MedPath

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

Phase 1
Completed
Conditions
Occlusal Caries
Interventions
Combination Product: Conventional Glass Ionomer with Coat
Combination Product: Non Coated Glass Ionomer
Registration Number
NCT04463342
Lead Sponsor
Cairo University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Conventional Glass Ionomer with CoatConventional Glass Ionomer with CoatA 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.
Non Coated Glass IonomerNon Coated Glass IonomerA 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.
Primary Outcome Measures
NameTimeMethod
Distance penetrated by the Explorer at the tooth restoration interface12 months

The explorer will be drawn across the surface of the restoration toward the tooth

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.12 months

Visual inspection and explorer to check the shape and structure of the restoration

The degree of mismatch from the normal range of tooth shades and translucency12 months

Visual inspection to check the proximity of the shade from the natural tooth

Distance penetrated along the restoration in a pulpal direction12 months

Visual 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 margins12 months

Visual 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 restoration12 months

Surface 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

Pain due to dentin hypersensitivity (evaporative stimulus)12 months

Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Cairo University

🇪🇬

Cairo, Manial, Egypt

© Copyright 2025. All Rights Reserved by MedPath