Clinical trial NCT06293521: Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries
Official title: Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Deep Caries
Keywords: Irreversible pulpits
Pulpotomy
Pulpectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Radiographic assessment
timeFrame: Month 6 , Month 12
Secondary outcomes:
measure: Clinical effectiveness
timeFrame: Month 3,Month 6,Month 9,Month 12
measure: Child cooperation
timeFrame: Day 0
measure: Time elapsed till final restoration performed
timeFrame: Day 0
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: