Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602154
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-13
Brief 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
Sponsor:
None
Organization:
None
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RMGIC
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
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 301 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 26 17 39 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 Associations 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 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 301 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 26 17 39 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 Associations 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None