Clinical Performance of Low Technique Sensitive Self Cured Universal Adhesive Vrs Light Cured Universal Adhesive in Patients With (NCCLs): 18 m RCT

Clinical Performance of Low Technique Sensitive Self-cured Universal Adhesive Versus Light Cured Universal Adhesive in Patients With Non-carious Cervical Lesions (NCCLs): 18 Month Randomized Clinical Trial

This study will be conducted to evaluate the clinical performance of self-cured adhesive versus light cured universal adhesive in non-carious cervical lesions (NCCL) resin composite restorations after 18 month

Study Overview

• Status: Unknown
• Conditions: Non Carious Cervical Lesion
• Intervention / Treatment: Other: light cure 3m single bond universal bond; Other: Self-cure universal bond (Palfique, Tokuyama, Japan)

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• particepant with age rang 18-55
• particepant with non carious cervical lesion

Exclusion Criteria:

• particepant outside age rang
• particepant with periodontal problem that might affect the teeth to be treated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Light cure universal bond; light cured 3m single bond universal	Other: light cure 3m single bond universal bond; light -cure universal bond
Active Comparator: self cure universal bond; self-cure universal bond (Palfique, Tokuyama, Japan)	Other: Self-cure universal bond (Palfique, Tokuyama, Japan); Self-cure universal bond with no light cure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of fracture restoration	Frist visual evaluation to ensure that there is no complete loss of retention of the restoration then tactile evaluation will be done using probe tip that will be held gently at right angle to the labial surface and move from restoration to tooth and vice versa to insure no rocking /fracture /ditching in the restoration following FDI criteria ( first visually for total loss .followed by tactile inspection using fdi prob for any fracture /rocking or loss of retention	18 month
number of restoration with retention loss	Frist visual evaluation to ensure that there is no complete loss of retention of the restoration then tactile evaluation will be done using probe tip that will be held gently at right angle to the labial surface and move from restoration to tooth and vice versa to insure no rocking /fracture /ditching in the restoration following FDI criteria	18-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of restoration with change in colour or texture	Evaluation will be done visually following FDI criteria to ensure no change in colour or texture of the restoration	18 month
Number of restoration caused biological harm	Evaluation will be done following FDI criteria using FDI prob to ensure no change in restoration that caused any harm to the health of biological strucure	18 month

Collaborators and Investigators

• Sponsor: Aya Gamal ashour

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: September 26, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): October 1, 2020
• Last Update Submitted That Met QC Criteria: September 26, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: universal bond; NCCls; 3m single bond universal; Palfique, Tokuyama, Japan; self cure; non carious cervical lesions
• Additional Relevant MeSH Terms: Uterine Diseases; Uterine Cervical Diseases
• Other Study ID Numbers: gsda.1986.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No