Esthetic and Clinical Assessment of Injectable Resin Composite Technique

July 12, 2023 updated by: Tasneem Mokhtar Ali Morad, Cairo University

Esthetic and Clinical Assessment of Injectable Resin Composite Technique Compared to Conventional Layering Technique in Patients With Multiple Spacing in the Maxillary Anterior Teeth Area.

injectable resin composite technique will show a better clinical and esthetic performance compared to conventional layering resin composite technique in patients with multiple spacing in the maxillary anterior teeth area or not.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The injectable composite resin technique is an indirect/direct method that uses a transparent silicone index for accurate and predictable translation of diagnostic wax-up into composite restorations without the need for tooth preparation. The injection molding technique has the advantage of replicating the excellent anatomy defined by a lab-made diagnostic wax-up whereby it would be used for the fabrication of direct restorations, so excellent anatomy results, verifies aesthetics, phonetics, and occlusion, avoids misunderstandings, as it is easy to implement and repair.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Sound and vital upper anterior teeth.
  • Spacing in the maxillary anterior teeth area ranging from .5mm to 2mm.
  • Minor misalignment, correction of peg laterals.

Exclusion Criteria:

  • Non-vital, fractured, or cracked teeth.
  • Teeth with caries or in need of replacement of existing restorations.
  • Rampant caries, atypical extrinsic staining of teeth.
  • Heavy occlusion and occlusal contacts or history of bruxism.
  • Severe periodontal affection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Spacing in the maxillary anterior teeth area treated with injectable resin composite technique.

The injectable composite resin technique is an indirect/direct method that uses a transparent silicone index for accurate and predictable translation of diagnostic wax-up into composite restorations without the need for tooth preparation.

The Spaces will be restored with injectable resin composite.
Procedure: Injectable resin composite technique.
A metal impression tray was filled with transparent vinyl polysiloxane (EXACLEAR, GC) and used to copy the stone model with the wax-up. Then, the replica will be separated from metal tray and a needle-shaped bur will be used to drill holes through the silicone key ending in the middle of the incisal edge. It will be checked whether the holes were large enough to enable the tip of the composite syringe to pass easily and completely. Neighbouring teeth (mesial and distal one) isolated using Teflon tape, as each tooth will individually be restored for establishment of satisfactory contact points. Following etching and rinsing, the tooth dried, and a dental cord (Ultrampak, Ultradent) will be packed into sulcus for mechanical prevention of subgingival composite flow. Then, the transparent silicone index will be placed in the correct intraoral position, and a syringe filled with flowable composite will be inserted through the hole on the incisal edge.
Other Names:
  • Beautiful Flow Plus F03, Medium Viscosity, Shofu Dental
Active Comparator: Spacing in the maxillary anterior teeth area treated with conventional layering composite technique.
shade mapping of enamel and dentin, then isolation the teeth with rubber dam. Palatal index will be done on waxing up and applied against the palatal surface to check the adaptation of the index. Then, the enamel shade adapted on the index in the spacing area. index will be placed back on the anterior teeth to build the palatal wall. A brush will be used to adapt the composite to the margin. After removing excess material, light curing will be carried out for 20 seconds. The Unica matrix (Polydentia) will be used to restore the proximal wall, and to achieve a good seal with the palatal wall. The matrix can be stabilized with a wedge if necessary. Building the proximal wall using the enamel shade, and the incisal halo by using a dentin shade, the frame to layer the core of the restoration will be ready.
Procedure: Conventional layering technique
the palatal surface will be restored by enamel shade; adapted on the index in the spacing area then The Unica matrix (Polydentia) will be used to restore the proximal wall, and to achieve a good seal with the palatal wall. The matrix can be stabilized with a wedge if necessary. Building the proximal wall using the enamel shade, and the incisal halo by using a dentin shade, the frame to layer the core of the restoration will be ready.
Other Names:
  • Enamel and Dentin shades

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Esthetic anatomical form at 6,12,18& 24 months.
Time Frame: T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.
FDI criteria. Possible scores range from 1 (Excellent) to 5 (Immediate replacement necessary).
T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Color match and translucency at 6,12,18& 24 months.
Time Frame: T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.
FDI criteria. Possible scores range from 1 (Excellent) to 5 (Immediate replacement necessary).
T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.
Change from baseline in Surface and marginal staining at 6,12,18& 24 months.
Time Frame: T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.
FDI criteria. Possible scores range from 1 (Excellent) to 5 (Immediate replacement necessary).
T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.
Change from baseline in Surface lustrous at 6,12,18& 24 months.
Time Frame: T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.
FDI criteria. Possible scores range from 1 (Excellent) to 5 (Immediate replacement necessary).
T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Injection Molding Technique

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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