Irreversible PulpitisNCT06149845
Pulpotomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis
A study testing Full Pulpotomy in people with Irreversible Pulpitis, run by Qatar University at 2 sites in Qatar.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Full Pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesQatar
- Study dates
- 21 Mar 2024to 31 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Treatment Outcomes of Pulpotomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis: An International Multi-centre Study
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.
Read the 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
- Being tested
- Full Pulpotomy
- Keywords
- Pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full PulpotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulpotomy | Experimental | Participants diagnosed with symptomatic irreversible pulpitis in vital primary molars will receive the pulpotomy treatment intervention Receives: Procedure: Full Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months, 12 months, 24 months
Secondary outcomes (2)
Immediate post-treatment pain relief
Pain scores that will be recorded at 24-hours and 7-days post-treatment using a child friendly Visual Analogue Scale (VAS). This pain score will be used to evaluate pain reduction afforded by the pulpotomy treatment intervention.
Measured: 24 hours; 7 days
Post-treatment radiographic success
Radiographic success will be determined at 6-, 12-, and 24-months based on the pulpotomy treated tooth meeting all the below criteria:
- No signs of pathological internal/external root resorption or new furcal/periapical lesions on recall periapical radiographs
- Complete radiographic healing or reduction/no change in size of any pre-treatment furcal rarefaction on recall periapical radiographs
Measured: 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start21 Mar 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal prospective single-arm cohort study
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qatar University
- Sponsor type
- University, hospital or other
- Collaborators
- Primary Health Care Corporation, Qatar, Jordan University of Science and Technology, King Abdulaziz Hospital, Saudi Arabia, Dubai Dental Hospital, Cairo University, Hamdan Bin Mohammed College of Dental Medicine
- Responsible party
- Principal investigator, Nebu Philip, Qatar University
- Investigators
- Nebu Philip, PhD, Principal investigator, Qatar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149845
- Sponsor's protocol ID
- QU2713
- Status last verified
- Aug 2026
- First submitted
- 18 Nov 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41027503