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

NCT04463342 | Completed Phase 1 DMC

• 1 other identifier: CairoU-MMEldamanhoury
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Occlusal Caries

Keywords

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

Outcome Measures

Primary Outcomes (28)

• 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

• 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

• 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

• 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 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

• 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

• 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

• 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 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

• 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

Study Arms (2)

Non Coated Glass Ionomer

EXPERIMENTAL

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

Conventional Glass Ionomer with Coat

ACTIVE COMPARATOR

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

Interventions

Non Coated Glass Ionomer 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.

Also known as: Ketac Universal Aplicap- Glass Ionomer Restorative

Non Coated Glass Ionomer

Conventional Glass Ionomer with Coat COMBINATION_PRODUCT

Conventional Glass Ionomer with Coat

Conventional Glass Ionomer with Coat

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with poor oral hygiene. According to DMF or ADA criteria.
• The presence of any para functional habit.
• Abnormal occlusion.
• Any regurgitation problem.
• Subjects with compromised medical history.
• Pulpitis, non-vital or endodontically treated teeth.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Manial, 00202, Egypt

Location

Study Officials

• Mahmoud M Eldamanhoury, Master

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double Blinded (Participant and Outcome assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Occlusal Caries in Posterior teeth

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 9, 2020
• Study Start: September 3, 2019
• Primary Completion: January 10, 2020
• Study Completion: February 10, 2021
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: expecting to have all the data during January or February 2021
• Access Criteria: IPD through contacting the main author Mahmoud.eldamanhory@dentistry.cu.edu.eg.com

Locations

EG (1)