Treatment Outcomes of Pulpotomy Versus Pulpectomy in Vital Primary Molars Diagnosed With Irreversible Pulpitis

NCT06904781 | Not Yet Recruiting

• 1 other identifier: 2025_RCT
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomised controlled trial aims to compare treatment outcomes between pulpotomy and pulpectomy when used to treat vital primary molars diagnosed with symptomatic irreversible pulpitis. Compared to the standard pulpectomy treatment, pulpotomy is a technically simpler procedure, less time consuming, easier for young patients to tolerate, while retaining the proprioceptive sensation of the tooth - all important advantages when treating young children.

Conditions

Irreversible Pulpitis

Keywords

Pulpectomy; Pulpotomy; Vital primary molars; Irreversible pulpitis

Outcome Measures

Primary Outcomes (1)

• Post-treatment clinical outcomes based on presence/absence of pain, tenderness, or signs of infection/pathologic mobility

  Clinical outcome success will be determined at 6-, 12-, and 24-months based on the treated tooth meeting all the below criteria: (i) Treated tooth is not associated with any pain or discomfort; (ii) Treated tooth is not associated with tenderness on percussion or palpation; (iii) Treated tooth is not associated with any swelling, parulis, or fistula; (iv) Treated tooth is not associated with any pathological mobility

  6 months; 12 months; 24 months

Secondary Outcomes (2)

• Post-treatment radiographic outcomes based on presence/absence of pathologic root resorption, new furcal or periapical lesions, or size change of any pre-treatment furcal rarefaction

  6 months; 12 months; 24 months

• Immediate post-treatment pain relief

  24 hours; 7 day

Study Arms (2)

Pulpotomy

EXPERIMENTAL

Participants diagnosed with symptomatic irreversible pulpitis in vital primary molars will receive the pulpotomy treatment intervention

Procedure: Pulpotomy

Pulpectomy

ACTIVE COMPARATOR

Participants diagnosed with symptomatic irreversible pulpitis in vital primary molars will receive the pulpectomy treatment intervention.

Procedure: Pulpectomy

Interventions

Pulpotomy PROCEDURE

Pulpotomy is a conservative pulp treatment option where only the coronal pulp is removed and a bioactive medicament (MTA) is placed over the remnant radicular pulp after haemostasis is achieved.

Pulpotomy

Pulpectomy PROCEDURE

Pulpectomy is treatment procedure in primary teeth where the entire coronal and radicular pulp is extirpated and the root canal system filled with a resorbable material (Vitapex/Metapex)

Pulpectomy

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy (ASA I and II) co-operative children (Frankl Scale + and ++) between the ages of four and nine years.
• Participants have symptoms typical of irreversible pulpitis in one of the primary molars.
• The pulp of the affected primary molar is vital.
• Radicular pulp health is confirmed by attainment of radicular pulp haemostasis within 6 minutes of coronal pulp amputation.
• The affected primary molars can be restored with full coverage stainless steel crowns.
• Any physiologic root resorption, if present, is less than ⅓ the root length.

You may not qualify if:

• Clinical examination of affected primary molar reveals signs of pulpal infection (e.g. pathologic tooth mobility, parulis/fistula, or soft tissue swelling).
• Pre-operative periapical radiograph suggests presence of periapical radiolucency or pathologic root resorption.
• Visual examination of pulp tissue after deroofing reveals signs of necrosis (e.g. avascular/minimally bleeding pulp tissue or yellowish necrotic areas/purulent exudate).
• Signs of extensive radicular pulp inflammation i.e., root pulp bleeding continues even after 6-min.
• Parents not willing to place full coverage crowns post-treatment.
• Clinical diagnosis of irreversible pulpitis between two adjacent primary molars is not sharply defined.
• Unable to perform clinical procedure under rubber dam

Sponsors & Collaborators

• Qatar University: lead
• Jordan University of Science and Technology: collaborator
• Primary Health Care Corporation, Qatar: collaborator
• Cairo University: collaborator
• Christian Dental College: collaborator
• Oral and Dental Teaching Hospital, Libya: collaborator

MeSH Terms

Interventions

Pulpotomy; Pulpectomy

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• Nebu Philip, MDS, PhD

  Qatar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nebu Philip, MDS, PhD

CONTACT

+974-44037319; nphilip@qu.edu.qa

Hani Nazzal, PhD

CONTACT

+974-44037809; hnazzal@hamad.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Non-inferiority randomised controlled trial

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share