Treatment Outcomes of Pulpotomy vs. Pulpectomy in Vital Primary Molars With Symptomatic Irreversible Pulpitis

Study Overview
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Brief Summary
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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
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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 very 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 for the study from two academic centres, after obtaining informed consent from their parents/legal guardians. 60 vital primary molars with symptomatic irreversible pulpitis will be randomly distributed between the two treatment groups. The primary outcomes that will be assessed are clinical and radiographic 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. Secondary outcomes that will be evaluated include post-operative pain relief and procedural time taken for the treatment 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.

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

Conditions
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Irreversible Pulpitis

Intervention / Treatment
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* Procedure: Pulpotomy
* Procedure: Pulpectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 8 minutes of coronal pulp amputation. The affected primary molars can be restored with full coverage crowns. Any physiologic root resorption, if present, is less than ⅓ the root length Exclusion Criteria: 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. Pre-operative periapical radiograph suggests presence of furcal radiolucency more than ½ the furcation to periapical area. 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. Parents not willing to place full coverage crowns post-treatment. Clinical diagnosis of irreversible pulpitis between two primary molars is not sharply defined

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-inferiority randomised controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulpotomy<br>Participants diagnosed with symptomatic irreversible pulpitis in vital primary molars will receive the pulpotomy treatment intervention. | Procedure: Pulpotomy<br>* 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.<br>* Other names: Cervical Pulpotomy;|
| Active Comparator: Pulpectomy<br>Participants diagnosed with symptomatic irreversible pulpitis in vital primary molars will receive the pulpectomy treatment intervention. | Procedure: Pulpectomy<br>* 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 (Endoflas)<br>* Other names: Root canal treatment in primary teeth;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-treatment clinical success | Clinical success will be determined at 6-, 12-, and 24-months based on the pulpotomy treated tooth meeting all the below criteria: Treated tooth is not associated with any pain or discomfort Treated tooth is not associated with tenderness on percussion or palpation Treated tooth is not associated with any swelling, parulis, or fistula Treated tooth is not associated with any pathological mobility | 6 months; 12 months; 24 months | 
| Post-treatment radiographic success | Radiographic success will be determined at 6-, 12-, and 24-months based on the pulpotomy treated tooth meeting all the below criteria: No signs of pathological internal/external root resorption or new furcal/periapical lesions on recall periapical radiographs Complete radiographic healing or reduction/no change in size of any pre-treatment furcal rarefaction on recall periapical radiographs | 6 months; 12 months; 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate post-treatment pain relief | Pain scores that will be recorded at 24-hours and 7-days post-treatment using a child friendly Visual Analogue Scale (VAS). This pain score will be used to evaluate pain reduction afforded by the pulpotomy treatment intervention. | 24 hours; 7 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulpectomy, Pulpotomy, Vital primary molars, Irreversible pulpitis