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

NCT06293521 | Recruiting Phase 2 DMC

• 1 other identifier: 06091995
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Deep Caries

Keywords

Irreversible pulpits; Pulpotomy; Pulpectomy

Outcome Measures

Primary Outcomes (1)

• Radiographic assessment

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

  Month 6 , Month 12

Secondary Outcomes (3)

• Clinical effectiveness

  Month 3,Month 6,Month 9,Month 12

• Child cooperation

  Day 0

• Time elapsed till final restoration performed

  Day 0

Study Arms (2)

MTA Pulpotomy

EXPERIMENTAL

Intervention group

Procedure: Pulpotomy

Chlorohexidine Pulpectomy

ACTIVE COMPARATOR

Control group

Procedure: Partial Pulpectomy

Interventions

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.

MTA Pulpotomy

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

Chlorohexidine Pulpectomy

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Pulpotomy

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Central Study Contacts

Nada Mostafa, B.D.S

CONTACT

01117311533; Nadamostafa@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: March 5, 2024
• Study Start: January 1, 2026
• Primary Completion: January 31, 2026
• Study Completion: April 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

EG (1)