Pulpitis - IrreversibleNCT06002698
Full Pulpotomy Versus Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis
A study testing Full pulpotomy (Experimental) in people with Pulpitis - Irreversible, run by University of Malaya at 1 site in Malaysia.
Trial summary
Background The European Society of Endodontology (ESE) and the American Association of Endodontists (AAE) position statements on the management of deep caries and exposed pulp recommended adoption and promotion of strategies aimed at preserving the pulp, but also acknowledged the need for well-designed and adequately… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Full pulpotomy (Experimental)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 8 Aug 2023to 31 Mar 2025
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients aged 12 years or older (with a mature permanent tooth demonstrating radiographic evidence of a deep caries/restorations and signs/ symptoms indicative of IRP (moderate to severe spontaneous lingering pain). Tooth will be responsive to cold and EPT sensibility testing, restorable and can be adequately isolated during treatment. One posterior tooth (molar or premolar) only per patient.
Who cannot join
- Teeth with active periodontal disease (pocket depth >5mm); teeth indicated for elective root canal treatment for restorative purposes, teeth with apical periodontitis, patients with complex medical histories that may affect their caries experience and healing ability (immunocompromised, radiotherapy), patients who are unable to consent; history of previous trauma to the tooth, presence of apical radiolucency and patients who are pregnant or breast-feeding. Intraoperatively, any evidence of purulence or excessive bleeding that cannot be controlled with a cotton pellet with 2-4% hypochlorite for 10 minutes will be excluded.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Hany Mohamed Aly Ahmed
Kuala Lumpur, 50603
Hany MA Ahmed, 0060129857937, hanyendodontist@um.edu.my
Foo K Room
About this study
Official title: Full Pulpotomy Versus Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis: A Clinical Study
Background The European Society of Endodontology (ESE) and the American Association of Endodontists (AAE) position statements on the management of deep caries and exposed pulp recommended adoption and promotion of strategies aimed at preserving the pulp, but also acknowledged the need for well-designed and adequately powered randomised control trials to provide the evidence needed to support vital pulp treatment (VPT) and change clinical practice.
Objectives
- To undertake a randomised controlled clinical trial comparing full pulpotomy with root canal treatment for mature maxillary and mandibular posterior teeth with signs and symptoms indicative of irreversible pulpitis and normal apical tissues in adults.
- Undertake a cost-effectiveness analysis to examine the potential long-term costs and benefits of pulpotomy.
- Undertake a process evaluation to assess the acceptability of the intervention to both dentists and patients, while exploring the barriers and enablers to implementation.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Root canal treatment (Control), Full pulpotomy (Experimental)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal treatment (Control)Procedure or surgery
Root canal treatment - Removal of the inflamed pulp tissues from the whole root canals of the tooth.
Full pulpotomy (Experimental)Procedure or surgery
Full pulpotomy - Removal of the inflamed coronal pulp tissues from the crown of the tooth.
| Study group | Role | What they receive |
|---|---|---|
| Root canal treatment (Control) | Other | The procedure can be carried out in single or two visits. Variations in root canal treatment protocols however will make it difficult to compare with pulpotomy so the aim is to standardize the protocols for the following variables including use of rubber dam, Irrigation protocol with 2-2.5% sodium hypochlorite; working length with combined radiographs and apex locators, automated instrumentation to accompany hand instrumentation and preparation to apical size 2-3 larger than the initial binding file. Canal to be medicated with non-setting calcium hydroxide if done in two visits and root canal filling with gutta percha and traditional sealers (warm or cold lateral condensation) and good coronal seal. Receives: Procedure: Root canal treatment (Control) |
| Full pulpotomy | Experimental | The clinical procedure will be completed over one or two visits. Following adequate anesthesia and isolation with rubber dam, access to the pulp will be gained following caries removal to de-roof the pulp chamber and excision of the entire coronal pulp. The pulp chamber is irrigated with 2% sodium hypochlorite solution and the resultant bleeding from the remaining pulp will be controlled with a cotton pellet soaked in 2% sodium hypochlorite solution. Following complete haemostasis, the pulp stump will then be covered with Biodentine (Septodont Ltd., Saint Maur des Fausse ́s, France) and the tooth permanently restored with a restoration if treatment is completed in single visit or temporized with glass ionomer cement for the final restoration to be placed in the 2nd visit if operator opted for 2-visit treatment. Receives: Procedure: Full pulpotomy (Experimental) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Data
(1) Clinical data: absence of pain, tenderness to palpation, presence of swelling, presence of sinus tract, pathological mobility, response to sensibility testing. Patient history taking and clinical examination for symptoms and clinical signs of infection such as swelling, and sinus tract will be performed by a blinded dental practitioner.
Measured: 6 months, 1 year and 2 years
Radiographic data
(2) Radiographic data: presence of periapical radiolucency, presence of inter-radicular radiolucency, presence of resorption, presence of calcifications. An independent assessor will assess the radiograph obtained at the 12-month review visit.
Measured: 6 months, 1 year and 2 years
Secondary outcomes (4)
Post-operative pain
(1) Postoperative pain will be recorded by patients on day 3 and 7. Pain will be assessed using a numeric rating scale (NRS). NRS is an 11-point numeric scale with 0 representing "no pain" and 10 representing "pain as bad as you can imagine". Patients will be instructed on how to use the NRS-11 at home on days 3 and 7 after the procedure. Patients will be contacted by phone call or text message to collect their responses.
Measured: Day 3 and Day 7
Structural integrity assessment
(2) Structural integrity of the tooth will be assessed by a blinded dental practitioner at the 12-month visit using World Dental Federation (FDI) criteria
Measured: 6 months, 1 year and 2 years
Evidence of further interventions and adverse effects
Evidence of further interventions and adverse events will be obtained from patient records following the 12-month review visit.
Measured: 6 months, 1 year and 2 years
Data for cost effective analysis
Data for cost effective analysis and process evaluation will be collected.
Measured: Baseline, 6 months, 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start8 Aug 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulpitis - IrreversibleStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc. Prof. Dr. Hany Mohamed Aly Ahmed, University of Malaya
- Investigators
- Hany Ahmed, PhD, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002698
- Sponsor's protocol ID
- DF RD2309/0068 (L)
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the IPD.
Publications
European Society of Endodontology (ESE) developed by:; Duncan HF, Galler KM, Tomson PL, Simon S, El-Karim I, Kundzina R, Krastl G, Dammaschke T, Fransson H, Markvart M, Zehnder M, Bjorndal L. European Society of Endodontology position statement: Management of deep caries and the exposed pulp. Int Endod J. 2019 Jul;52(7):923-934. doi: 10.1111/iej.13080.
PubMed 30664240AAE Position Statement on Vital Pulp Therapy. J Endod. 2021 Sep;47(9):1340-1344. doi: 10.1016/j.joen.2021.07.015. Epub 2021 Aug 3. No abstract available.
PubMed 34352305Taha NA, Abuzaid AM, Khader YS. A Randomized Controlled Clinical Trial of Pulpotomy versus Root Canal Therapy in Mature Teeth with Irreversible Pulpitis: Outcome, Quality of Life, and Patients' Satisfaction. J Endod. 2023 Jun;49(6):624-631.e2. doi: 10.1016/j.joen.2023.04.001. Epub 2023 Apr 19.
PubMed 37080387
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full Pulpotomy Versus Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis: A Clinical Study
- ClinicalTrials.gov ID
- NCT06002698
- Acronym / sponsor ID
- DF RD2309/0068 (L)
- Conditions
- Pulpitis - Irreversible
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 21 Aug 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.
Background The European Society of Endodontology (ESE) and the American Association of Endodontists (AAE) position statements on the management of deep caries and exposed pulp recommended adoption and promotion of strategies aimed at preserving the pulp, but also acknowledged the need for well-designed and adequately powered randomised control trials to provide the evidence needed to support vital pulp treatment (VPT) and change clinical practice.
Objectives
- To undertake a randomised controlled clinical trial comparing full pulpotomy with root canal treatment for mature maxillary and mandibular posterior teeth with signs and symptoms indicative of irreversible pulpitis and normal apical tissues in adults.
- Undertake a cost-effectiveness analysis to examine the potential long-term costs and benefits of pulpotomy.
- Undertake a process evaluation to assess the acceptability of the intervention to both dentists and patients, while exploring the barriers and enablers to implementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Root canal treatment (Control) | Other | Procedure: Root canal treatment (Control)The procedure can be carried out in single or two visits. Variations in root canal treatment protocols however will make it difficult to compare with pulpotomy so the aim is to standardize the protocols for the following variables including use of rubber dam, Irrigation protocol with 2-2.5% sodium hypochlorite; working length with combined radiographs and apex locators, automated instrumentation to accompany hand instrumentation and preparation to apical size 2-3 larger than the initial binding file. Canal to be medicated with non-setting calcium hydroxide if done in two visits and root canal filling with gutta percha and traditional sealers (warm or cold lateral condensation) and good coronal seal. |
| Full pulpotomy | Experimental | Procedure: Full pulpotomy (Experimental)The clinical procedure will be completed over one or two visits. Following adequate anesthesia and isolation with rubber dam, access to the pulp will be gained following caries removal to de-roof the pulp chamber and excision of the entire coronal pulp. The pulp chamber is irrigated with 2% sodium hypochlorite solution and the resultant bleeding from the remaining pulp will be controlled with a cotton pellet soaked in 2% sodium hypochlorite solution. Following complete haemostasis, the pulp stump will then be covered with Biodentine (Septodont Ltd., Saint Maur des Fausse ́s, France) and the tooth permanently restored with a restoration if treatment is completed in single visit or temporized with glass ionomer cement for the final restoration to be placed in the 2nd visit if operator opted for 2-visit treatment. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 12 years or older (with a mature permanent tooth demonstrating radiographic evidence of a deep caries/restorations and signs/ symptoms indicative of IRP (moderate to severe spontaneous lingering pain). Tooth will be responsive to cold and EPT sensibility testing, restorable and can be adequately isolated during treatment. One posterior tooth (molar or premolar) only per patient.
Key exclusion criteria (1 listed)
- Teeth with active periodontal disease (pocket depth >5mm); teeth indicated for elective root canal treatment for restorative purposes, teeth with apical periodontitis, patients with complex medical histories that may affect their caries experience and healing ability (immunocompromised, radiotherapy), patients who are unable to consent; history of previous trauma to the tooth, presence of apical radiolucency and patients who are pregnant or breast-feeding. Intraoperatively, any evidence of purulence or excessive bleeding that cannot be controlled with a cotton pellet with 2-4% hypochlorite for 10 minutes will be excluded.
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 |
|---|---|---|
| Root canal treatment (Control)Root canal treatment - Removal of the inflamed pulp tissues from the whole root canals of the tooth. | Procedure or surgery | Root canal treatment (Control) |
| Full pulpotomy (Experimental)Full pulpotomy - Removal of the inflamed coronal pulp tissues from the crown of the tooth. | Procedure or surgery | Full pulpotomy |
Primary outcome
Clinical Data
Time frame: 6 months, 1 year and 2 years
(1) Clinical data: absence of pain, tenderness to palpation, presence of swelling, presence of sinus tract, pathological mobility, response to sensibility testing. Patient history taking and clinical examination for symptoms and clinical signs of infection such as swelling, and sinus tract will be performed by a blinded dental practitioner.
Radiographic data
Time frame: 6 months, 1 year and 2 years
(2) Radiographic data: presence of periapical radiolucency, presence of inter-radicular radiolucency, presence of resorption, presence of calcifications. An independent assessor will assess the radiograph obtained at the 12-month review visit.
4 secondary outcomes
Post-operative pain
Time frame: Day 3 and Day 7
Structural integrity assessment
Time frame: 6 months, 1 year and 2 years
Evidence of further interventions and adverse effects
Time frame: 6 months, 1 year and 2 years
Data for cost effective analysis
Time frame: Baseline, 6 months, 1 year and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Background: PubMed 30664240European Society of Endodontology (ESE) developed by:; Duncan HF, Galler KM, Tomson PL, Simon S, El-Karim I, Kundzina R, Krastl G, Dammaschke T, Fransson H, Markvart M, Zehnder M, Bjorndal L. European Society of Endodontology position statement: Management of deep caries and the exposed pulp. Int Endod J. 2019 Jul;52(7):923-934. doi: 10.1111/iej.13080.
- Background: PubMed 34352305AAE Position Statement on Vital Pulp Therapy. J Endod. 2021 Sep;47(9):1340-1344. doi: 10.1016/j.joen.2021.07.015. Epub 2021 Aug 3. No abstract available.
- Background: PubMed 37080387Taha NA, Abuzaid AM, Khader YS. A Randomized Controlled Clinical Trial of Pulpotomy versus Root Canal Therapy in Mature Teeth with Irreversible Pulpitis: Outcome, Quality of Life, and Patients' Satisfaction. J Endod. 2023 Jun;49(6):624-631.e2. doi: 10.1016/j.joen.2023.04.001. Epub 2023 Apr 19.
- Individual participant dataSharing planned: No. There is no plan to share the IPD.
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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.
Hany Ahmed, PhD principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full pulpotomy (Experimental) in people with Pulpitis - Irreversible, run by University of Malaya at 1 site in Malaysia.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Aug 2023. 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 Malaysia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hany Ahmed, PhD (0060129857937, hanyendodontist@um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Data (time frame: 6 months, 1 year and 2 years). 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 NCT06002698, which also lists 3 linked publications.
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 21 Aug 2023.