An interventional study of Alkasite bioactive restorative material. and Resin Modified Glass Ionomer in Cervical Lesion, sponsored by Cairo University. Status unknown. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-28.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
Cention N will have the same clinical performance as resin-modified glass ionomer in cervical carious lesions. Evaluation of restorations will be done at baseline, six months, and one year according (USPHS) criteria.
In this study, Class V carious lesions were restored using two different restorative materials either resin modified glass ionomer or Cention N restorative materials. This study will be held in the restorative clinic at Future University in Egypt. Patients will be assessed for medical and dental histories first. Then an examination of the patients will be done using visual inspection by using a dental mirror and probe. Eligible patients according to inclusion and exclusion criteria will be informed about all procedures with follow up time if they accept, 12 their signature on written informed consents will be obtained. Eligible participants will be randomly divided into two groups according to the type of restoration they will be received. The first group (A) will be received resin modified glass ionomer restorative material and the second group (B) will be received Cention N restorative materials. Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline and regular recalls of 6 months and one year.
The restorations will be clinically examined according to modified USPHS criteria in terms of marginal adaptation, anatomic form, color match, marginal discoloration, secondary caries, postoperative sensitivity and retention. The information that will be obtained will be collected and statistically analyzed
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.
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Exclusion criteria:
Intervention Alkasite Restoration will be used to restore cervical carious in adult patients.
Other: Alkasite bioactive restorative material.
Comparator Resin-modified glass ionomer material will be used to restore cervical carious in adult patients.
Other: Resin Modified Glass Ionomer
Alkasite restorative is a category of filling material, like compomer, and is essentially a subgroup of the composite resin. Cention N is a urethane dimethacrylate (UDMA)-based, self-curing powder/liquid restorative with optional additional light curing. The liquid comprises of dimethacrylates and initiators, while the powder contains various glass fillers, initiators, and pigments. It is radio opaque and contains alkaline glass fillers capable of releasing fluoride, calcium, and hydroxide ions. Due to the sole use of cross-linking methacrylate monomers in combination with a stable, efficient self-cure initiator, Cention N displays a high polymer network density and degree of polymerization over the complete depth of the restoration.
Also known as: (Cention N).
The resin-modified glass ionomer materials are hybrid materials of traditional glass ionomer cement with a small addition of light-curing resin, and hence exhibit properties intermediate to the two, with some characteristics superior to conventional glass ionomer materials
(Marginal adaptation)
(USPHS) criteria
Time frame: 12 months
Clinical performance (Anatomical form, Secondary caries, marginal discoloration, Postoperative sensitivity, Color match, Retention)
(USPHS) criteria
Time frame: 12 months
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Cairo University