Pulpotomy treatment for painful primary molars in children
Treatment Outcomes of Pulpotomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis: An International Multi-centre Study
This study is testing if a less invasive tooth treatment called pulpotomy can help relieve pain and save primary molars in children aged 4 to 9 with serious tooth issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 4 Years to 9 Years |
| Sex | All |
| Sponsor | Qatar University Academic / other |
| Locations | 2 sites (Doha and 1 other locations) |
| Trial ID | NCT06149845 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of pulpotomy as a treatment for vital primary molars diagnosed with symptomatic irreversible pulpitis in children aged 4 to 9 years. Pulpotomy is a less invasive alternative to the traditional pulpectomy, aiming to preserve the tooth while alleviating pain. The study will assess clinical and radiographic outcomes over one and two years, focusing on success rates and post-operative pain relief. Participants will be recruited from pediatric dental clinics across eight countries, ensuring a diverse patient population.
Who should consider this trial
Good fit: Ideal candidates are healthy children aged 4 to 9 years with vital primary molars showing symptoms of irreversible pulpitis.
Not a fit: Patients with signs of pulpal infection or significant periapical radiolucency will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive and more effective option for managing painful primary molars in children.
How similar studies have performed: While pulpotomy has been successfully used in permanent teeth, this approach for primary teeth is relatively novel and has limited prior research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Doha and 1 other locations
- Phcc - Airport Center — Doha, Qatar (Recruiting)
- PHCC- Leebaib Center — Doha, Qatar (Recruiting)
Study contacts
- Principal investigator: Nebu Philip, PhD — Qatar University
- Study coordinator: Nebu Philip, PhD
- Email: nphilip@qu.edu.qa
- Phone: +974-44037319
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.