CompletedNot Applicable

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

Pakistan37 participantsStarted 2021-11-01

Plain-language 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.

Who can participate

Age range

12 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Bracket bond failure

Timeframe: Three months

Trial details

NCT IDNCT06602154

SponsorAga Khan University Hospital, Pakistan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-20

View on ClinicalTrials.gov More Orthodontics trials