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

25 november 2021 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

30

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 40 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Procedur: 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.
Procedur: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Marginal adaptation
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Marginal Discoloration
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Cairo University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Förväntat)

15 december 2021

Primärt slutförande (Förväntat)

15 december 2022

Avslutad studie (Förväntat)

30 december 2022

Studieregistreringsdatum

Först inskickad

25 november 2021

Först inskickad som uppfyllde QC-kriterierna

25 november 2021

Första postat (Faktisk)

8 december 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 december 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 november 2021

Senast verifierad

1 november 2021

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • cons2021

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Ja

IPD-planbeskrivning

  • 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.

Tidsram för IPD-delning

24 months

Kriterier för IPD Sharing Access

open access

IPD-delning som stöder informationstyp

  • Studieprotokoll
  • Statistisk analysplan (SAP)
  • Informerat samtycke (ICF)
  • Klinisk studierapport (CSR)
  • Analytisk kod

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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