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

NCT06183203 | Not Yet Recruiting DMC

• 1 other identifier: BJS-CDC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Irreversible Pulpitis

Keywords

Pulpectomy; Pulpotomy; Vital primary molars; Irreversible pulpitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Immediate post-treatment pain relief

  24 hours; 7 day

Study Arms (2)

Pulpotomy

EXPERIMENTAL

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

Procedure: Pulpotomy

Pulpectomy

ACTIVE COMPARATOR

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

Procedure: Pulpectomy

Interventions

Pulpotomy 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.

Also known as: Full Pulpotomy, Cervical Pulpotomy

Pulpotomy

Pulpectomy 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 (Endoflas)

Also known as: Root canal treatment in primary teeth

Pulpectomy

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nebu Philip: lead
• Christian Dental College: collaborator

Study Sites (1)

Christian Dental College

Ludhiana, Punjab, 141008, India

Location

Related Publications (1)

• Philip N, Cherian JM, Mathew MG, Thomas AM, Jodhka S, John N, Suneja B, Duggal M. Treatment outcomes of pulpotomy versus pulpectomy in vital primary molars diagnosed with symptomatic irreversible pulpitis: protocol for a non-inferiority randomised controlled trial. BMC Oral Health. 2024 May 28;24(1):626. doi: 10.1186/s12903-024-04411-6.

  PMID: 38807160 DERIVED

MeSH Terms

Interventions

Pulpotomy; Pulpectomy

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• Bharat Suneja, MDS

  The Dental Care Center

  STUDY DIRECTOR

• Nebu Philip, PhD

  Qatar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joe Cherian, MDS

CONTACT

+91-9501708436; joe.cherian@cmcludhiana.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Non-inferiority randomised controlled trial

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 27, 2023
• Study Start: February 15, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)