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Recruiting NCT06293521

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

Phase II Interventional Deep Caries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pulpotomy, Partial Pulpectomy.
Who it may be relevant to
Registry conditions: Deep Caries. Basic parameters: 4 years — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure Pulpotomy
    After the chamber is deroofed and coronal pulp is amputated using a round-end fissure bur in a high-speed handpiece with adequate water spray and light pressure until canal orifices were reached, The access cavity is flushed with sterile normal saline solution. Saline-wetted cotton pellets were placed for about 5 minutes over amputation sites applying moderate pressure to control pulpal hemorrhage. After discarding the pellets, blood oozing was present, MTA+ Cerkamed will be manipulated in the r
  • Procedure Partial Pulpectomy
    Pulp tissue extirpation is done. Biomechanical preparation is done using rotary files with frequent irrigation with Chlorhexidine. The canals are dried using sterile absorbent paper points followed by obturation by the paste of Zinc oxide and eugenol. The tooth with then be restored with stainless steel crown

Primary outcome measures

  • Radiographic assessment [Time frame: Month 6 , Month 12]
Secondary outcome measures (3)
  • Clinical effectiveness [Time frame: Month 3,Month 6,Month 9,Month 12]
  • Child cooperation [Time frame: Day 0]
  • Time elapsed till final restoration performed [Time frame: Day 0]

Eligibility criteria

Inclusion criteria

  • Aged 4 to 6 years , in good general health
  • The parents provided written informed consent.
  • 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.
  • Restorable teeth.

Exclusion criteria

  • Physical or mental disability.
  • Unable to attend follow-up visits.
  • Previously accessed teeth.
  • Swelling, tenderness to percussion or palpation, or pathological mobility.
  • Pre-operative radiographic pathology such as resorption (internal or external), per-radicular or furcation radiolucency.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo University — Cairo

Identifiers

NCT: NCT06293521 · 06091995

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗