A Phase 1 interventional study of Non Coated Glass Ionomer and Conventional Glass Ionomer with Coat in Occlusal Caries, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 19 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by Cairo University · Phase 1, Interventional, and Treatment
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.
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
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.
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
Conventional Glass Ionomer with Coat
Distance penetrated by the Explorer at the tooth restoration interface
The explorer will be drawn across the surface of the restoration toward the tooth
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months
Plan to share: Yes — Undecided: It is not yet known if there will be a plan to make IPD available.
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Cairo University