Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Indirect Pulp Treatment in Primary Molars (RCT)

28. august 2019 opdateret af: Mohamed Farouk Rashed, Cairo University

Evaluation of Resin Modified Glass Ionomer Liner (Vitrebond™) Versus Calcium Hydroxide as Indirect Pulp Treatment Material Used in Deep Carious Lesions in Primary Molars: A Randomized Clinical Trial

This study was conducted to evaluate the clinical and the radiographic success of Dycal and Vitrebond as indirect pulp treatment materials in primary molars.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Evaluation of calcium hydroxide and resin modified glass ionomer liner clinically and radiographically as indirect pulp treatment materials in deep caries in primary molars.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

88

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Egypten
      • Cairo, Egypten, 11553
        • Faculty of Oral and Dental Medicine

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

4 år til 8 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

In compliance with AAPD, 2017 guidelines for pulp therapy "IPT is indicated in a primary tooth with no pulpitis or with reversible pulpitis when the deepest carious dentin is not removed to avoid a pulp exposure. The pulp is judged by clinical and radiographic criteria to be vital and able to heal from the carious insult"

In addition to:

I-Subjects:

  1. Medically free children, their parent(s) accepts to sign the informed consent.
  2. Age range from 4-8 years.

II-Molars:

  1. Presence of at least 1 primary molar with deep carious lesion extending to more than one half of the dentin on radiographic examination (to make the trial regardless of number of carious molars).
  2. Clinically: Normal mobility and normal appearance of gingiva (vital teeth).
  3. Radiographically: Normal roots without physiological resorption, normal lamina dura and normal periodontal membrane space (indicated for IPT).

Exclusion criteria:

I-Subjects:

  1. Uncooperative children.
  2. Parents unable to attend follow up visits (even after explaining the importance of recall visits).

II-Molars:

  1. History of spontaneous pain (to exclude reversible pulpitis).
  2. Clinically: Presence of swelling, sinus, fistula or tooth mobility (to exclude non vital teeth).
  3. Radiographically: Presence of radiolucent lesions at furcation or periapical region or external or internal resorption (to exclude teeth not indicated for IPT).

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
Aktiv komparator: IPT using Dycal (TM )
Indirect pulp treatment; IPT using Dycal (TM ); (2 paste system) by partial caries removal
Medicin: Indirect pulp treatment using Dycal (TM)
Partial caries removal and protection of the dental pulp with biocompatible material
Andre navne:
  • Indirekte pulpafdækning
Medicin: Indirect pulp treatment using Vitrebond (TM )
Partial caries removal and protection of the dental pulp with biocompatible material
Andre navne:
  • Indirekte pulpafdækning
Eksperimentel: IPT using Vitrebond (TM )
Indirect pulp treatment; IPT using Vitrebond (TM );(powder and liquid) by partial caries removal
Medicin: Indirect pulp treatment using Dycal (TM)
Partial caries removal and protection of the dental pulp with biocompatible material
Andre navne:
  • Indirekte pulpafdækning
Medicin: Indirect pulp treatment using Vitrebond (TM )
Partial caries removal and protection of the dental pulp with biocompatible material
Andre navne:
  • Indirekte pulpafdækning

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of cases reporting postoperative pain
Tidsramme: 12 months
Presence of postoperative pain following dental treatment through patient questionnaire as a sign of clinical failure
12 months
Number of cases reporting swelling
Tidsramme: 12 months
Presence of postoperative swelling following dental treatment through visual examination using hand mirror as a sign of clinical failure
12 months
Number of cases reporting sinus
Tidsramme: 12 months
Presence of sinus following dental treatment through visual examination using hand mirror as a sign of clinical failure
12 months
Number of cases reporting fistula
Tidsramme: 12 months
Presence of fistula following dental treatment through visual examination using hand mirror as a sign of clinical failure
12 months
Number of cases reporting tooth mobility
Tidsramme: 12 months
Presence of abnormal tooth mobility following dental treatment through tactile examination using two hand mirrors as a sign of clinical failure
12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of cases reporting external root resorption
Tidsramme: 12 months
Occurrence of pathological external root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
12 months
Number of cases reporting internal root resorption
Tidsramme: 12 months
Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
12 months
Number of cases reporting furcation involvement
Tidsramme: 12 months
Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
12 months
Number of cases reporting widening of periodontal membrane space
Tidsramme: 12 months
Occurrence of widening of periodontal membrane space following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
12 months
Number of cases reporting periapical radiolucency
Tidsramme: 12 months
Occurrence of periapical radiolucency following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
12 months

Samarbejdspartnere og efterforskere

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

Sponsor

Cairo University

Efterforskere

  • Ledende efterforsker: Shereen E Taha, Professor, 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 (Faktiske)

1. august 2016

Primær færdiggørelse (Faktiske)

1. august 2017

Studieafslutning (Faktiske)

1. juli 2018

Datoer for studieregistrering

Først indsendt

18. august 2018

Først indsendt, der opfyldte QC-kriterier

7. december 2018

Først opslået (Faktiske)

10. december 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CEBD-CU-2014-11-3

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

IPD-planbeskrivelse

final results

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mali

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner