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

NCT ID: NCT06904781

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2028-06-30

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.

Detailed Description

Background: Pulpectomy continues to be the standard treatment recommendation for management of vital primary molars diagnosed with symptomatic irreversible pulpitis. The recent decade has seen a paradigm shift in the treatment concepts of how vital mature permanent molars diagnosed with irreversible pulpitis can be more conservatively managed using vital pulp therapy techniques like pulpotomy. However, despite emerging evidence indicating similarities between primary and permanent tooth pulp response to dental caries, there is limited research on whether pulpotomy can be similarly used as a definitive treatment modality for vital primary teeth with irreversible pulpitis. This randomised controlled trial (RCT) aims to compare the treatment effectiveness of pulpotomy versus pulpectomy in management of vital primary molars diagnosed with symptomatic irreversible pulpitis over a two-year period.

Methods/Design: This clinical study is a parallel, two-armed, open label, non-inferiority RCT with a 1:1 allocation ratio between the experimental intervention arm (pulpotomy) and the active comparator arm (pulpectomy). Healthy cooperative children, between 4-9 years of age, who have painful primary molars with clinical symptoms typical of irreversible pulpitis will be recruited after obtaining informed consent from their parents/legal guardians. 80 vital primary molars clinically diagnosed with symptomatic irreversible pulpitis will be randomly distributed between the two treatment arms. The primary outcomes that will be assessed are clinical success after one-year and two-years of the trial interventions. The influence of baseline pre-operative variables (age; gender; tooth type; site of caries; pre-operative furcal radiolucency; pre-operative pain intensity) and intra-operative factors (time taken to achieve haemostasis) on treatment outcomes will also be assessed. The secondary outcomes evaluated will be the immediate (24 h and 7 d) post-operative pain relief afforded by the two treatment interventions, and the radiographic success after one-year and two-years of the trial interventions.

Discussion: This trial seeks to provide evidence on whether pulpotomy treatment can be no worse than the standard pulpectomy treatment for the management of symptomatic irreversible pulpitis in vital primary molars.

Conditions

Irreversible Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pulpotomy

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

Group Type: EXPERIMENTAL

Pulpotomy

Intervention Type: 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.

Pulpectomy

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

Group Type: ACTIVE_COMPARATOR

Pulpectomy

Intervention Type: 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)

Interventions

Pulpotomy

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.

Intervention Type: PROCEDURE

Pulpectomy

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)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Healthy (ASA I and II) co-operative children (Frankl Scale + and ++) between the ages of four and nine years.

2. Participants have symptoms typical of irreversible pulpitis in one of the primary molars.

3. The pulp of the affected primary molar is vital.

4. Radicular pulp health is confirmed by attainment of radicular pulp haemostasis within 6 minutes of coronal pulp amputation.

5. The affected primary molars can be restored with full coverage stainless steel crowns.

6. Any physiologic root resorption, if present, is less than ⅓ the root length.

Exclusion Criteria

1. Clinical examination of affected primary molar reveals signs of pulpal infection (e.g. pathologic tooth mobility, parulis/fistula, or soft tissue swelling).

2. Pre-operative periapical radiograph suggests presence of periapical radiolucency or pathologic root resorption.

3. Visual examination of pulp tissue after deroofing reveals signs of necrosis (e.g. avascular/minimally bleeding pulp tissue or yellowish necrotic areas/purulent exudate).

4. Signs of extensive radicular pulp inflammation i.e., root pulp bleeding continues even after 6-min.

5. Parents not willing to place full coverage crowns post-treatment.

6. Clinical diagnosis of irreversible pulpitis between two adjacent primary molars is not sharply defined.

7. Unable to perform clinical procedure under rubber dam

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jordan University of Science and Technology

OTHER

Sponsor Role: collaborator

Primary Health Care Corporation, Qatar

OTHER_GOV

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: collaborator

Christian Dental College

UNKNOWN

Sponsor Role: collaborator

Oral and Dental Teaching Hospital, Libya

UNKNOWN

Sponsor Role: collaborator

Qatar University

OTHER

Sponsor Role: lead

Responsible Party

Nebu Philip

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nebu Philip, MDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Qatar University

Central Contacts

Nebu Philip, MDS, PhD

Role: CONTACT

nphilip@qu.edu.qa

+974-44037319

Hani Nazzal, PhD

Role: CONTACT

hnazzal@hamad.qa

+974-44037809

Other Identifiers

2025_RCT

Identifier Type: -

Identifier Source: org_study_id