Carious Exposure of PulpNCT05279820
Comparative Study of the Outcome of Partial and Full Pulpotomy in Irreversible Pulpits
A study testing Partial pulpotomy and Full Pulpotomy in people with Carious Exposure of Pulp and Irreversible Pulpitis, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
This study aims at comparing the outcome of partial pulpotomy and full pulpotomy in the management of carious pulp exposures in permanent teeth with a clinical diagnosis of irreversible pulpits. Read more about this study
- Who is it for?
- Ages 10 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Carious Exposure of Pulp, Irreversible Pulpitis, Pulpotomy
- What is being tested?
- Partial pulpotomy and Full Pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jun 2021to Jan 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 10 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mature permanent tooth
- Deep caries extending more than two thirds of dentine or exposing the pulp
- Tooth responds positively to cold test
- Clinical symptoms of irreversible pulpits
- Tooth is restorable and can be restored with coronal restoration
- Bleeding normally is confirmed after pulp exposure
- hemostasis could be achieved within 8 minutes
Who cannot join
- Non restorable teeth
- necrotic teeth
- hemostasis could not be achieved within 8 minutes
Trial locations and contacts
1 site in 1 country.
Nessrin Taha, PhD contact
Jordan1 site, 1 recruiting
- Recruiting
Jordan University of science and technology
Irbid, 22110
Nessrin Taha, DCD, n.taha@just.edu.jo
About this study
Official title: Full Versus Partial Pulpotomy in the Management of Teeth With Clinical Diagnosis of Irreversible Pulpits: A Randomized Clinical Trial
This study aims at comparing the outcome of partial pulpotomy and full pulpotomy in the management of carious pulp exposures in permanent teeth with a clinical diagnosis of irreversible pulpits. The primary outcome is resolution of symptoms and the secondary outcome is clinical and radiographic normality at 1 and 2 years follow up.
The study design will be a double blind randomized clinical trial.
Read the detailed description
Aim: to compare the outcome of partial and full pulpotomy in managing carious pulp exposures in mature permanent teeth with symptoms of irreversible pulpitis
Methods: Assuming a 10% difference in the success rate in favor of pulpotomy, with 80% power and accounting for possible 10% attrition, the minimum sample size required is estimated to be 80 teeth in 80 patients in every arm.
Patients referred to the postgraduate Endodontic clinic for management of deep carious lesions with symptoms of irreversible pulpits will be assessed for inclusion in the study according to preset inclusion criteria. After a written informed consent baseline demographics of patients and teeth will be recorded.
Pulpotomy (partial or full using block randomization) will be performed under aseptic procedures and the tooth will be permanently restored. Post operative baseline radiographs will be taken.
Primary outcome will be assessed after 48 hours. secondary outcome will be assessed at 6 months, 1 year and 2 years post operatively.
Data of outcome and effect of preoperative and intraoperative variables on the outcome will be compared statistically using appropriate tests
- Conditions
- Carious Exposure of Pulp, Irreversible Pulpitis, Pulpotomy
- Being tested
- Partial pulpotomy, Full Pulpotomy
- Keywords
- irreversible pulpits, Pulpotomy, Outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial pulpotomyProcedure or surgery
Partial pulp tissue amputation
Full PulpotomyProcedure or surgery
Full Pulpotomy
| Study group | Role | What they receive |
|---|---|---|
| Partial Pulpotomy | Active comparator | After pulp exposure 2-3 mm of the pulp tissue will be amputated, a calcium silicate based material will be placed over the pulp and the tooth will be restored. Receives: Procedure: Partial pulpotomy |
| Full Pulpotomy | Active comparator | After pulp exposure the entire coronal pulp to the level of canal orifices will be amputated , calcium silicate based material will be placed over the pulp and the tooth will be restored. Receives: Procedure: Full Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain level measured by visual analogy scale from 0-10
scale from 0-10
Measured: 48 hours
Post operative pain level measured by a numerical scale from 0-10
scale from 0-10
Measured: 48 hours
Secondary outcomes (2)
Clinical success as measured by clinical examination
The tooth should be pain free, no sinus tract or swelling, no tenderness to palpation as determined by clinical examination
Measured: 6, 12, 24 months
Radiographic success as evaluated by periapical x-rays
There should be no evidence of bone resorption or root resorption on the x-ray
Measured: 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start1 Jun 2021
- Primary completionJan 2023 (estimated)
- Study completionJan 2024 (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 Carious Exposure of PulpStudies 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
- The study will run concurrently and the participants will randomly distributed between the two interventions using a block randomization procedure
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nessrin Taha, PhD, Study chair, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279820
- Sponsor's protocol ID
- 329/2021
- Status last verified
- Mar 2022
- First submitted
- 28 Nov 2021
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Until the time of completion of the study, ankylosis of data and submission for publication, then data can be provided to other researchers
Publications
Taha NA, About I, Sedgley CM, Messer HH. Conservative Management of Mature Permanent Teeth with Carious Pulp Exposure. J Endod. 2020 Sep;46(9S):S33-S41. doi: 10.1016/j.joen.2020.06.025.
PubMed 32950193
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full Versus Partial Pulpotomy in the Management of Teeth With Clinical Diagnosis of Irreversible Pulpits: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05279820
- Acronym / sponsor ID
- 329/2021
- Conditions
- Carious Exposure of Pulp, Irreversible Pulpitis, Pulpotomy
- Keywords
- irreversible pulpits, Pulpotomy, Outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 15 Mar 2022 (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 study aims at comparing the outcome of partial pulpotomy and full pulpotomy in the management of carious pulp exposures in permanent teeth with a clinical diagnosis of irreversible pulpits. The primary outcome is resolution of symptoms and the secondary outcome is clinical and radiographic normality at 1 and 2 years follow up.
The study design will be a double blind randomized clinical trial.
Detailed description
Aim: to compare the outcome of partial and full pulpotomy in managing carious pulp exposures in mature permanent teeth with symptoms of irreversible pulpitis
Methods: Assuming a 10% difference in the success rate in favor of pulpotomy, with 80% power and accounting for possible 10% attrition, the minimum sample size required is estimated to be 80 teeth in 80 patients in every arm.
Patients referred to the postgraduate Endodontic clinic for management of deep carious lesions with symptoms of irreversible pulpits will be assessed for inclusion in the study according to preset inclusion criteria. After a written informed consent baseline demographics of patients and teeth will be recorded.
Pulpotomy (partial or full using block randomization) will be performed under aseptic procedures and the tooth will be permanently restored. Post operative baseline radiographs will be taken.
Primary outcome will be assessed after 48 hours. secondary outcome will be assessed at 6 months, 1 year and 2 years post operatively.
Data of outcome and effect of preoperative and intraoperative variables on the outcome will be compared statistically using appropriate tests
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will run concurrently and the participants will randomly distributed between the two interventions using a block randomization procedure
| Arm | Type | Receives |
|---|---|---|
| Partial Pulpotomy | Active comparator | Procedure: Partial pulpotomyAfter pulp exposure 2-3 mm of the pulp tissue will be amputated, a calcium silicate based material will be placed over the pulp and the tooth will be restored. |
| Full Pulpotomy | Active comparator | Procedure: Full PulpotomyAfter pulp exposure the entire coronal pulp to the level of canal orifices will be amputated , calcium silicate based material will be placed over the pulp and the tooth will be restored. |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Mature permanent tooth
- Deep caries extending more than two thirds of dentine or exposing the pulp
- Tooth responds positively to cold test
- Clinical symptoms of irreversible pulpits
- Tooth is restorable and can be restored with coronal restoration
Key exclusion criteria (3 listed)
- Non restorable teeth
- necrotic teeth
- hemostasis could not be achieved within 8 minutes
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 |
|---|---|---|
| Partial pulpotomyPartial pulp tissue amputation | Procedure or surgery | Partial Pulpotomy |
| Full PulpotomyFull Pulpotomy | Procedure or surgery | Full Pulpotomy |
Primary outcome
Post operative pain level measured by visual analogy scale from 0-10
Time frame: 48 hours
scale from 0-10
Post operative pain level measured by a numerical scale from 0-10
Time frame: 48 hours
scale from 0-10
2 secondary outcomes
Clinical success as measured by clinical examination
Time frame: 6, 12, 24 months
Radiographic success as evaluated by periapical x-rays
Time frame: 6, 12, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Background: PubMed 32950193Taha NA, About I, Sedgley CM, Messer HH. Conservative Management of Mature Permanent Teeth with Carious Pulp Exposure. J Endod. 2020 Sep;46(9S):S33-S41. doi: 10.1016/j.joen.2020.06.025.
- Individual participant dataSharing planned: Undecided. Until the time of completion of the study, ankylosis of data and submission for publication, then data can be provided to other researchers
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Pulp Inflammatory Markers and Outcome of Pulpotomy
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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.
Nessrin Taha, PhD contact
Nessrin Taha, PhD study chair
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial pulpotomy and Full Pulpotomy in people with Carious Exposure of Pulp and Irreversible Pulpitis, run by Jordan University of Science and Technology at 1 site in Jordan.
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 3 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 15 Mar 2022. 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 Jordan. 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 Nessrin Taha, PhD (+962776566110, n.taha@just.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain level measured by visual analogy scale from 0-10 (time frame: 48 hours). 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 NCT05279820, 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 15 Mar 2022.