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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

NCT06602154 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2024-09-19

No results posted yet for this study

Summary

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.

Conditions

  • Orthodontics
  • Bracket Bonding
  • Malocclusion; Displaced or Missing Teeth

Interventions

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.

Sponsors & Collaborators

  • Aga Khan University Hospital, Pakistan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2022-02-20
Completion
2022-02-20

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06602154 on ClinicalTrials.gov