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NCT Number: NCT06293521

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

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

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Key information

Conditions

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cairo University

Cairo, Egypt

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulpotomy

Procedure

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 ratio of 3:1 (powder: liquid) to obtain a putty mix. This mix will be placed over the radicular pulp with the help of a suitable sterile amalgam carrier. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet, followed by application of glass ionomer cement.

Partial Pulpectomy

Procedure

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 outcomes

  1. Radiographic assessment

    Time frame: Month 6 , Month 12

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

Secondary outcomes

  1. Clinical effectiveness

    Time frame: Month 3,Month 6,Month 9,Month 12

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

  2. Child cooperation

    Time frame: Day 0

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

    • Rating 5 is definitely positive )
  3. Time elapsed till final restoration performed

    Time frame: Day 0

    Stopwatch , measured in minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Nada Mostafa, B.D.S

CONTACT

[email protected]

01117311533

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2024
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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