NCT04943120

Brief Summary

The aim of the study is to assess the performance of " snow-plow" technique as compared to Bulk Fill technique in restoration of class II cavities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 30, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2023

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

June 21, 2021

Last Update Submit

February 5, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • clinical performance

    USPHS Criteria

    day 1

  • clinical performance

    USPHS Criteria

    3 months

  • clinical performance

    USPHS Criteria

    6 months

  • clinical performance

    USPHS Criteria

    9 months

  • clinical performance

    USPHS Criteria

    12 months

Study Arms (2)

"Snow-Plow" technique

EXPERIMENTAL

In class II cavities, application of X-tra Base bulk fill flowable composite (VOCO) in 1 mm thickness without curing followed by X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. Polymerization as one unit for 20 seconds.

Procedure: "Snow-plow" technique

Bulk Fill technique

ACTIVE COMPARATOR

In class II cavities, application of 4 mm increment of X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. then the restoration id fully polymerized.

Procedure: Bulk fill technique

Interventions

In class II cavities, application of X-tra Base bulk fill flowable composite (VOCO) in 1 mm thickness without curing followed by X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. Polymerization as one unit for 20 seconds.

"Snow-Plow" technique

In class II cavities, application of 4 mm increment of X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. then the restoration id fully polymerized.

Bulk Fill technique

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • class II carious lesions in premolars and molars.
  • Vital upper or lower teeth with no signs of irreversible pulpitis.
  • Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

You may not qualify if:

  • Deep carious defects (close to pulp, less than 1 mm distance).
  • Periapical pathology or signs of pulpal pathology.
  • Endodontically treated teeth
  • Tooth hypersensitivity.
  • Possible prosthodontic restoration of teeth.
  • Heavy occlusion or occlusal contacts or history of bruxism.
  • Severe periodontal affection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry

Cairo, 002, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Main Investigator

Study Record Dates

First Submitted

June 21, 2021

First Posted

June 29, 2021

Study Start

August 30, 2021

Primary Completion

September 1, 2022

Study Completion

February 27, 2023

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations