Clinical trial NCT06149845: Pulpotomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis
Official title: Treatment Outcomes of Pulpotomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis: An International Multi-centre Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irreversible Pulpitis
Keywords: Pulpotomy
Lead sponsor: Qatar University
Sponsor class: OTHER
Collaborators: name: Primary Health Care Corporation, Qatar
name: Ministry of Health, Kuwait
name: Jordan University of Science and Technology
name: King Abdulaziz Hospital, Saudi Arabia
name: Dubai Dental Hospital
name: Cairo University
name: Mahidol University
name: NYU Langone Health
name: Hamdan Bin Mohammed College of Dental Medicine
name: Sun Life Health, Arizona
First posted: 2023-11-29
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal prospective single-arm cohort study
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Post-treatment clinical success
timeFrame: 6 months, 12 months, 24 months
Secondary outcomes:
measure: Immediate post-treatment pain relief
timeFrame: 24 hours; 7 days
measure: Post-treatment radiographic success
timeFrame: 6 months, 12 months, 24 months
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Phcc - Airport Center
city: Doha
country: Qatar
facility: PHCC- Leebaib Center
Study officials:
affiliation: Qatar University
name: Nebu Philip, PhD
role: PRINCIPAL_INVESTIGATOR
References: