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

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.

Study Overview

• Status: Unknown
• Conditions: Occlusal Caries
• Intervention / Treatment: Combination product: Non Coated Glass Ionomer; Combination product: Conventional Glass Ionomer with Coat

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Manial
    • Cairo, Manial, Egypt, 00202
      • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Combination product: 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.; Other Names: Ketac Universal Aplicap- Glass Ionomer Restorative
Active Comparator: 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.	Combination product: Conventional Glass Ionomer with Coat; Conventional Glass Ionomer with Coat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The degree of mismatch from the normal range of tooth shades and translucency	Visual inspection to check the proximity of the shade from the natural tooth	6 months
The degree of mismatch from the normal range of tooth shades and translucency	Visual inspection to check the proximity of the shade from the natural tooth	12 months
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins	Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time	6 months
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins	Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time	12 months
Pain due to dentin hypersensitivity (evaporative stimulus)	Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale	6 months
Pain due to dentin hypersensitivity (evaporative stimulus)	Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale	12 months
Area of continuous movement of an explorer across the surface of the restoration	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	6 months
Area of continuous movement of an explorer across the surface of the restoration	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	12 months
Distance penetrated by the Explorer at the tooth restoration interface	The explorer will be drawn across the surface of the restoration toward the tooth	6 months
Distance penetrated by the Explorer at the tooth restoration interface	The explorer will be drawn across the surface of the restoration toward the tooth	12 months
Distance penetrated by the Explorer at the tooth restoration interface	The explorer will be drawn across the surface of the restoration toward the tooth	during procedure
Distance penetrated by the Explorer at the tooth restoration interface	The explorer will be drawn across the surface of the restoration toward the tooth	3 months
The degree of mismatch from the normal range of tooth shades and translucency	Visual inspection to check the proximity of the shade from the natural tooth	during procedure
The degree of mismatch from the normal range of tooth shades and translucency	Visual inspection to check the proximity of the shade from the natural tooth	3 months
Distance penetrated along the restoration in a pulpal direction	Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure	during procedure
Distance penetrated along the restoration in a pulpal direction	Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure	3 months
Distance penetrated along the restoration in a pulpal direction	Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure	6 months
Distance penetrated along the restoration in a pulpal direction	Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure	12 months
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins	Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time	during procedure
Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins	Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time	3 months
Area of continuous movement of an explorer across the surface of the restoration	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	during procedure
Area of continuous movement of an explorer across the surface of the restoration	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	3 months
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.	Visual inspection and explorer to check the shape and structure of the restoration	during procedure
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.	Visual inspection and explorer to check the shape and structure of the restoration	3 months
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.	Visual inspection and explorer to check the shape and structure of the restoration	6 months
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.	Visual inspection and explorer to check the shape and structure of the restoration	12 months
Pain due to dentin hypersensitivity (evaporative stimulus)	Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale	during procedure
Pain due to dentin hypersensitivity (evaporative stimulus)	Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale	3 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mahmoud M Eldamanhoury, Master, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2019
• Primary Completion (Actual): January 10, 2020
• Study Completion (Anticipated): February 10, 2021

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Occlusal Caries; Glass Ionomer; Tooth colored Restoration; Non-Coated Glass Ionomer; Universal Glass Ionomer
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: CairoU-MMEldamanhoury

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Undecided: It is not yet known if there will be a plan to make IPD available.
• IPD Sharing Time Frame: expecting to have all the data during January or February 2021
• IPD Sharing Access Criteria: IPD through contacting the main author Mahmoud.eldamanhory@dentistry.cu.edu.eg.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No