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

Evaluation of Clinical Performance for Recently Introduced Non Coated Glass Ionomer in Occlusal Caries in Posterior Teeth Compared to Conventional Glass Ionomer With Coating: A Randomized Clinical Trial

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04463342
Enrollment
20
Registered
2020-07-09
Start date
2019-09-03
Completion date
2021-02-10
Last updated
2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Occlusal Caries

Keywords

Occlusal Caries, Glass Ionomer, Tooth colored Restoration, Non-Coated Glass Ionomer, Universal Glass Ionomer

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.

Interventions

COMBINATION_PRODUCTNon 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.

COMBINATION_PRODUCTConventional Glass Ionomer with Coat

Conventional Glass Ionomer with Coat

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Double Blinded (Participant and Outcome assessor)

Intervention model description

Occlusal Caries in Posterior teeth

Eligibility

Sex/Gender
ALL
Age
19 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Distance penetrated by the Explorer at the tooth restoration interfaceduring procedureThe explorer will be drawn across the surface of the restoration toward the tooth
The degree of mismatch from the normal range of tooth shades and translucencyduring procedureVisual inspection to check the proximity of the shade from the natural tooth
Distance penetrated along the restoration in a pulpal directionduring procedureVisual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface marginsduring procedureVisual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time
Area of continuous movement of an explorer across the surface of the restorationduring procedureSurface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface
Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time.during procedureVisual inspection and explorer to check the shape and structure of the restoration
Pain due to dentin hypersensitivity (evaporative stimulus)during procedurePain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026