Evaluation of Clinical Performance for Recent Non Coated Glass Ionomer in Posterior Teeth

NCT ID: NCT04463342

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-03
• Study Completion Date: 2021-02-10

Brief Summary

In patients with occlusal caries in posterior teeth, does the use of recently introduced non coated glass ionomer provide better clinical performance compared to conventional glass ionomer with surface coating?

-Primary objective: To evaluate clinical performance of different types of restorations (Ketac molar with coating and Ketac Universal Aplicap 3M without coating) in occlusal caries in posterior teeth.

Detailed Description

The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University; The operator in charge will be Mahmoud Magdy Eldamanhory

Patients will be selected from the outpatient clinic of the department Conservative Dentistry Department, Faculty of Dentistry, Cairo University

• Local anesthesia will be applied to patients complaining about pain or sensitivity to prevent discomfort during restorative procedures.
• Conservative cavity design will be used according to the principals of minimal invasive dentistry.
• All the cavities will be performed by the main author using #57 straight plain carbide fissure bur held in high speed contra-angled hand piece with water cooling system.
• All internal line angles will be slightly rounded.
• Each bur will be discarded after 5 preparations
• If deep caries will be found, it will be removed with large round bur at low speed and a thin layer of calcium hydroxide will be placed on the deep portion of the cavity.
• Isolation will be maintained by using Rubber Dam.
• The dentin and enamel of cavities will be conditioned with 20% polyacrylic acid for 20 seconds (Cavity Conditioner, GC), washed, and briefly dried.
• The restorations will inject into the cavity.
• After the passage of the manufacturer's recommended setting time of 2.5 minutes, the restoration will be trimmed and polished wet using high-speed fine diamonds.

In control group ketac molar with coating:

-After the restoration will briefly dry, Ketac Coat will be applied and photocured for 20 seconds using a photo-curing light.

In study group " Ketac Universal Aplicap 3M without coating":

-The newest addition to glass ionomer family, Ketac Universal Aplicap glass ionomer restorative is a self-cure, one-step placement material designed to help to finish faster. There's no need for conditioning, coating or light-curing steps.

Conditions

Occlusal Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Non Coated Glass Ionomer

A faster, easier procedure is great, but you want assurance that reducing chair time doesn't mean compromising on performance. KetacTM Universal AplicapTM Glass Ionomer Restorative saves time by eliminating the need for a coating-yet still delivers the compressive strength and surface hardness that are higher than several competitive glass ionomers which require one.This advancement is the latest in 3M's 30-year history of developing proven and trusted glass ionomers.

Group Type: EXPERIMENTAL

Non Coated Glass Ionomer

Intervention Type: COMBINATION_PRODUCT

KetacTM Universal AplicapTM Glass Ionomer Restorative saves time by eliminating the need for a coating-yet still delivers the compressive strength and surface hardness that are higher than several competitive glass ionomers which require one.

Conventional Glass Ionomer with Coat

A bulk-fill, packable and fast-setting conventional glass ionomer. Because it's less "technique sensitive" than a composite it's ideal for difficult-to-isolate posterior restoration. High compressive strength and marginal integrity make it a glass ionomer of choice for posterior restorations.Ketac Conditioner Dentin Pretreatment is required; Ketac Glaze Light-Cured Varnish applied on the top of the restoration to avoid moisture contamination.

Group Type: ACTIVE_COMPARATOR

Conventional Glass Ionomer with Coat

Intervention Type: COMBINATION_PRODUCT

Conventional Glass Ionomer with Coat

Interventions

Non Coated Glass Ionomer

KetacTM Universal AplicapTM Glass Ionomer Restorative saves time by eliminating the need for a coating-yet still delivers the compressive strength and surface hardness that are higher than several competitive glass ionomers which require one.

Intervention Type: COMBINATION_PRODUCT

Conventional Glass Ionomer with Coat

Conventional Glass Ionomer with Coat

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Ketac Universal Aplicap- Glass Ionomer Restorative

Eligibility Criteria

Inclusion Criteria

• Presence of at least 2 carious class I in same patient.
• 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.

Exclusion Criteria

1. Patients with poor oral hygiene. According to DMF or ADA criteria.

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Magdy Eldamanhoury

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mahmoud M Eldamanhoury, Master

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo University

Cairo, Manial, Egypt

Countries

Egypt

Other Identifiers

CairoU-MMEldamanhoury

Identifier Type: -

Identifier Source: org_study_id