Pulpotomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis

NCT ID: NCT06149845

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-21
• Study Completion Date: 2027-07-31

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.

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 limited research on whether pulpotomy can be similarly used as a definitive treatment modality for vital primary teeth diagnosed with irreversible pulpitis.

Aim: This study primarily aims to assess the clinical and radiographic treatment outcomes of full pulpotomy in vital primary molars diagnosed with symptomatic irreversible pulpitis.

Methods/Design: Healthy cooperative children, between 4-9 years of age, who have painful primary molars with symptoms typical of irreversible pulpitis will be recruited for the study from paediatric dental clinics located in eight countries (Qatar, Saudi Arabia, Kuwait, U.A.E, Jordan, Egypt, U.S.A, and Thailand). The primary outcome that will be assessed are the clinical success rates after one-year and two-years of the pulpotomy intervention. The secondary outcomes that will be assessed include: (i) immediate post-operative pain relief after 24 h and 7-days of the pulpotomy intervention; and (ii) radiographic success rates after one-year and two-years of the pulpotomy intervention. 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 evaluated.

Discussion: This clinical trial seeks to provide evidence on whether pulpotomy can be used for the management of vital primary molars diagnosed with symptomatic irreversible pulpitis

Conditions

Irreversible Pulpitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• 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

Full Pulpotomy

Intervention Type: 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.

Interventions

Full Pulpotomy

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.

Intervention Type: PROCEDURE

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 6 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-pulpotomy.

7. Clinical diagnosis of irreversible pulpitis between two teeth is not sharply defined.

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

Sponsors

Primary Health Care Corporation, Qatar

OTHER_GOV

Sponsor Role: collaborator

Jordan University of Science and Technology

OTHER

Sponsor Role: collaborator

King Abdulaziz Hospital, Saudi Arabia

UNKNOWN

Sponsor Role: collaborator

Dubai Dental Hospital

UNKNOWN

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: collaborator

Hamdan Bin Mohammed College of Dental Medicine

UNKNOWN

Sponsor Role: collaborator

Qatar University

OTHER

Sponsor Role: lead

Responsible Party

Nebu Philip

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nebu Philip, PhD

Role: PRINCIPAL_INVESTIGATOR

Qatar University

Locations

Phcc - Airport Center

Doha, , Qatar

PHCC- Leebaib Center

Doha, , Qatar

Countries

Qatar

References

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 Sep 28:106140. doi: 10.1016/j.jdent.2025.106140. Online ahead of print.

Reference Type: DERIVED

PMID: 41027503 (View on PubMed)

Other Identifiers

QU2713

Identifier Type: -

Identifier Source: org_study_id