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

NCT ID: NCT06183203

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2027-06-30

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 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.

Conditions

Irreversible Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pulpotomy

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

Group Type: EXPERIMENTAL

Pulpotomy

Intervention Type: 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.

Pulpectomy

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

Group Type: ACTIVE_COMPARATOR

Pulpectomy

Intervention Type: 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)

Interventions

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.

Intervention Type: 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)

Intervention Type: PROCEDURE

Other Intervention Names

Full Pulpotomy; Cervical Pulpotomy; Root canal treatment in primary teeth

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 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Christian Dental College

UNKNOWN

Sponsor Role: collaborator

Nebu Philip

OTHER

Sponsor Role: lead

Responsible Party

Nebu Philip

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bharat Suneja, MDS

Role: STUDY_DIRECTOR

The Dental Care Center

Nebu Philip, PhD

Role: PRINCIPAL_INVESTIGATOR

Qatar University

Locations

Christian Dental College

Ludhiana, Punjab, India

Countries

India

Central Contacts

Joe Cherian, MDS

Role: CONTACT

joe.cherian@cmcludhiana.in

+91-9501708436

Facility Contacts

Joe Cherian, MDS

Role: primary

joe.cherian@cmcludhiana.in

+91-9501708436

References

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.

Reference Type: DERIVED

PMID: 38807160 (View on PubMed)

Other Identifiers

BJS-CDC

Identifier Type: -

Identifier Source: org_study_id