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Evaluation of a New Bioactive Material Versus a Fluoride-Releasing Hybrid Restorative Material in Cervical Lesions

25. november 2021 opdateret af: Nourhan Khaled Mohamed Samir, Cairo University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Egypten
    • Maadi
      • Cairo, Maadi, Egypten, 11728
        • Nourhan Khaled Mohamed Samir
        • Kontakt:
        • Ledende efterforsker:
          • Nourhan K Mohamed, B.D.S

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Procedure: cervical restoration
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.
Aktiv komparator: 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.
Procedure: cervical restoration
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Marginal adaptation
Tidsramme: one year

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Marginal Discoloration
Tidsramme: one year

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
Retention
Tidsramme: one year

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
Secondary caries
Tidsramme: one year

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
surface texture
Tidsramme: one year

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
postoperative sensitivity
Tidsramme: one year

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cairo University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

15. december 2021

Primær færdiggørelse (Forventet)

15. december 2022

Studieafslutning (Forventet)

30. december 2022

Datoer for studieregistrering

Først indsendt

25. november 2021

Først indsendt, der opfyldte QC-kriterier

25. november 2021

Først opslået (Faktiske)

8. december 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. december 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. november 2021

Sidst verificeret

1. november 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • cons2021

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

  • 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-delingstidsramme

24 months

IPD-delingsadgangskriterier

open access

IPD-deling Understøttende informationstype

  • Studieprotokol
  • Statistisk analyseplan (SAP)
  • Formular til informeret samtykke (ICF)
  • Klinisk undersøgelsesrapport (CSR)
  • Analytisk kode

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Caries i tænderne

Kliniske forsøg med cervical restoration

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Cameroon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner