Evaluation of a New Bioactive Material Versus a Fluoride-Releasing Hybrid Restorative Material in Cervical Lesions
One-Year Clinical Evaluation of a Fluoride, Calcium and Phosphate-Releasing New Bioactive Material Versus a Fluoride-Releasing Hybrid Restorative Material in Cervical Lesions: A Randomized Clinical Trial.
- This study will be conducted to evaluate and compare the clinical performance of fluoride, calcium, and phosphate-releasing new bioactive material versus a fluoride-releasing hybrid restorative material in cervical lesions for one-year follow-up.
- The clinical evaluation will be done using modified USPHS criteria at baseline,3,6,9 and 12 months.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
two groups of 30 patients will receive cervical restorations by using calcium and phosphate releasing hybrid restorative material (Activa™ Presto, Pulpdent®, USA), or a fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan). Then these restorations will be evaluated at baseline, 3 months, 6 months, 9 months, and 12 months according to modified USPHS criteria in terms of marginal adaptation, Marginal discoloration, recurrent caries, retention, surface texture, and Post-operative sensitivity.
- Examination and selection of all patients will be done according to inclusion and exclusion criteria.
- A class v cavity will be prepared after local anesthesia has been given as required. Rubber dam isolation followed by the placement of restorative material according to the randomization sequence.
- For the intervention: selective etching to enamel and universal bond agent to all the cavity will be applied first, followed by filling of the cavity with fluoride, calcium, and phosphate-releasing new bioactive material (Activa™ Presto, Pulpdent®, USA) using a 19-gauge applicator tip on the syringe and light-curing for 20 seconds between each 2mm layer.
- For the control group: selective etching to enamel and universal bond agent to all the cavity will be applied first, followed by filling of the cavity with fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan) and will be light polymerized using a light-emitting diode (LED) light-curing unit for 10 seconds between each 2mm layer.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Nourhan K Mohamed, B.D.S
- Telefoonnummer: 01003787886
- E-mail: nourhankhaled@dentistry.cu.edu.eg
Studie Locaties
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Maadi
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Cairo, Maadi, Egypte, 11728
- Nourhan Khaled Mohamed Samir
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Contact:
- Nourhan K Mohamed, B.D.S.
- Telefoonnummer: 002 01003787886
- E-mail: Nourhankhaled@dentistry.cu.edu.eg
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Hoofdonderzoeker:
- Nourhan K Mohamed, B.D.S
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
a)Inclusion Criteria of participants:
- Male or female gender.
- Only co-operative patients will be approved to participate in the trial.
- Medically free adult patients.
- The age range of the patients is 18-40 years. b)Inclusion Criteria of teeth:
- Small to moderate cervical lesion.
- Vital upper or lower teeth with no signs of irreversible pulpitis.
- Caries extension shouldn't exceed mesiodistal width and inciso(occluso)-gingival length not exceed incisal (occlusal) one third.
Exclusion Criteria:
a)Exclusion criteria of participants:
- Allergic history concerning methacrylates
- Pregnancy
- Heavy smoking; xerostomia
- Lack of compliance
- Patients with disabilities.
- Patients having systemic diseases or severe medically compromised.
Patients with severe bruxism, clenching, or temporomandibular joint disorders.
b)Exclusion criteria of the teeth:
- Deep defects (close to the pulp, less than 1 mm distance).
- Periapical pathology or signs of pulpal pathology.
- Possible prosthodontic restoration of teeth.
- Heavy occlusion and occlusal contacts or history of bruxism.
- Pulpitis, non-vital or endodontically treated teeth.
- Sever periodontal affection.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Fluoride, calcium and phosphate-releasing new bioactive material (Activa™ Presto, Pulpdent®, USA).
ACTIVA Presto is a novel bioactive material with a mineral-enriched hydrophilic resin base and a patented rubberized component that resists abrasion and wear with high release and recharge of not only fluoride but also calcium and phosphate ions.
It doesn't contain BIS-GMA, Bisphenol A, or BPA derivatives.
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A class v cavity will be prepared after local anesthesia has been given as required.
Rubber dam isolation will be done.
Selective enamel etching and a universal adhesive agent (Beautibond, Shofu, Japan) will be applied over all the cavity surfaces.
Followed by, placement of restorative material according to the randomization sequence.
Finally, restoration finishing and polishing will be done.
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Actieve vergelijker: Fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan).
Giomer is a hybrid restorative material that contains a resin base and pre-reacted glass ionomer.
S-PRG (surface reaction type) technology provides some properties of GI such as fluoride release and recharge which helps prevent recurrent caries.
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A class v cavity will be prepared after local anesthesia has been given as required.
Rubber dam isolation will be done.
Selective enamel etching and a universal adhesive agent (Beautibond, Shofu, Japan) will be applied over all the cavity surfaces.
Followed by, placement of restorative material according to the randomization sequence.
Finally, restoration finishing and polishing will be done.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Marginal adaptation
Tijdsspanne: one year
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The restoration will be clinically assessed by visual inspection and explorer. Restorations will be given a score using modified USPHS criteria: Alfa: Closely adapted, no visible crevice Bravo: Visible crevice, the explorer will penetrate Charlie: Crevice in which dentin is exposed |
one year
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Marginal Discoloration
Tijdsspanne: one year
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Clinical evaluation by visual inspection and mirror if needed using modified USPHS criteria. Restorations will be given the score: Alfa if No discoloration Bravo if Non penetrating marginal discoloration which can be polished away Charlie if Discoloration with penetration in pulpal direction. |
one year
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Retention
Tijdsspanne: one year
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Clinical evaluation by visual inspection and explorer. Restorations will be given a score according to modified USPHS criteria : Alfa if restoration is retained and there is no loss of restoration. Charlie if loss of restoration. |
one year
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Secondary caries
Tijdsspanne: one year
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Clinical evaluation by visual inspection and explorer. Restorations will be given a score according to modified USPHS criteria: Alfa if no recurrent caries is detected, charlie if recurrent caries is detected. . |
one year
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surface texture
Tijdsspanne: one year
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Clinical evaluation by visual inspection and explorer. Restorations will be given a score according to modified USPHS criteria: Alfa if restoration is enamel-like surface Bravo if Surface rougher than enamel, clinically acceptable Charlie if Surface is unacceptably rough. |
one year
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postoperative sensitivity
Tijdsspanne: one year
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Verbal evaluation by asking the patient. Restorations will be given a score according to modified USPHS criteria: Alfa if not present Bravo if sensitive but diminishing in intensity Charlie if constant sensitivity not diminishing. |
one year
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- cons2021
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
- Full protocol will be published online in Clinicaltrials.gov to avoid repetition, and keep the integrity of the research work.
- Thesis will be discussed and defended in front of a judging committee.
- The study will be published to report the results of this clinical trial.
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
IPD delen Ondersteunend informatietype
- Leerprotocool
- Statistisch Analyse Plan (SAP)
- Formulier voor geïnformeerde toestemming (ICF)
- Klinisch onderzoeksrapport (CSR)
- Analytische code
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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