Irreversible PulpitisPhase 4NCT06488131
Comparing MTA Pulpotomy to Root Canal Treatment in Management of Permanent Molars With Irreversible Pulpitis in Children
A Phase 4 study testing MTA Pulpotomy and Root Canal Treatment in people with Irreversible Pulpitis, run by Ain Shams University.
Trial summary
Dental caries, highly prevalent amongst children, can cause pulpitis. Coronal pulpotomy provides an easier, cost-effective, conservative and biologically-driven treatment option compared to endodontic treatment in mature permanent teeth with irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- MTA Pulpotomy and Root Canal Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jun 2025
- Phase
- Phase 4
- 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy male and female children, aged 10 to 14 years
- Signs and symptoms of irreversible pulpitis in carious first permanent molar.
Who cannot join
- Molars with immature roots
- Non-restorable molars, with abnormal mobility or increased probing pocket depth (normal range = 1-3 mm)
- Any indication of pulpal necrosis, such as sinus tract or swelling or no bleeding from orifices after access opening.
- Any signs of periapical or furcal rarefaction.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Comparative Study Between MTA Pulpotomy and Root Canal Treatment in Management of First Permanent Molars With Irreversible Pulpitis in Children: A Randomized Controlled Trial
Dental caries, highly prevalent amongst children, can cause pulpitis. Coronal pulpotomy provides an easier, cost-effective, conservative and biologically-driven treatment option compared to endodontic treatment in mature permanent teeth with irreversible pulpitis.
The aim of the current study is to evaluate postoperative pain, clinical and radiographic outcomes of MTA pulpotomy compared to root canal treatment in children's first permanent molars suffering from irreversible pulpitis.
Read the detailed description
In this randomized controlled trial, patients aged 10-14 years suffering from irreversible pulpitis in the first permanent molar with closed apex will be randomly divided into two groups. The first group will receive complete coronal MTA pulpotomy, while the second group will receive endodontic treatment.
- Conditions
- Irreversible Pulpitis
- Being tested
- MTA Pulpotomy, Root Canal Treatment
- Keywords
- Endodontic Treatment, Vital Pulp Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTA PulpotomyProcedure or surgery
Also called Vital Pulp Therapy
Complete coronal MTA pulpotomy.
Root Canal TreatmentProcedure or surgery
Also called Endodontic Treatment
Conventional root canal treatment.
| Study group | Role | What they receive |
|---|---|---|
| MTA Pulpotomy | Experimental | Local anesthesia for pain control will be administered, followed by rubber dam isolation. Then, the tooth and surrounding rubber dam will be flushed with chlorhexidine solution for disinfection. After caries removal, a sterile bur will be used for access opening and complete deroofing of the pulp chamber. Coronal pulp tissue will be removed to the level of canal orifices using a sterile, sharp spoon excavator. A cotton pellet dampened with sodium hypochlorite will be applied on canal orifices to achieve hemostasis. This will be followed by MTA application and glass ionomer restoration. If necessary, the tooth will be restored with stainless steel crown after one week. Receives: Procedure: MTA Pulpotomy |
| Root Canal Treatment | Active comparator | Local anesthesia for pain control will be administered, followed by rubber dam isolation. Then, the tooth and surrounding rubber dam will be flushed with chlorhexidine solution for disinfection. After caries removal, a sterile bur will be used for access opening and complete deroofing of the pulp chamber. Length of the root canal will be obtained using an apex locator. This will be followed by mechanical shaping using files, and irrigation with 2.5 percent sodium hypochlorite, followed by drying of the canals using paper points. Obturation will then be accomplished using gutta percha and sealer. Finally, the tooth will be restored with conventional glass ionomer restoration. If necessary, the tooth will be restored with stainless steel crown after one week. Receives: Procedure: Root Canal Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Relief
A 10 cm visual analogue scale will be used to record pain
Measured: preoperatively, immediately postoperatively and every 24 hours for 7 days after the first appointment.
Secondary outcomes (2)
Clinical Evaluation
- Absence of pain or discomfort
- Tooth is functional, with no tenderness to palpation or percussion
- Normal mobility and probing depth
- Soft tissues surrounding the tooth are normal, with no swelling or inflammation
Measured: 3, 6, 12 and 18 months postoperatively
Radiographic Evaluation
- No evident radiographic periapical or furcal pathosis
- No evident root resorption
- Normal lamina dura
Measured: 6, 12 and 18 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Eissa, Ain Shams University
- Investigators
- Alaa A. Eissa, Msc, Principal investigator, Faculty of Dentistry, Ain Shams University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488131
- Sponsor's protocol ID
- PED2024-D2
- Status last verified
- Jun 2024
- First submitted
- 28 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Publications
Galani M, Tewari S, Sangwan P, Mittal S, Kumar V, Duhan J. Comparative Evaluation of Postoperative Pain and Success Rate after Pulpotomy and Root Canal Treatment in Cariously Exposed Mature Permanent Molars: A Randomized Controlled Trial. J Endod. 2017 Dec;43(12):1953-1962. doi: 10.1016/j.joen.2017.08.007. Epub 2017 Oct 20.
PubMed 29061359Taha 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 37080387Asgary S, Eghbal MJ, Shahravan A, Saberi E, Baghban AA, Parhizkar A. Outcomes of root canal therapy or full pulpotomy using two endodontic biomaterials in mature permanent teeth: a randomized controlled trial. Clin Oral Investig. 2022 Mar;26(3):3287-3297. doi: 10.1007/s00784-021-04310-y. Epub 2021 Dec 2.
PubMed 34854987Beauquis J, Setbon HM, Dassargues C, Carsin P, Aryanpour S, Van Nieuwenhuysen JP, Leprince JG. Short-Term Pain Evolution and Treatment Success of Pulpotomy as Irreversible Pulpitis Permanent Treatment: A Non-Randomized Clinical Study. J Clin Med. 2022 Jan 31;11(3):787. doi: 10.3390/jcm11030787.
PubMed 35160239
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between MTA Pulpotomy and Root Canal Treatment in Management of First Permanent Molars With Irreversible Pulpitis in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06488131
- Acronym / sponsor ID
- PED2024-D2
- Conditions
- Irreversible Pulpitis
- Keywords
- Endodontic Treatment, Vital Pulp Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 5 Jul 2024 (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.
Dental caries, highly prevalent amongst children, can cause pulpitis. Coronal pulpotomy provides an easier, cost-effective, conservative and biologically-driven treatment option compared to endodontic treatment in mature permanent teeth with irreversible pulpitis.
The aim of the current study is to evaluate postoperative pain, clinical and radiographic outcomes of MTA pulpotomy compared to root canal treatment in children's first permanent molars suffering from irreversible pulpitis.
Detailed description
In this randomized controlled trial, patients aged 10-14 years suffering from irreversible pulpitis in the first permanent molar with closed apex will be randomly divided into two groups. The first group will receive complete coronal MTA pulpotomy, while the second group will receive endodontic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTA Pulpotomy | Experimental | Procedure: MTA PulpotomyLocal anesthesia for pain control will be administered, followed by rubber dam isolation. Then, the tooth and surrounding rubber dam will be flushed with chlorhexidine solution for disinfection. After caries removal, a sterile bur will be used for access opening and complete deroofing of the pulp chamber. Coronal pulp tissue will be removed to the level of canal orifices using a sterile, sharp spoon excavator. A cotton pellet dampened with sodium hypochlorite will be applied on canal orifices to achieve hemostasis. This will be followed by MTA application and glass ionomer restoration. If necessary, the tooth will be restored with stainless steel crown after one week. |
| Root Canal Treatment | Active comparator | Procedure: Root Canal TreatmentLocal anesthesia for pain control will be administered, followed by rubber dam isolation. Then, the tooth and surrounding rubber dam will be flushed with chlorhexidine solution for disinfection. After caries removal, a sterile bur will be used for access opening and complete deroofing of the pulp chamber. Length of the root canal will be obtained using an apex locator. This will be followed by mechanical shaping using files, and irrigation with 2.5 percent sodium hypochlorite, followed by drying of the canals using paper points. Obturation will then be accomplished using gutta percha and sealer. Finally, the tooth will be restored with conventional glass ionomer restoration. If necessary, the tooth will be restored with stainless steel crown after one week. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy male and female children, aged 10 to 14 years
- Signs and symptoms of irreversible pulpitis in carious first permanent molar.
Key exclusion criteria (4 listed)
- Molars with immature roots
- Non-restorable molars, with abnormal mobility or increased probing pocket depth (normal range = 1-3 mm)
- Any indication of pulpal necrosis, such as sinus tract or swelling or no bleeding from orifices after access opening.
- Any signs of periapical or furcal rarefaction.
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 |
|---|---|---|
| MTA PulpotomyAlso: Vital Pulp TherapyComplete coronal MTA pulpotomy. | Procedure or surgery | MTA Pulpotomy |
| Root Canal TreatmentAlso: Endodontic TreatmentConventional root canal treatment. | Procedure or surgery | Root Canal Treatment |
Primary outcome
Pain Relief
Time frame: preoperatively, immediately postoperatively and every 24 hours for 7 days after the first appointment.
A 10 cm visual analogue scale will be used to record pain
2 secondary outcomes
Clinical Evaluation
Time frame: 3, 6, 12 and 18 months postoperatively
Radiographic Evaluation
Time frame: 6, 12 and 18 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Results publication: PubMed 29061359Galani M, Tewari S, Sangwan P, Mittal S, Kumar V, Duhan J. Comparative Evaluation of Postoperative Pain and Success Rate after Pulpotomy and Root Canal Treatment in Cariously Exposed Mature Permanent Molars: A Randomized Controlled Trial. J Endod. 2017 Dec;43(12):1953-1962. doi: 10.1016/j.joen.2017.08.007. Epub 2017 Oct 20.
- Results publication: 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.
- Results publication: PubMed 34854987Asgary S, Eghbal MJ, Shahravan A, Saberi E, Baghban AA, Parhizkar A. Outcomes of root canal therapy or full pulpotomy using two endodontic biomaterials in mature permanent teeth: a randomized controlled trial. Clin Oral Investig. 2022 Mar;26(3):3287-3297. doi: 10.1007/s00784-021-04310-y. Epub 2021 Dec 2.
- Results publication: PubMed 35160239Beauquis J, Setbon HM, Dassargues C, Carsin P, Aryanpour S, Van Nieuwenhuysen JP, Leprince JG. Short-Term Pain Evolution and Treatment Success of Pulpotomy as Irreversible Pulpitis Permanent Treatment: A Non-Randomized Clinical Study. J Clin Med. 2022 Jan 31;11(3):787. doi: 10.3390/jcm11030787.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
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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.
Alaa A. Eissa, Msc principal investigator
Faculty of Dentistry, Ain Shams University, Cairo, Egypt
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MTA Pulpotomy and Root Canal Treatment in people with Irreversible Pulpitis, run by Ain Shams University.
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 2 inclusion and 4 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 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Alaa A. Eissa, Msc (00201012036000, alaaeissa@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Relief (time frame: preoperatively, immediately postoperatively and every 24 hours for 7 days after the first appointment.). 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 NCT06488131, which also lists 4 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 5 Jul 2024.