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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Irreversible Pulpitis
• Intervention / Treatment: Procedure: Pulpotomy; Procedure: Pulpectomy

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 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 after obtaining informed consent from their parents/legal guardians. 50 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 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. The secondary outcome evaluated will be the immediate (24 h and 7 d) post-operative pain relief for the two 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joe Cherian, MDS; Phone Number: +91-9501708436; Email: joe.cherian@cmcludhiana.in

Study Locations

• India
  • Punjab
    • Ludhiāna, Punjab, India, 141008
      • Christian Dental College
      • Contact: Joe Cherian, MDS; Phone Number: +91-9501708436; Email: joe.cherian@cmcludhiana.in

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 8 minutes of coronal pulp amputation.
5. The affected primary molars can be restored with full coverage 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.
3. Pre-operative periapical radiograph suggests presence of furcal radiolucency more than ½ the furcation to periapical area.
4. Visual examination of pulp tissue after deroofing reveals signs of necrosis (e.g. avascular/minimally bleeding pulp tissue or yellowish necrotic areas/purulent exudate).
5. Signs of extensive radicular pulp inflammation.
6. Parents not willing to place full coverage crowns post-treatment.
7. Clinical diagnosis of irreversible pulpitis between two primary molars is not sharply defined

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcome	Clinical outcome success will be determined at 6-, 12-, and 24-months based on the 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
Radiographic Outcome	Radiographic outcome 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). The VAS has five-point pain score: 0-No Pain; 1-Mild Pain; 2-Moderate Pain; 3-Severe Pain; and 4-Very Severe Pain. This VAS pain score will be used to evaluate pain reduction afforded by the treatment intervention.	24 hours; 7 day

Collaborators and Investigators

• Sponsor: Nebu Philip
• Collaborators: Christian Dental College
• Investigators: Principal Investigator: Nebu Philip, PhD, Qatar University; Study Director: Bharat Suneja, MDS, The Dental Care Center

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 27, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Irreversible pulpitis; Pulpectomy; Pulpotomy; Vital primary molars
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis
• Other Study ID Numbers: BJS-CDC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No