Comparison of Bond Failure with Resin-modified Glass Ionomer Cement and Visible Light-cure Composite Bonding Material in Adult Orthodontic Patients - a Split-Mouth, Randomized Controlled Trial (RMGIC)

September 17, 2024 updated by: Rashna Hoshang Sukhia, Aga Khan University Hospital, Pakistan

In this split mouth study design, 34 orthodontic patients coming for fixed appliance treatment will be bonded with standard light-cure composite bonding material and intervention of Resin Modified Glass Ionomer Cement (RMGIC). Contralateral quadrants will be allocated randomly for either RMGIC or visible light-cure composite bonding in both upper and lower jaw.

Quadrant 1: Randomly selected, contralateral upper and lower quadrants from central incisor to second premolar will be bonded with RMGIC bonding system.

Quadrant 2: Randomly selected, contralateral quadrants from central incisor to second premolar will be bonded with visible light-cure composite bonding material.

Allocation of diagonally opposite quadrants by either bonding system will be assigned randomly. Quadrants to be bonded with Resin-modified glass ionomer cement and light-cure composite bonding material will be switched from patient to patient to ensure randomization. This study is single blinded. The study investigators will not be blinded while the patient will be kept blinded.

On the first visit, a specially designed consent form will be signed by the participant.

Patient interaction for the purpose of study will only be for 1 hour duration while bonding of brackets. After six months amount and location of bond breakages will be evaluated from orthodontic record files.

This study will help us evaluate bond strength of RMGIC as compared to light cure composite. RMGIC can also be considered as the choice of material for bonding in high risk caries patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

MATERIAL & METHODS:

Study Design: Experimental study (Randomized Control Trial) Settings: Dental clinics, The Aga Khan University Hospital, Karachi (AKUH) Duration of Study: Patients will be recruited in this study for one and half hour. Chart analysis of these patients will then be done after six months of recruitment.

Sample Size:

Sample size was calculated with OpenEpi (version 3.01) sample size calculator using findings of Hegarty and Macfarlane14 who reported a bond failure percentage of 30% with light-cure adhesive and risk ratio of 2.6 (1.7, 3.9) for RMGIC as compared to resin based light cured composite. Keeping the above risk ratio at level of significance (α) 5% and power of study (1-β) 80%, at least 34 subjects were required for our study. The sample size will be inflated by 10% to account for sample attrition; therefore, a total of 37 subjects will be included in the study.

Sampling Technique: Non-probability consecutive sampling

Sample Selection:

Inclusion Criteria:

  • Patients aged between 18-35 years
  • Patients with fair to good oral hygiene who have no significant sign of gingivitis
  • Healthy patients with no co-morbids such as rheumatic fever, blood dyscrasias, congenital heart disease, or diabetes mellitus
  • Patients with class I, II and III malocclusions
  • All patients who will sign the consent form

Exclusion Criteria:

  • Enamel surface defects
  • Pregnant patients or lactating mothers
  • Syndromic patients
  • Subjects with previous history of orthodontic or functional appliance treatment

DATA COLLECTION PROCEDURE:

Data will be collected by well-organized proforma. (Annexure H) Ethical approval will be taken from the institutional Ethical Review Committee (ERC) before commencement of the study. All those patients who sign an informed consent form (Annexure I) will receive detailed information regarding the study.

Due to ethical considerations, only patients requiring fixed appliance orthodontic treatment will be recruited. In this split mouth study design, contralateral quadrants will be allocated randomly for either Resin-modified glass ionomer cement or visible light-cure composite bonding in both upper and lower jaw. Randomization as per annerxure J Quadrant 1: Randomly selected, contralateral upper and lower quadrants from central incisor to second premolar will be bonded with RMGIC bonding system.

Quadrant 2: Randomly selected, contralateral quadrants from central incisor to second premolar will be bonded with visible light-cure composite.

On the first visit, a specially designed consent form will be signed by the participant. The investigator will unseal the envelope from Clinical Trials Unit (CTU), containing information regarding the participants based on randomization.

Ethical considerations:

Study will be carried out as per guidelines of World Medical Association's Declaration of Helsinki and principles of GCP (Good Clinical Practice). Any modifications in the protocol will be re-submitted to the ERC. The trial will be conducted in compliance with regulations and a copy of the final study protocol will be submitted to ERC.

Consent:

After assessment of eligibility criteria, participants will be included in this study after signing consent form. Consent form will be explained to patient in a separate dental room by investigators to ensure privacy. If patient will be unable to decide then consent form will be given to patient and asked to reply after decision in 7 days. One copy of consent will be given to patient after signing and one copy will be kept with the investigators.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Pakistan
      • Karachi, Pakistan
        • Aga Khan University Hospital
    • Sindh
      • Karachi, Sindh, Pakistan, 75500
        • Aga Khan University Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients aged between 12-35 years
  • Patients with fair to good oral hygiene who have no significant sign of gingivitis
  • Healthy patients with no co-morbids such as rheumatic fever, blood dyscrasias, congenital heart disease, or diabetes mellitus
  • Patients with class I, II and III malocclusions

Exclusion Criteria:

  • Enamel surface defects
  • Pregnant patients or lactating mothers
  • Syndromic patients
  • Subjects with previous history of orthodontic

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control group ( light cure composite )

Product: Denturum Light Cure Band Adhesive (Ortho Organizers). Composition: 4 mg composite adhesive paste and 6 ml Transbond primer. Storage: Stored at room temperature and protected from humidity.

Usage: Steps for light -cure composite bonding are:

  1. Prepare teeth with oil-free pumice, and rinse thoroughly for 15 seconds with water.
  2. Air dry tooth surface for 5 seconds until dry field is maintained and isolate with cotton rolls.
  3. Etch enamel surface with 37% phosphoric acid for 15 seconds.
  4. Rinse the etched surface for 20 seconds to remove the acid and precipitates that might have formed during the etching procedure.
  5. Thoroughly dry etched surface with moisture free air. Tooth surface should appear frosty white, if not than reetch for 5 seconds.
  6. Brush thin uniform amount of primer on every tooth surface.
  7. Apply a small amount of adhesive paste onto bracket base and position the bracket on tooth surface.
  8. After accurately placing bracket on tooth surfac
Other: Resin modified glass ionomer

The product will be stored by investigators at room temperature in lock and key.

Product: Riva light cure RMGIC (HV) Composition: 18 mg orthodontic bonding paste and 6 ml enamel bond resin. Storage: Stored at room temperature and protected from humidity.

Usage: Steps for Resin-modified glass ionomer cement composite bonding:

  1. Prepare all teeth with oil-free pumice, and rinse thoroughly for 15 seconds with water.
  2. Wash thoroughly.
  3. Etch enamel surface with 37% phosphoric acid for 15 seconds.
  4. Rinse the etched surface for 20 seconds to remove the acid and precipitates that might have formed during the etching procedure.
  5. Activate the capsule and immediately mix in an amalgamator. Do not click with applicator before you mix.
  6. Immediately place into capsule applicator and click trigger until paste is seen through the nozzle
  7. Light cure each increment for 20 seconds.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bracket bond failure
Time Frame: Three months
The objective of this study is to compare rate of bond failures with Resin-modified glass ionomer cement and visible light-cure bonding.
Three months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aga Khan University Hospital, Pakistan

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-5282-23281
  • Dr. Aleem Saeed Qureshi (Other Identifier: AKUH)

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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