MTA/FS Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial (MTA/FS)
5 februari 2016 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
70
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Ontario
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Toronto, Ontario, Kanada, M5G 1X8
- The Hospital for Sick Children
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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
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
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: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcome at 12 Months Post-procedure.
Tidsram: 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.
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 12 Months Post-procedure.
Tidsram: 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.
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Peter Judd, DDS, The Hospital for Sick Children, Toronto Canada
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
1 september 2010
Primärt slutförande (Faktisk)
1 maj 2014
Avslutad studie (Faktisk)
1 september 2014
Studieregistreringsdatum
Först inskickad
18 december 2013
Först inskickad som uppfyllde QC-kriterierna
18 december 2013
Första postat (Uppskatta)
24 december 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
11 februari 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 februari 2016
Senast verifierad
1 februari 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1000019443
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