Outcomes of Partial Pulpotomy VS Ful Pulpotomy Using MTA in Primary Teeth
Clinical and Radiographic Success of MTA Full Pulpotomy VS MTA Partial Pulpotomy; a Split-mouth Randomized Controlled Trial.
Background: Full pulpotomy has been the treatment of choice for normal or reversibly inflamed exposed pulps in primary molars. However, this approach has its own disadvantages and may be simplified down to a more conservative type of pulpotomies which is the "partial pulpotomy".
Though the literature is still lacking high quality studies on partial pulpotomy in primary molars.
Since MTA has demonstrated the highest success in the literature in comparison to other pulpotomy agents, it is going to be the choice in this trial. Aims: This study aims to investigate the success of partial vs full pulpotomies using MTA in vital primary molars without irreversible pulpitis. Methods: This is an RCT with a split-mouth design, comparing the radiographic and clinical changes of full vs partial MTA-pulpotomies over a one-year period in primary molars. The study will involve 25 healthy children, aged 4-8 years, who are attending JUST postgraduate clinics for dental treatment. Children with pair-matched primary molars that are present with advanced caries exposing the pulp or requiring pulpotomy will be enrolled. Teeth will be randomly assigned to either full or partial pulpotomy. Both procedures will be conducted under LA and rubber dam isolation.
The whole coronal pulp is going to be removed in full pulpotomy compared to 1-3 mm of the coronal pulp in partial pulpotomy. For both procedures, MTA will be placed, then the tooth will be restored with IRM, with the SSC as the final restoration. Afterwards, participants are going to be followed up clinically every 3 months, and radiographically every 6 months over the study period.
Expected results: partial pulpotomy is expected to be a viable alternative to the full pulpotomy, Partial pulpotomy might be recommended as a treatment option since it is more conservative to the pulp and involves less damage to the hard tissues rendering the tooth easier to restore. More importantly, the procedure is assumed to be less painful and more acceptable to young children with limited cooperation
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Irbid, Jordanië, 22110
- Jordan University of Science and Technology
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Children aged 4-8 years
- Medically fit or with mild systemic disease (ASA I or II),
- Able to attend all follow-up appointments
- Children with deeply carious pair-matched primary molars with normal or reversibly inflamed pulp that are indicated for pulpotomy (with almost radiographic caries exposure of the pulp).
- Children who are willing to take part in the study
- Children with valid parental consent
Exclusion Criteria:
- History of lingering or nocturnal pain, any clinical sign of pulp degeneration such as pathological mobility, tenderness to percussion/palpation, presence of fistulae or odontogenic facial swelling.
- The presence of radiologic signs of pulp infection/necrosis such as pathological external root resorption, internal resorption, bifurcation of apical radiolucency.
- Teeth with developmental dental anomalies, unrestorable crown or with advanced physiologic root resorption (> 1/3).
- Children with known allergy to any of the materials or medicaments used in the study.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Volledige pulpotomie
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Use for partial pulpotomy in primary molars
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Experimenteel: Partial pulpotomy
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Use for partial pulpotomy in primary molars
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Clinical success
Tijdsspanne: 12 months
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Clinical evaluation will include the following parameters: pain, mobility, tenderness to percussion, periodontal pocket formation, gingival inflammation, and sinus tract formation.
Each tooth was scored from 1 to 4 according to the criteria by Zurn and Seale 2008
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12 months
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Radiographic Success
Tijdsspanne: 12 months
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Radiographic evaluation will include the following parameters: periapical or furcal radiolucency, internal resorption, and external resorption.
Each tooth was scored from 1 to 4 according to the criteria by Zurn and Seale 2008
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12 months
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Medewerkers en onderzoekers
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 20240554
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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