventional universal adhesive (3m ESPE Single Bond Universal Adhesive) in geriatric patients with Non-carious Cervical lesions (NCLLs)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

To evaluate the clinical performance of a novel moisture resistant, M-TEG-P phosphate monomer based universal adhesive (YAMAKIN TMR-Aquabond0) compared to the conventional universal adhesive (3m ESPE Single Bond Universal Adhesive) in geriatric patients with Non-carious Cervical lesions (NCLLs)

P: Population: Geriatric patients with non-carious cervical lesions (NCCLs) I: Intervention: Novel moisture resistant, M-TEG-P phosphate monomer based universal adhesive (YAMAKIN TMR-Aquabond0) C: Comparator : 3m ESPE Single Bond Universal Adhesive O: Outcome:Clinical Performance using FDI criteria

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • Egypt
      • Cairo, Egypt, 02022
        • Faculty of Dentistry , Cairo University

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:

  1. Non-carious cervical lesions in anterior and posterior teeth.
  2. Geriatric patients from age 60 years and above.
  3. Patients willing to commit to the whole period of the study.
  4. Males & Females included.

Exclusion Criteria:

  1. Lack of written informed consent to participate
  2. Cervical hypersensitivities
  3. Underage patients
  4. Allergies to components of the materials used
  5. Infectious diseases
  6. Mucosal diseases with unclear diagnosis
  7. Inadequate oral hygiene
  8. Bruxism
  9. High caries activity
  10. Non-vital pulp
  11. Severe periodontal diseases
  12. Severe dysgnathia/traumatic occlusion
  13. Undergoing orthodontic treatments
  14. Undergoing bleaching procedures

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: Yamakin TMR-Aquabond0
Novel Moisture Resistant, M-TEG-P Phosphate Monomer Based Universal Adhesive (YAMAKIN TMR-Aquabond0)
Other: Bonding in NCCLs
bonding agent which can resist moisture and has shorter decalcifying and curing time
Active Comparator: 3m ESPE Single Bond Universal Adhesive
Conventional Universal Adhesive
Other: Bonding in NCCLs
bonding agent which can resist moisture and has shorter decalcifying and curing time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of fractured restorations
Time Frame: 12 months
First, visual inspection to ensure that there is no complete loss of retention of the restoration then tactile evaluation will be done using probe tip that will be held gently at right angle to the labial surface and move from restoration to tooth and vice versa to insure there is no rocking /fracture /ditching in the restoration following FDI criteria ( first visually for total loss followed by tactile inspection using FDI probe for any fracture /rocking or loss of retention.
12 months
Number of restorations with retention loss
Time Frame: 12 months
First, visual inspection to ensure that there is no complete loss of retention of the restoration then tactile evaluation will be done using probe tip that will be held gently at right angle to the labial surface and move from restoration to tooth and vice versa to insure no rocking /fracture /ditching in the restoration following FDI criteria
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of restoration with change in colour or texture
Time Frame: 12 months
Evaluation will be done visually following FDI criteria to ensure no change in colour or texture of the restoration
12 months
Number of restoration caused biological harm
Time Frame: 12 months
Evaluation will be done following FDI criteria using FDI probe to ensure there is no change in restoration that caused any harm to the health of biological structure
12 months

Collaborators and Investigators

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

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

October 13, 2021

Primary Completion (Anticipated)

October 13, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

August 21, 2021

First Submitted That Met QC Criteria

August 26, 2021

First Posted (Actual)

August 31, 2021

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Novel YAMAKIN TMR-Aquabond0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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