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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcomes of Pulpotomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis: An International Multi-centre Study
- ClinicalTrials.gov ID
- NCT06149845
- Acronym / sponsor ID
- QU2713
- Conditions
- Irreversible Pulpitis
- Keywords
- Pulpotomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Qatar UniversityUniversity, 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
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal prospective single-arm cohort study
| Arm | Type | Receives |
|---|---|---|
| Pulpotomy | Experimental | Procedure: Full PulpotomyParticipants diagnosed with symptomatic irreversible pulpitis in vital primary molars will receive the pulpotomy treatment intervention |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full PulpotomyPulpotomy 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. | Procedure or surgery | Pulpotomy |
Primary outcome
Post-treatment clinical success
Time frame: 6 months, 12 months, 24 months
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
2 secondary outcomes
Immediate post-treatment pain relief
Time frame: 24 hours; 7 days
Post-treatment radiographic success
Time frame: 6 months, 12 months, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Derived from this study: PubMed 41027503Philip 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nebu Philip, PhD principal investigator
Qatar University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full Pulpotomy in people with Irreversible Pulpitis, run by Qatar University at 2 sites in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-treatment clinical success (time frame: 6 months, 12 months, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06149845, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.