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

Primary Purpose

Dental Caries Class v

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
restorative materials
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries Class v

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cairo university
  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

3M™ Ketac™ Universal Aplicap™

Filtek™ Bulk Fill Flowable composite

ketac N100

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 8, 2019
Last Updated
January 25, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04053530
Brief Title
Evaluation of the Marginal Integrity of Recent Bulk Fill Flowable Composite vs Glass Ionomer for Carious Cervical Restorations: RCCT
Official Title
Evaluation of the Marginal Integrity of Recent Bulk Fill Flowable Composite vs Glass Ionomer for Carious Cervical Restorations: Randomized Controlled Clinical Trail
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 4, 2019 (Actual)
Primary Completion Date
August 3, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries Class v

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 parallel groups
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3M™ Ketac™ Universal Aplicap™
Arm Type
Experimental
Arm Description
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.
Arm Title
Filtek™ Bulk Fill Flowable composite
Arm Type
Experimental
Arm Description
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.
Arm Title
ketac N100
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
restorative materials
Intervention Description
glass ionomer and bulk fill flowable composite
Primary Outcome Measure Information:
Title
is marginal integrity of restoration.
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Cairo university
City
Cairo
ZIP/Postal Code
11555
Country
Egypt
Facility Name
Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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