NCT06149845

Pulpotomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis

Treatment Outcomes of Pulpotomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis: An International Multi-centre Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Qatar University · Academic / Other
• Sex: All
• Age: 4 Years – 9 Years
• Healthy volunteers: Accepted

Summary

This is a clinical trial to assess the treatment outcomes of pulpotomy in vital primary molars diagnosed with symptomatic irreversible pulpitis. Pulpotomy is a more conservative treatment option over the conventional pulpectomy treatment. Compared to pulpectomy, pulpotomy is a technically simpler procedure, less time consuming, easier for young patients to tolerate, and retains 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 diagnosed with irreversible pulpitis. Aim: This study primarily aims to assess the clinical and radiographic treatment outcomes of full pulpotomy in vital primary molars diagnosed with symptomatic irreversible pulpitis. Methods/Design: Healthy cooperative children, between 4-9 years of age, who have painful primary molars with symptoms typical of irreversible pulpitis will be recruited for the study from paediatric dental clinics located in eight countries (Qatar, Saudi Arabia, Kuwait, U.A.E, Jordan, Egypt, U.S.A, and Thailand). The primary outcome that will be assessed are the clinical success rates after one-year and two-years of the pulpotomy intervention. The secondary outcomes that will be assessed include: (i) immediate post-operative pain relief after 24 h and 7-days of the pulpotomy intervention; and (ii) radiographic success rates after one-year and two-years of the pulpotomy intervention. 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 evaluated. Discussion: This clinical trial seeks to provide evidence on whether pulpotomy can be used for the management of vital primary molars diagnosed with symptomatic irreversible pulpitis

Conditions

• Irreversible Pulpitis

Interventions

Type	Name	Description
PROCEDURE	Full Pulpotomy	Pulpotomy is a more conservative pulp treatment option where only the coronal pulp is removed and a medicament placement over the remnant radicular pulp after haemostasis is achieved.

Timeline

• Start date: 2024-03-21
• Primary completion: 2027-07-30
• Completion: 2027-07-31
• First posted: 2023-11-29
• Last updated: 2025-07-31

Locations

2 sites across 1 country: Qatar