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

NCT04053530 | Completed DMC

• 1 other identifier: oper 5215
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Dental Caries Class v

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

3M™ Ketac™ Universal Aplicap™

EXPERIMENTAL

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

Filtek™ Bulk Fill Flowable composite

EXPERIMENTAL

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

ketac N100

ACTIVE COMPARATOR

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

Interventions

restorative materials OTHER

glass ionomer and bulk fill flowable composite

3M™ Ketac™ Universal Aplicap™; Filtek™ Bulk Fill Flowable composite; ketac N100

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Cairo university

Cairo, 11555, Egypt

Location

Cairo University

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysts, statistician and outcome assessor (A.O.) will be blinded after assignment to interventions while the operator will not due to the difference in restorative material presentation and its application protocol.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 3 parallel groups

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 12, 2019
• Study Start: August 4, 2019
• Primary Completion: August 3, 2020
• Study Completion: October 15, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)