Evaluation of the Marginal Integrity of Recent Bulk Fill Flowable Composite vs Glass Ionomer for Carious Cervical Restorations: RCCT

Evaluation of the Marginal Integrity of Recent Bulk Fill Flowable Composite vs Glass Ionomer for Carious Cervical Restorations: Randomized Controlled Clinical Trail

The study will be conducted to assess the marginal integrity of different types of restorations (ketac ™ N100 - ketac™ Universal and bulk fill flowable composite) in class v restoration using USPHS criteria.

Study Overview

• Status: Completed
• Conditions: Dental Caries Class v
• Intervention / Treatment: Other: restorative materials

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University
  • Cairo, Egypt, 11555
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Presence of at least one carious buccal cervical lesion.
2. The absence of tooth mobility.
3. Presence of contact with opposite teeth without any abnormal occlusion stress for the selected teeth.
4. Accessible isolation and observable and easily accessible gingival margins during tooth restoration.

Exclusion Criteria:

1. Patients with poor oral hygiene.
2. The presence of any para functional habit.
3. Abnormal occlusion.
4. Any regurgitation problem.
5. Subjects with compromised medical history.
6. Pulpitis, non-vital or endodontically treated teeth.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3M™ Ketac™ Universal Aplicap™; 3M™ Ketac™ Universal Aplicap™ Glass Ionomer Restorative Clean the cavity preparation with water. Rinse thoroughly and dry. Extrude the mixed ketac universal out of the capsule directly into the prepared cavity with a capsule gun. Please ensure that no air bubbles are included. It is recommended that the finishing and polishing can be continued after approximately 4 minutes after the start of the mixing or earlier if heat is applied for faster setting. The finishing and polishing can be done immediately after final setting with Extra-Fine, Friction Grip diamonds under water-cooling.	Other: restorative materials; glass ionomer and bulk fill flowable composite
Experimental: Filtek™ Bulk Fill Flowable composite; Filtek™ Bulk Fill Flowable Restorative is the 3M ESPE choice in the bulk fill flowable category. Selective etching 15-20 s for enamel. The adhesive system (BISCO universal all bond) will be applied following the manufacturer's instructions (apply 2 coats 20 s before curing). Bulk fill flowable composite will be light cured for 40 s using a visible light curing unit.	Other: restorative materials; glass ionomer and bulk fill flowable composite
Active Comparator: ketac N100; Ketac™ Nano Light Curing Glass Ionomer Restorative. Primer will be applied to both enamel and dentinal surfaces for 15 seconds. The prepared tooth surfaces will be wet with the primer for the full application time. Dispensing two clicks from the Clicker™ Dispenser will provide an adequate amount of material for most restorative filling applications. It will be placed with a syringe system then will be placed in 2mm increments or less, and light cured after each increment. An LED curing light will cure all shades with a 20 second light exposure. Finishing Ketac Nano restorative will be polished with conventional finishing and polishing instruments such as a diamond impregnated rubberized polishing system under water spray. A glaze such as Vitremer™ Finishing Gloss will be applied after polishing if desired.	Other: restorative materials; glass ionomer and bulk fill flowable composite

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
is marginal integrity of restoration.	Primary outcome is marginal integrity of restoration. It will be assessed by USPHS; score will be recorded according to USPHS criteria (Nassar et al., 2014). 1. MARGINAL INTEGRITY Alpha (A) Visual inspection and explorer The explorer does not catch when drawn across the surface of the restoration toward the tooth, or, if the explorer does not catch, there is no visible crevice along the periphery of the restoration. Bravo (B) Visual inspection and explorer The explorer catches and there is visible evidence of a crevice, which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure. The dentin and/or the base is not exposed, and the restoration is not mobile. Charlie (C) Explorer The explorer penetrates crevice defect extended to the dentino-enamel junction. Delta (D) Mobile, fractured or missing restoration in a part or total	12 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2019
• Primary Completion (Actual): August 3, 2020
• Study Completion (Actual): October 15, 2020

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 9, 2019
• First Posted (Actual): August 12, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: oper 5215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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.: Yes