MTA/FS Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial (MTA/FS)
5. februar 2016 oppdatert av: Peter Judd, The Hospital for Sick Children
Mineral Trioxide Aggregate/Ferric Sulfate Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial
To compare radiographic and clinical outcomes and survival of mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy and root canal therapy (RCT) in carious vital primary maxillary incisors.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Dental caries is the most common chronic disease in children.
Caries of the primary maxillary incisors is common in young children; often necessitating either extraction or pulp therapy.
The premature loss of primary maxillary incisors can adversely affect a child's dental occlusion, ability to properly size food boluses for swallowing, speech articulation, facial esthetics and psychosocial development.
Pulp treatment of cariously exposed vital primary incisors may prevent premature tooth loss as well as eliminate pain.
Currently, there is a paucity of outcome investigations with regard to pulp therapy in primary incisors.
Studietype
Intervensjonell
Registrering (Faktiske)
70
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
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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
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- children with one or more carious primary maxillary incisors where removal of dental caries will likely to produce a vital pulp exposure
- reside in the GTA at time of inclusion
- English-speaking
Exclusion Criteria:
- history of spontaneous or lingering stimulated pain, swelling, fistula or sinus tract, tenderness to percussion and pathological mobility
- incisors with preoperative radiographic evidence of periapical or periradicular radiolucency, a widened periodontal ligament space, physiological resorption, incomplete root formation, internal or external root resorption, pulp canal obliteration or pulp calcifications
- non-restorable tooth
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: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: MTA/FS pulpotomy Group
Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).
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After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed.
A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water.
MTA paste is then used to cover over the exposed amputated pulp surface.
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Aktiv komparator: RCT Group
Children randomized to this group will undergo the root canal therapy (RCT) technique.
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After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed.
The canal will be irrigated with water and then filled with non-reinforced ZOE.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcome at 12 Months Post-procedure.
Tidsramme: 12 months after the procedure
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Two disinterested pediatric dentists classified each treated incisor into one of three outcomes: N=incisor without pathologic change; Po=pathologic change present, follow-up recommended; and Px=pathologic change present, extract.
Incisors rated N or Po were considered an acceptable radiographic outcome while incisors rated as Px were considered unacceptable.
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12 months after the procedure
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Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcomes 18 Months Post-procedure.
Tidsramme: 18 months after the procedure
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Two disinterested pediatric dentists classified each treated incisor into one of three outcomes: N=incisor without pathologic change; Po=pathologic change present, follow-up recommended; and Px=pathologic change present, extract.
Incisors rated N or Po were considered an acceptable radiographic outcome while incisors rated as Px were considered unacceptable.
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18 months after the procedure
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 12 Months Post-procedure.
Tidsramme: 12 months after the procedure
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Pulp treated incisors presenting with spontaneous pain, tenderness to percussion, fistula/sinus tract, soft tissue swelling and/or pathological tooth mobility were considered unacceptable clinical outcomes.
Clinical outcomes between the MTA/FS pulpotomy and RCT groups were compared using Fisher's Exact test.
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12 months after the procedure
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Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 18 Months Post-procedure.
Tidsramme: 18 months after the procedure
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Pulp treated incisors presenting with spontaneous pain, tenderness to percussion, fistula/sinus tract, soft tissue swelling and/or pathological tooth mobility were considered unacceptable clinical outcomes.
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18 months after the procedure
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MTA/FS Pulpotomy and RCT Treated Incisor Survival
Tidsramme: 12 and 18 months
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Kaplan-Meier survival curves were generated for the MTA/FS pulpotomy and RCT treatment groups.
One treated incisor was selected by random draw from each subject for survival analysis to preserve independence of observations.
The log-rank test was used to statistically compare survival of incisors.
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12 and 18 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Peter Judd, DDS, The Hospital for Sick Children, Toronto Canada
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
1. september 2010
Primær fullføring (Faktiske)
1. mai 2014
Studiet fullført (Faktiske)
1. september 2014
Datoer for studieregistrering
Først innsendt
18. desember 2013
Først innsendt som oppfylte QC-kriteriene
18. desember 2013
Først lagt ut (Anslag)
24. desember 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
11. februar 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. februar 2016
Sist bekreftet
1. februar 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1000019443
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