Clinical trial NCT06602154: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontics
Bracket Bonding
Malocclusion; Displaced or Missing Teeth
Keywords: Resin-modified glass ionomer cement
Light cure composite
bracket bonding
Lead sponsor: Aga Khan University Hospital, Pakistan
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 37
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: MATERIAL \&amp; 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.

Eligibility criteria: 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

Primary outcomes:
measure: Bracket bond failure
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
Study officials:
References: