Clinical trial NCT06904781: Treatment Outcomes of Pulpotomy Versus Pulpectomy in Vital Primary Molars Diagnosed With Irreversible Pulpitis
Official title: Treatment Outcomes of Pulpotomy Versus Pulpectomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis: A Non-inferiority Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Irreversible Pulpitis
Keywords: Pulpectomy
Pulpotomy
Vital primary molars
Irreversible pulpitis
Lead sponsor: Qatar University
Sponsor class: OTHER
Collaborators: name: Jordan University of Science and Technology
name: Primary Health Care Corporation, Qatar
name: Cairo University
name: Christian Dental College
name: Oral and Dental Teaching Hospital, Libya
First posted: 2025-04-01
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority randomised controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Post-treatment clinical outcomes based on presence/absence of pain, tenderness, or signs of infection/pathologic mobility
timeFrame: 6 months; 12 months; 24 months
Secondary outcomes:
measure: 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
timeFrame: 6 months; 12 months; 24 months
measure: Immediate post-treatment pain relief
timeFrame: 24 hours; 7 day
Other outcomes:
Locations:
Study officials:
affiliation: Qatar University
name: Nebu Philip, MDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: