The Proximal Contact Tightness and Location in Class II Composite Restorations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-24

Study Completion Date

2023-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to investigate consecutive biological changes in proximal contact tightness using digital force gauge and evaluate proximal contact location using cone beam computed tomography between class II direct composite restorations and adjacent teeth after using sectional matrix system and with different contact forming instruments.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of Different Separation Methods on Proximal Contact Tightness and Contour of Compound Class ii

NCT06606379

Proximal Caries

NOT_YET_RECRUITING NA

Three-Year Clinical Performance of Fiber-reinforced Versus Indirect Resin Composite Posterior Restorations

NCT06803537

Occlusal Caries Proximal Caries

ACTIVE_NOT_RECRUITING NA

A Clinical Assessment of Glass Carbomer Cement

NCT03030690

Dental Caries Class II

COMPLETED NA

Clinical Evaluation of Sectional Matrix Versus Circumferential Matrix for Reproduction of Proximal Contact

NCT03795727

Proximal Contact

COMPLETED NA

Internal Fit Evaluation of Indirect Restorations Using Cone Beam CT (CBCT)

NCT04784676

Indirect Restoration of Badly Broken Vital Teeth

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tooth Decay

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will be a randomized control clinical trial in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Each case will be represented by a code and the group name. These will be sealed in a sequentially numbered opaque envelope and the set of envelopes will be given to the senior supervisor. When the investigator wants to enroll a new case, he will notify the supervisor who will take the next inline envelope and will write the name of the participant on it. At the time of intervention implementation, the investigator will open the sealed envelope and retrieve the allocation and apply.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Palodent® plus sectional matrix system "Control group"

Group Type ACTIVE_COMPARATOR

Precontoured sectional matrix EZ COAT

Intervention Type OTHER

All teeth will be treated with (Palodent ® plus sectional matrix system) (sectional matrix, biting ring, plastic diamond wedge)

PerForm™ "Experimental"

Group Type EXPERIMENTAL

PerForm™

Intervention Type OTHER

Treated with (PerForm™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)

Trimax™ "Experimental"

Group Type EXPERIMENTAL

AdDent Trimax™

Intervention Type OTHER

Treated with (AdDent Trimax™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)

Contact Pro™ "Experimental"

Group Type EXPERIMENTAL

Contact Pro™

Intervention Type OTHER

Treated with (Contact Pro™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Precontoured sectional matrix EZ COAT

All teeth will be treated with (Palodent ® plus sectional matrix system) (sectional matrix, biting ring, plastic diamond wedge)

Intervention Type OTHER

PerForm™

Treated with (PerForm™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)

Intervention Type OTHER

AdDent Trimax™

Treated with (AdDent Trimax™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)

Intervention Type OTHER

Contact Pro™

Treated with (Contact Pro™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Presence of proximal caries in CBCT x-ray with score 3 to 4 according to the radiographic International Caries Detection and Assessment System (ICDAS).
* Presence of the antagonist and the adjacent tooth making contact.
* The teeth to be restored had to show no signs of pulpitis but positive sensitivity using endo ice testing.
* Size of the isthmus with no more than 2/3 of the intercuspal distance
* Good oral health and absence of periodontal disease
* Patients who are not suffering from severe systemic diseases or allergies

Exclusion Criteria

* Medically compromised patients
* Clinical signs of bruxism, traumatic malocclusion
* Pregnant or breast feeding at the time of restoration placement
* Intolerance or allergy toward the applied restorative materials

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No