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Temperature Change of the Pulpal Floor and Restoration With Preheated Resin Composite (A Randomized Clinical Trial)

19. november 2021 oppdatert av: Alshimaa Nasser Mahmoud

clinical evaluation of the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.

Hypothesis: Could the preheated composite affect the temperature of the pulpal floor

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Egypt
      • Minya, Egypt, 61519
        • Faculty of Dentistry - Minia University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

25 år til 45 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Healthy men and women patients of 25-45 years.
  • They should have a good oral hygiene level.
  • Presence of at least two posterior class I or II carious lesions to be restored with two different composite resin restorations.
  • All carious lesions in selected patients didn't close to the pulp in the preoperative radiograph.
  • No preoperative pain.
  • Normal occlusal contact with opposing teeth.
  • No history of periodontal treatment, including periodontal surgery, in the past year.
  • All patients had to sign a written consent before being included.
  • A good likelihood of recall availability.

Exclusion Criteria:

  • patient with severe periodontitis or severe erosion damage.
  • patients with a compromised medical history or had received therapeutic irradiation to the head and neck region.
  • If analgesics or antibiotics had administered by the patient during the past 12 hours preoperatively as it might alter their pain perception.
  • patients reported bruxism or clenching.
  • Greater than grade I mobility or pocket depth greater than 5mm.
  • Non-restorable teeth or hopeless teeth.
  • Immature teeth.
  • Radiographic evidence of external or internal root resorption.
  • Alcoholic and smoker patients.
  • Pregnant or breastfeeding ladies.
  • Patients who had physical disabilities, or who are unable to brush their teeth.
  • Individuals who had sensitive teeth but with one of the following conditions was excluded from the study, teeth with large restoration, abutment of teeth of removable partial dentures, dental restorations, abutment of teeth of removable partial dentures, enamel cracks, leakage of fillings or other restorations teeth, dental pulp lesions, dental abscesses, pulpitis, and atypical facial pain.
  • Patients who had non-carious lesions like attrition, erosion, abrasion or abfraction.
  • Patients had participated in a clinical trial within 6 months before commencement of this trial.
  • Patients unable to return for a recall appointment.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Admira 50º C
in this subgroup the patient's teeth was restored with Admira fusion extra resin composite preheated to 50º C
Annen: preheating of resin composite
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
Andre navn:
  • warming of resin composite
Aktiv komparator: Admira 70º C
in this subgroup the patient's teeth was restored with Admira fusion extra resin composite preheated to 70º C
Annen: preheating of resin composite
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
Andre navn:
  • warming of resin composite
Aktiv komparator: Viscalor 50º C
in this subgroup the patient's teeth was restored with Viscalor resin composite preheated to 50º C
Annen: preheating of resin composite
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
Andre navn:
  • warming of resin composite
Aktiv komparator: Viscalor 70º C
in this subgroup the patient's teeth was restored with Viscalor resin composite preheated to 70º C
Annen: preheating of resin composite
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
Andre navn:
  • warming of resin composite

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
pulpal floor temperature and restoration temperature
Tidsramme: one year

evaluation the effect of preheating BIS GMA free resin composite at different temperature on temperature change of pulpal floor and restoration and compare it with BIS GMA containing resin composite

All readings were taken with the presence of a rubber dam and recorded in Celsius (°C).

Five temperature readings were measured for each tooth; (C0): pulpal floor temperature before beginning the restorative procedure. (C1): pulpal floor temperature during placement of preheated composite. (C2): top composite surface after packing and before curing. (C3): pulpal floor temperature after curing of the preheated composite. (C4): top composite surface after curing. The pulpal floor and the restoration temperature of each tooth was measured by a K-type temperature Probe attached to portable mini type thermometer device
one year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The effect of different preheating temperatures on restoration temperature and pulpal floor temperature
Tidsramme: one year
Five temperature readings were measured for each tooth; (C0): pulpal floor temperature before beginning the restorative procedure. (C1): pulpal floor temperature during placement of preheated composite. (C2): top composite surface after packing and before curing. (C3): pulpal floor temperature after curing of the preheated composite. (C4): top composite surface after curing. The pulpal floor and the restoration temperature of each tooth was measured by a K-type temperature Probe attached to portable mini type thermometer device
one year

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The difference in restoration and pulpal floor temperatures before and after curing of preheated resin composite
Tidsramme: one year
Five temperature readings were measured for each tooth; (C0): pulpal floor temperature before beginning the restorative procedure. (C1): pulpal floor temperature during placement of preheated composite. (C2): top composite surface after packing and before curing. (C3): pulpal floor temperature after curing of the preheated composite. (C4): top composite surface after curing. The pulpal floor and the restoration temperature of each tooth was measured by a K-type temperature Probe attached to portable mini type thermometer device
one year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alshimaa Nasser Mahmoud

Etterforskere

  • Studieleder: Mona I Riad, Professor, Professor at Faculty of Dentistry Cairo University
  • Studieleder: Nermin A Mahmoud, Lecturer, Lecturer at Faculty of Dentistry Minia University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. april 2021

Primær fullføring (Faktiske)

15. juni 2021

Studiet fullført (Faktiske)

28. september 2021

Datoer for studieregistrering

Først innsendt

8. november 2021

Først innsendt som oppfylte QC-kriteriene

19. november 2021

Først lagt ut (Faktiske)

1. desember 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. desember 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. november 2021

Sist bekreftet

1. november 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 490

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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