Pulpotomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis

NCT06149845 | Active Not Recruiting

• 1 other identifier: QU2713
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

This is a clinical trial to assess the treatment outcomes of pulpotomy in vital primary molars diagnosed with symptomatic irreversible pulpitis. Pulpotomy is a more conservative treatment option over the conventional pulpectomy treatment. Compared to pulpectomy, pulpotomy is a technically simpler procedure, less time consuming, easier for young patients to tolerate, and retains the proprioceptive sensation of the tooth - all important advantages when treating young children.

Conditions

Irreversible Pulpitis

Keywords

Pulpotomy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Immediate post-treatment pain relief

  24 hours; 7 days

• Post-treatment radiographic success

  6 months, 12 months, 24 months

Study Arms (1)

Pulpotomy

EXPERIMENTAL

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

Procedure: Full Pulpotomy

Interventions

Full Pulpotomy PROCEDURE

Pulpotomy is a more conservative pulp treatment option where only the coronal pulp is removed and a medicament placement over the remnant radicular pulp after haemostasis is achieved.

Pulpotomy

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 6 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-pulpotomy.
• Clinical diagnosis of irreversible pulpitis between two teeth is not sharply defined.

Sponsors & Collaborators

• Qatar University: lead
• Primary Health Care Corporation, Qatar: collaborator
• Jordan University of Science and Technology: collaborator
• King Abdulaziz Hospital, Saudi Arabia: collaborator
• Dubai Dental Hospital: collaborator
• Cairo University: collaborator
• Hamdan Bin Mohammed College of Dental Medicine: collaborator

Study Sites (2)

Phcc - Airport Center

Doha, Qatar

Location

PHCC- Leebaib Center

Doha, Qatar

Location

Related Publications (1)

• Philip N, Kowash M, Bani-Hani T, Shahawy OE, Issa A, Mohamed H, Abdalla M, Jundi S, Albadri S, Duggal M, Nazzal H. Pulpotomy for treating primary molars with clinical symptoms indicative of irreversible pulpitis: A prospective single-arm pilot study. J Dent. 2025 Dec;163:106140. doi: 10.1016/j.jdent.2025.106140. Epub 2025 Sep 28.

  PMID: 41027503 DERIVED

Study Officials

• Nebu Philip, PhD

  Qatar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Longitudinal prospective single-arm cohort study

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: November 29, 2023
• Study Start: March 21, 2024
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

QA (2)