Indirect Pulp Treatment in Primary Molars (RCT)
28. august 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
88
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Cairo, Egypt, 11553
- Faculty of Oral and Dental Medicine
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-
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
4 år til 8 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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:
- Medically free children, their parent(s) accepts to sign the informed consent.
- Age range from 4-8 years.
II-Molars:
- 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).
- Clinically: Normal mobility and normal appearance of gingiva (vital teeth).
- Radiographically: Normal roots without physiological resorption, normal lamina dura and normal periodontal membrane space (indicated for IPT).
Exclusion criteria:
I-Subjects:
- Uncooperative children.
- Parents unable to attend follow up visits (even after explaining the importance of recall visits).
II-Molars:
- History of spontaneous pain (to exclude reversible pulpitis).
- Clinically: Presence of swelling, sinus, fistula or tooth mobility (to exclude non vital teeth).
- Radiographically: Presence of radiolucent lesions at furcation or periapical region or external or internal resorption (to exclude teeth not indicated for IPT).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: IPT using Dycal (TM )
Indirect pulp treatment; IPT using Dycal (TM ); (2 paste system) by partial caries removal
|
Partial caries removal and protection of the dental pulp with biocompatible material
Andre navn:
Partial caries removal and protection of the dental pulp with biocompatible material
Andre navn:
|
|
Eksperimentell: IPT using Vitrebond (TM )
Indirect pulp treatment; IPT using Vitrebond (TM );(powder and liquid) by partial caries removal
|
Partial caries removal and protection of the dental pulp with biocompatible material
Andre navn:
Partial caries removal and protection of the dental pulp with biocompatible material
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Shereen E Taha, Professor, Cairo 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. august 2016
Primær fullføring (Faktiske)
1. august 2017
Studiet fullført (Faktiske)
1. juli 2018
Datoer for studieregistrering
Først innsendt
18. august 2018
Først innsendt som oppfylte QC-kriteriene
7. desember 2018
Først lagt ut (Faktiske)
10. desember 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. august 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. august 2019
Sist bekreftet
1. august 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CEBD-CU-2014-11-3
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
IPD-planbeskrivelse
final results
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Ja
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