Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393699
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2023-08-29
Brief Title:
Restoration of Non-carious Cervical Lesions With Different Resin Composites and Universal Adhesive
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Restoration of Non-carious Cervical Lesions The Effect of Different Resin Composites Bonded With A Universal Adhesive Utilizing Two Adhesion Approaches A Randomized Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
patients with non carious cervical lesions suffer from dentin sensitivity and presence of cavitations and gingival recession Restoring these lesions with different composites and evaluation of restorations every 6 months will be done to know the effect of different composite types and consistencies in retention of restorations of such lesions
Detailed Description:
A split-mouth randomized clinical trial RCT based on the adhesion strategy will be held on 52 patients attending to the outpatient clinics of the department of operative dentistry Faculty of Dentistry Ain Shams University with 2 non-carious cervical lesions in each side Patients included in this study are those who seek restorative treatment of non-carious cervical lesions NCCLs in premolars and canines which are due to chemical andor mechanical predisposing factors An informed consent will be signed by all participants who will be allocated in this study before being involved in the study Male and female patients will be selected according to the inclusion and exclusion criteria The patients will be randomly assigned into 4 main groups n13 patientsgroup according to the type of restorative material will be inserted In each group two adhesive approaches will be employed either etch-and-rinse ER or self-etching SEapproach For each patients mouth one side will receive restorations with the etch-and-rinse approach n26 restorationsER approach while the other side will receive restorations using the self-etching approach n26 restorationsSE approach This will result in a total of 208 restorations will be inserted in this study A treatment follow-up will be performed every six months for two years to investigate the clinical performance of the different resin composite restorationsthe two different adhesive approaches
Restorations will be evaluated at baseline and every 6 months by two blinded examiners who will not be involved in the study During evaluation the examiners will not be informed about the type of restoration used or the adhesive approach and will have a code for each patient and the restored tooth Restorations will be evaluated according to the modified United State Public Health Service criteria USPHS691330 Primary outcome will be the retention of the restoration but the following secondary outcomes as marginal discoloration and adaptation anatomic form secondary caries texture and postoperative sensitivity will be also evaluated
Restorations will be evaluated at baseline and every 6 months by two blinded examiners who will not be involved in the study During evaluation the examiners will not be informed about the type of restoration used or the adhesive approach and will have a code for each patient and the restored tooth Restorations will be evaluated according to the modified United State Public Health Service criteria USPHS691330 Primary outcome will be the retention of the restoration but the following secondary outcomes as marginal discoloration and adaptation anatomic form secondary caries texture and postoperative sensitivity will be also evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None