Symptomatic Irreversible PulpitisNCT05681494
Assessment of Pain and Treatment Success After VPT Versus RCT in Mature Permanent Mandibular Molars With SIP: A RCT
A study testing Root canal treatment and Vital pulp therapy in people with Symptomatic Irreversible Pulpitis, run by Cairo University.
Trial summary
Assessment of postoperative pain and treatment success after vital pulp therapy versus root canal treatment in mandibular molar with signs and symptoms of irreversible pulpitis. the null hypothesis, there is no difference will be observed in the pain level and treatment success between two treatments. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- Root canal treatment and Vital pulp therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 26 Feb 2023to 26 Jun 2024
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy patients.
- Patient's age range more than 15 years.
- Mature permanent mandibular molars with deep caries.
- Clinical diagnosis of symptomatic irreversible pulpitis.
- Teeth with no need for the post.
- Healthy periodontium and mobility within normal limits.
- Patients who can understand the pain scale and can sign the informed consent
Who cannot join
- Teeth with a negative response to vitality testing.
- Teeth with furcal bone loss.
- Teeth with sinus tract
- Teeth with swelling.
- Teeth with a non-restorable crown.
- Teeth with immature roots.
Show all 12Show fewer
- Teeth with no pulp exposure even after caries excavation.
- History of analgesic intake in the previous week.
- History of antibiotic intake in the previous month.
- Insufficient bleeding after pulp exposure suggestive of partial necrosis of the pulp.
- Inability to control bleeding within 10 min.
- Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Postoperative Pain and Treatment Success After Vital Pulp Therapy Versus Root Canal Treatment in Mature Permanent Mandibular Molars With Irreversible Pulpitis: A Randomized Controlled Trial
Assessment of postoperative pain and treatment success after vital pulp therapy versus root canal treatment in mandibular molar with signs and symptoms of irreversible pulpitis. the null hypothesis, there is no difference will be observed in the pain level and treatment success between two treatments.
Read the detailed description
After proper clinical and radiographic examination. Teeth will be anesthetized and isolated using a rubber dam. The operative field will be disinfected. Total caries removal will be done from outside making margin caries free to inside. the new diamond bur will be used to remove the last layer and exposed the pulp tissue. Exposed pulp will be inspected under a dental operating microscope and hemostasis will be obtained. The teeth will be randomized into 2 intervention groups (VPT or RCT). Treatment will be finalized, and teeth will be restored with resin-modified glass ionomer followed by composite resin at the same appointment. Ibuprofen 400mg will be prescribed to the patient if needed. Patients will be asked to record postoperative pain after treatment on the pain score sheet.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- Root canal treatment, Vital pulp therapy
- Keywords
- SIP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal treatmentProcedure or surgery
Also called RCT, Full pulpectomy
after access cavity preparation, the working length will be determined. chemo-mechanical preparation will be done, and teeth will be obturated. final restoration will be placed.
Vital pulp therapyProcedure or surgery
Also called pulpotomy
exposed pulp will be capped with 3 mm calcium silicate material
| Study group | Role | What they receive |
|---|---|---|
| Root canal treatment | Active comparator | after access cavity preparation, the working length will be determined. chemo-mechanical preparation will be done, and teeth will be obturated. final restoration will be placed. Receives: Procedure: Root canal treatment |
| Vital pulp therapy | Experimental | exposed pulp will be capped with 3 mm calcium silicate material Receives: Procedure: Vital pulp therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
postoperative pain will be recorded by patient using NRS
Measured: at 6 hours postoperative
Secondary outcomes (2)
Intensity of postoperative pain
postoperative pain will be recorded by patient using NRS
Measured: at 24, 48 hours and 7 days
Treatment success
clinical and radiographic success
Measured: at 3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start26 Feb 2023 (estimated)
- Primary completion26 Jul 2023 (estimated)
- Study completion26 Jun 2024 (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 Symptomatic Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Ibrahiem Ahmed Mohamed, Cairo University
- Investigators
- Ahmed S Elsheshtawy, Study director, Lecturer, Department of Endodontics, Faculty of Dentistry, Cairo university.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681494
- Sponsor's protocol ID
- 28/12/2022
- Status last verified
- Feb 2023
- First submitted
- 28 Dec 2022
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Taha NA, Al-Rawash MH, Imran ZA. Outcome of full pulpotomy in mature permanent molars using 3 calcium silicate-based materials: A parallel, double blind, randomized controlled trial. Int Endod J. 2022 May;55(5):416-429. doi: 10.1111/iej.13707. Epub 2022 Mar 17.
PubMed 35152464Santos JM, Pereira JF, Marques A, Sequeira DB, Friedman S. Vital Pulp Therapy in Permanent Mature Posterior Teeth with Symptomatic Irreversible Pulpitis: A Systematic Review of Treatment Outcomes. Medicina (Kaunas). 2021 Jun 3;57(6):573. doi: 10.3390/medicina57060573.
PubMed 34205149Taha NA, Al-Khatib H. 4-Year Follow-up of Full Pulpotomy in Symptomatic Mature Permanent Teeth with Carious Pulp Exposure Using a Stainproof Calcium Silicate-based Material. J Endod. 2022 Jan;48(1):87-95. doi: 10.1016/j.joen.2021.09.008. Epub 2021 Sep 24.
PubMed 34563506Asgary 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 34854987
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postoperative Pain and Treatment Success After Vital Pulp Therapy Versus Root Canal Treatment in Mature Permanent Mandibular Molars With Irreversible Pulpitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05681494
- Acronym / sponsor ID
- 28/12/2022
- Conditions
- Symptomatic Irreversible Pulpitis
- Keywords
- SIP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 26 Feb 2023 (estimated)
- Primary completion
- 26 Jul 2023 (estimated)
- Study completion
- 26 Jun 2024 (estimated)
- First posted
- 12 Jan 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.
Assessment of postoperative pain and treatment success after vital pulp therapy versus root canal treatment in mandibular molar with signs and symptoms of irreversible pulpitis. the null hypothesis, there is no difference will be observed in the pain level and treatment success between two treatments.
Detailed description
After proper clinical and radiographic examination. Teeth will be anesthetized and isolated using a rubber dam. The operative field will be disinfected. Total caries removal will be done from outside making margin caries free to inside. the new diamond bur will be used to remove the last layer and exposed the pulp tissue. Exposed pulp will be inspected under a dental operating microscope and hemostasis will be obtained. The teeth will be randomized into 2 intervention groups (VPT or RCT). Treatment will be finalized, and teeth will be restored with resin-modified glass ionomer followed by composite resin at the same appointment. Ibuprofen 400mg will be prescribed to the patient if needed. Patients will be asked to record postoperative pain after treatment on the pain score sheet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Root canal treatment | Active comparator | Procedure: Root canal treatmentafter access cavity preparation, the working length will be determined. chemo-mechanical preparation will be done, and teeth will be obturated. final restoration will be placed. |
| Vital pulp therapy | Experimental | Procedure: Vital pulp therapyexposed pulp will be capped with 3 mm calcium silicate material |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Systemically healthy patients.
- Patient's age range more than 15 years.
- Mature permanent mandibular molars with deep caries.
- Clinical diagnosis of symptomatic irreversible pulpitis.
- Teeth with no need for the post.
Key exclusion criteria (12 listed)
- Teeth with a negative response to vitality testing.
- Teeth with furcal bone loss.
- Teeth with sinus tract
- Teeth with swelling.
- Teeth with a non-restorable crown.
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 treatmentAlso: RCT, Full pulpectomyafter access cavity preparation, the working length will be determined. chemo-mechanical preparation will be done, and teeth will be obturated. final restoration will be placed. | Procedure or surgery | Root canal treatment |
| Vital pulp therapyAlso: pulpotomyexposed pulp will be capped with 3 mm calcium silicate material | Procedure or surgery | Vital pulp therapy |
Primary outcome
Postoperative pain
Time frame: at 6 hours postoperative
postoperative pain will be recorded by patient using NRS
2 secondary outcomes
Intensity of postoperative pain
Time frame: at 24, 48 hours and 7 days
Treatment success
Time frame: at 3,6,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Background: PubMed 35152464Taha NA, Al-Rawash MH, Imran ZA. Outcome of full pulpotomy in mature permanent molars using 3 calcium silicate-based materials: A parallel, double blind, randomized controlled trial. Int Endod J. 2022 May;55(5):416-429. doi: 10.1111/iej.13707. Epub 2022 Mar 17.
- Background: PubMed 34205149Santos JM, Pereira JF, Marques A, Sequeira DB, Friedman S. Vital Pulp Therapy in Permanent Mature Posterior Teeth with Symptomatic Irreversible Pulpitis: A Systematic Review of Treatment Outcomes. Medicina (Kaunas). 2021 Jun 3;57(6):573. doi: 10.3390/medicina57060573.
- Background: PubMed 34563506Taha NA, Al-Khatib H. 4-Year Follow-up of Full Pulpotomy in Symptomatic Mature Permanent Teeth with Carious Pulp Exposure Using a Stainproof Calcium Silicate-based Material. J Endod. 2022 Jan;48(1):87-95. doi: 10.1016/j.joen.2021.09.008. Epub 2021 Sep 24.
- Background: 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.
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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.
Ahmed S Elsheshtawy study director
Lecturer, Department of Endodontics, Faculty of Dentistry, Cairo university.
Questions about this trial
What is this clinical trial studying?
A study testing Root canal treatment and Vital pulp therapy in people with Symptomatic Irreversible Pulpitis, run by Cairo 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 7 inclusion and 12 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 16 Feb 2023. 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.
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 Amany IA mohamed, phd (01099300346 ext. 002, amany.ahmed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: at 6 hours postoperative). 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 NCT05681494, 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 16 Feb 2023.