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Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries

Phase 2
Not yet recruiting
Conditions
Deep Caries
Interventions
Procedure: Pulpotomy
Procedure: Partial Pulpectomy
Registration Number
NCT06293521
Lead Sponsor
Cairo University
Brief Summary

This trial aims to compare treatment outcomes between Pulpotomy and Pulpectomy in treating vital primary teeth diagnosed with deep caries with symptoms of irreversible pulpits

Detailed Description

Background: Pulpectomy is the reference treatment for vital primary molars with irreversible pulpitis.Over the past decades, dental caries has unfailingly been the most common chronic infectious disease of childhood and adults. If remained untreated, it can potentially compromise dental pulp tissue. When the dental pulp of primary teeth is irreversibly inflamed, the first treatment choice is pulpectomy, owing to the well-recognized importance of primary tooth retention for child oral/general health. Although a pulpless tooth can remain functional in the oral cavity, modern pediatric endodontics encourages regenerative approaches in primary teeth.The introduction of calcium silicate-based (CS-B) biomaterials such as mineral trioxide aggregate (MTA), along with further understanding of pulp biology and inflammatory processes, has revolutionized treatment modalities for management of irreversible pulpitis in mature permanent teeth. A growing body of evidence has revealed successful implementation of minimally invasive endodontics, that is, vital pulp therapies (VPTs) for management of permanent teeth with irreversible pulpitis even when associated with apical periodontitis. Due to the traditional notion of poorer healing capacity of primary dental pulp, such a paradigm shift has not been seen in pediatric dentistry.Recent research revealed similar vascular/immune responses of primary and permanent dental pulps to caries; therefore, indicating that their healing potential might be this in mind, a reevaluation of traditional approaches for treatment of inflamed primary pulp seems justified.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
40
Inclusion Criteria
  1. Aged 4 to 6 years , in good general health
  2. The parents provided written informed consent.
  3. Clinical characteristics, defined as spontaneous pain and the presence of a deep carious lesion with pulp exposure and bleeding that did not halt within five minutes following removal of the coronal pulp tissue.
  4. Restorable teeth.
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Exclusion Criteria
  1. Physical or mental disability.
  2. Unable to attend follow-up visits.
  3. Previously accessed teeth.
  4. Swelling, tenderness to percussion or palpation, or pathological mobility.
  5. Pre-operative radiographic pathology such as resorption (internal or external), per-radicular or furcation radiolucency.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
MTA PulpotomyPulpotomyIntervention group
Chlorohexidine PulpectomyPartial PulpectomyControl group
Primary Outcome Measures
NameTimeMethod
Radiographic assessmentMonth 6 , Month 12

Absence of periapical radiolucency or absence of internal/ external root resorption

Secondary Outcome Measures
NameTimeMethod
Clinical effectivenessMonth 3,Month 6,Month 9,Month 12

absence of any complication or complementary treatment: Absence of spontaneous pain \& Absence of swelling.

Child cooperationDay 0

Modified frankl scale ,Categorical rating (rating 1 is definitly negative

- Rating 5 is definitely positive )

Time elapsed till final restoration performedDay 0

Stopwatch , measured in minutes

Trial Locations

Locations (1)

Cairo University

🇪🇬

Cairo, Egypt

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