Irreversible PulpitisNCT06183203
Treatment Outcomes of Pulpotomy vs. Pulpectomy in Vital Primary Molars With Symptomatic Irreversible Pulpitis
A study testing Pulpotomy and Pulpectomy in people with Irreversible Pulpitis, run by Nebu Philip at 1 site in India.
Trial summary
This randomised controlled trial aims to compare treatment outcomes between pulpotomy and pulpectomy when used to treat vital primary molars diagnosed with symptomatic irreversible pulpitis. 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?
- Pulpotomy and Pulpectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- 15 Feb 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 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).
- Signs of extensive radicular pulp inflammation.
- Parents not willing to place full coverage crowns post-treatment.
- Clinical diagnosis of irreversible pulpitis between two primary molars is not sharply defined
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Outcomes of Pulpotomy Versus Pulpectomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis
This randomised controlled trial aims to compare treatment outcomes between pulpotomy and pulpectomy when used to treat vital primary molars diagnosed with symptomatic irreversible pulpitis. Compared to the standard pulpectomy treatment, pulpotomy is a technically simpler procedure, less time consuming, easier for young patients to tolerate, while retaining 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 very limited research on whether pulpotomy can be similarly used as a definitive treatment modality for vital primary teeth with irreversible pulpitis. This randomised controlled trial (RCT) aims to compare the treatment effectiveness of pulpotomy versus pulpectomy in management of vital primary molars diagnosed with symptomatic irreversible pulpitis over a two-year period.
Methods/Design: This clinical study is a parallel, two-armed, open label, non-inferiority RCT with a 1:1 allocation ratio between the experimental intervention arm (pulpotomy) and the active comparator arm (pulpectomy). Healthy cooperative children, between 4-9 years of age, who have painful primary molars with clinical symptoms typical of irreversible pulpitis will be recruited after obtaining informed consent from their parents/legal guardians. 50 vital primary molars clinically diagnosed with symptomatic irreversible pulpitis will be randomly distributed between the two treatment arms. The primary outcomes that will be assessed are clinical and radiographic success after one-year and two-years of the trial interventions. 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 assessed. The secondary outcome evaluated will be the immediate (24 h and 7 d) post-operative pain relief for the two treatment interventions.
Discussion: This trial seeks to provide evidence on whether pulpotomy treatment can be no worse than the standard pulpectomy treatment for the management of symptomatic irreversible pulpitis in vital primary molars.
- Conditions
- Irreversible Pulpitis
- Being tested
- Pulpotomy, Pulpectomy
- Keywords
- Pulpectomy, Pulpotomy, Vital primary molars, Irreversible pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpotomyProcedure or surgery
Also called Full Pulpotomy, Cervical Pulpotomy
Pulpotomy is a conservative pulp treatment option where only the coronal pulp is removed and a bioactive medicament (MTA) is placed over the remnant radicular pulp after haemostasis is achieved.
PulpectomyProcedure or surgery
Also called Root canal treatment in primary teeth
Pulpectomy is treatment procedure in primary teeth where the entire coronal and radicular pulp is extirpated and the root canal system filled with a resorbable material (Endoflas)
| 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: Pulpotomy |
| Pulpectomy | Active comparator | Participants diagnosed with symptomatic irreversible pulpitis in vital primary molars will receive the pulpectomy treatment intervention. Receives: Procedure: Pulpectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcome
Clinical outcome success will be determined at 6-, 12-, and 24-months based on the 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
Radiographic Outcome
Radiographic outcome 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
Secondary outcomes (1)
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). The VAS has five-point pain score: 0-No Pain; 1-Mild Pain; 2-Moderate Pain; 3-Severe Pain; and 4-Very Severe Pain.
This VAS pain score will be used to evaluate pain reduction afforded by the treatment intervention.
Measured: 24 hours; 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start15 Feb 2024 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Why it stopped: Trials sites withdrew from the study as patient recruitment was not possible
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-inferiority randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nebu Philip
- Sponsor type
- University, hospital or other
- Collaborators
- Christian Dental College
- Responsible party
- Sponsor-investigator, Nebu Philip, Qatar University
- Investigators
- Bharat Suneja, MDS, Study director, The Dental Care CenterNebu Philip, PhD, Principal investigator, Qatar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183203
- Sponsor's protocol ID
- BJS-CDC
- Status last verified
- Aug 2026
- First submitted
- 13 Dec 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Philip N, Cherian JM, Mathew MG, Thomas AM, Jodhka S, John N, Suneja B, Duggal M. Treatment outcomes of pulpotomy versus pulpectomy in vital primary molars diagnosed with symptomatic irreversible pulpitis: protocol for a non-inferiority randomised controlled trial. BMC Oral Health. 2024 May 28;24(1):626. doi: 10.1186/s12903-024-04411-6.
PubMed 38807160
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 Versus Pulpectomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT06183203
- Acronym / sponsor ID
- BJS-CDC
- Conditions
- Irreversible Pulpitis
- Keywords
- Pulpectomy, Pulpotomy, Vital primary molars, Irreversible pulpitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trials sites withdrew from the study as patient recruitment was not possible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nebu PhilipUniversity, hospital or other
- Collaborators
- Christian Dental College
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 Dec 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 randomised controlled trial aims to compare treatment outcomes between pulpotomy and pulpectomy when used to treat vital primary molars diagnosed with symptomatic irreversible pulpitis. Compared to the standard pulpectomy treatment, pulpotomy is a technically simpler procedure, less time consuming, easier for young patients to tolerate, while retaining 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 very limited research on whether pulpotomy can be similarly used as a definitive treatment modality for vital primary teeth with irreversible pulpitis. This randomised controlled trial (RCT) aims to compare the treatment effectiveness of pulpotomy versus pulpectomy in management of vital primary molars diagnosed with symptomatic irreversible pulpitis over a two-year period.
Methods/Design: This clinical study is a parallel, two-armed, open label, non-inferiority RCT with a 1:1 allocation ratio between the experimental intervention arm (pulpotomy) and the active comparator arm (pulpectomy). Healthy cooperative children, between 4-9 years of age, who have painful primary molars with clinical symptoms typical of irreversible pulpitis will be recruited after obtaining informed consent from their parents/legal guardians. 50 vital primary molars clinically diagnosed with symptomatic irreversible pulpitis will be randomly distributed between the two treatment arms. The primary outcomes that will be assessed are clinical and radiographic success after one-year and two-years of the trial interventions. 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 assessed. The secondary outcome evaluated will be the immediate (24 h and 7 d) post-operative pain relief for the two treatment interventions.
Discussion: This trial seeks to provide evidence on whether pulpotomy treatment can be no worse than the standard pulpectomy treatment for the management of symptomatic irreversible pulpitis in vital primary molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-inferiority randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Pulpotomy | Experimental | Procedure: PulpotomyParticipants diagnosed with symptomatic irreversible pulpitis in vital primary molars will receive the pulpotomy treatment intervention. |
| Pulpectomy | Active comparator | Procedure: PulpectomyParticipants diagnosed with symptomatic irreversible pulpitis in vital primary molars will receive the pulpectomy 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 8 minutes of coronal pulp amputation.
- The affected primary molars can be restored with full coverage crowns.
Key exclusion criteria (8 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. avascular/minimally bleeding pulp tissue or yellowish necrotic areas/purulent exudate).
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 |
|---|---|---|
| PulpotomyAlso: Full Pulpotomy, Cervical PulpotomyPulpotomy is a conservative pulp treatment option where only the coronal pulp is removed and a bioactive medicament (MTA) is placed over the remnant radicular pulp after haemostasis is achieved. | Procedure or surgery | Pulpotomy |
| PulpectomyAlso: Root canal treatment in primary teethPulpectomy is treatment procedure in primary teeth where the entire coronal and radicular pulp is extirpated and the root canal system filled with a resorbable material (Endoflas) | Procedure or surgery | Pulpectomy |
Primary outcome
Clinical Outcome
Time frame: 6 months; 12 months; 24 months
Clinical outcome success will be determined at 6-, 12-, and 24-months based on the 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
Radiographic Outcome
Time frame: 6 months; 12 months; 24 months
Radiographic outcome 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
1 secondary outcome
Immediate post-treatment pain relief
Time frame: 24 hours; 7 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Derived from this study: PubMed 38807160Philip N, Cherian JM, Mathew MG, Thomas AM, Jodhka S, John N, Suneja B, Duggal M. Treatment outcomes of pulpotomy versus pulpectomy in vital primary molars diagnosed with symptomatic irreversible pulpitis: protocol for a non-inferiority randomised controlled trial. BMC Oral Health. 2024 May 28;24(1):626. doi: 10.1186/s12903-024-04411-6.
- 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.
Bharat Suneja, MDS study director
The Dental Care Center
Nebu Philip, PhD principal investigator
Qatar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulpotomy and Pulpectomy in people with Irreversible Pulpitis, run by Nebu Philip at 1 site in India.
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 8 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: withdrawn, 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 1 site in India. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Clinical Outcome (time frame: 6 months; 12 months; 24 months). The study lists 2 primary outcomes in all. 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 NCT06183203, 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.