Irreversible PulpitisNCT04573374
Comparing the Outcome of Pulpotomy Using Biodentine and Portland Cement in Mature Cases With Irreversible Pulpitis: Randomized Clinical Trial
A study testing Pulpotomy in people with Irreversible Pulpitis, run by Cairo University.
Trial summary
The aim of the study is to compare the treatment outcome of pulpotomy using Biodentine or Portland cement regarding success rate and post-operative pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Aug 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Exposed permanent teeth with mature roots.
- Asymptomatic irreversible pulpitis (no or mild symptoms) and Symptomatic irreversible pulpitis {spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (interpreted as lingering pain)} compared to contralateral normal teeth, and which could be reproduced using cold testing.
- Pre-operative pain assessed as none (but clinically exposed), moderate or severe on Numerical Rating Scale (NRS).
- The tooth is restorable and free from advanced periodontal disease.
- Soft tissues around the tooth are normal with no swelling or sinus tract.
- Vital bleeding pulp tissue should be present in all canals after pulpotomy.
- Age: more than 18 years
Who cannot join
- Immature teeth.
- Necrotic pulp and absence of bleeding upon exposure.
- Teeth unresponsive to cold stimulation, presence of sinus tracts or swelling, presence of periapical rarefaction, internal or external root resorption or root canal calcification on radiograph.
- Non-restorable teeth or teeth indicated for post and core restoration
- Teeth with severe periodontal disease.
- Any serious medical problem that prevented the patient from receiving treatment or attending follow-up visits. Pregnant or lactating female patients.
- Patients who used long-acting Non-steroidal anti-inflammatory drugs (NSAIDs) before treatment.
Trial locations and contacts
No sites are listed yet.
Ghada Eid, phD contact
About this study
The aim of the study is to compare the treatment outcome of pulpotomy using Biodentine or Portland cement regarding success rate and post-operative pain.
Read the detailed description
- Patients will be screened for eligibility through obtaining medical and dental histories together with clinical [visual, palpation, percussion, cold sensitivity testing and probing] and radiographic evaluations for the teeth.
- After ensuring eligibilty, profound local anesthesia of the tooth will be achieved using 4% Articaine with 1: 100000 epinephrine (Septodont. Saint-Maur-des-Fosses. France).
- Caries will be removed using a round, high-speed bur with adequate water cooling.
- Cases will be randomly divided into two groups according to pulpotomy material either: Biodentine or Portland cement. Biodentine is mixed according to manufacturer's instructions and placed in a 2-3 mm layer above the pulp tissue using an amalgam carrier and gently packed using a condenser. Initial setting is achieved after 12 minutes. Preparation of Portland cement: Industrial Portland cement is mixed with Bisthmus oxide or Barium sulphate radio-opacifier in a 3:1 ratio. The mix is sieved through silk sieve then sterilized in hot air oven at 135 ֯C for 2 hours. Portland cement is mixed in a 3:1 powder: distilled water ratio and placed in the pulp chamber and condensed against a moist cotton pellet. A small cotton pellet moistened with saline is placed in the pulp chamber against PC for 5 seconds to ensure water uptake then removed.
- Appropriate interim restoration will be done and checked throughout follow up period. Patients will be referred for final restoration after endpoint of research. A post-operative periapical radiograph is taken after interim restoration placement.
- Patients will be contacted by telephone by the same operator to record pain intensity (at 6, 12, 24, 48 and after 7 days).
- Clinical and radiographic evaluation is scheduled at 3 months postoperatively, and the outcome will be determined according to clinical and radiographic criteria. Clinical criteria include: absence of tenderness to palpation or percussion and the tooth is functional, normal mobility and probing pocket depth. Soft tissues around the tooth are normal with no swelling or sinus tract. Radiographic criteria include: absence of periapical pathosis evident on the radiograph such as root resorption, root canal calcification, furcal pathosis or new periapical rarefaction. In case of failure, the tooth will be treated endodontically and referred for final restoration.
- Conditions
- Irreversible Pulpitis
- Being tested
- Pulpotomy
- Keywords
- irreversible pulpitis, pulpotomy, Biodentine, Portland cement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpotomyProcedure or surgery
Also called Vital pulp therapy
Pulpotomy is the term for removal of the coronal pulp with the intent of maintaining the vitality of the remaining radicular pulp tissue.
| Study group | Role | What they receive |
|---|---|---|
| Biodentine | Active comparator | Biodentine (BD; Septodont, St Maur-des-Fosses, France) is a calcium silicate capping material. Biodentine is mixed according to manufacturer's instructions and placed in a 2-3 mm layer above the pulp tissue using an amalgam carrier and gently packed using a condenser. Initial setting is achieved after 12 minutes. Receives: Procedure: Pulpotomy |
| Portland cement | Active comparator | Preparation of Portland cement: Industrial Portland cement is mixed with Bisthmus oxide or Barium sulphate radio-opacifier in a 3:1 ratio. The mix is sieved through silk sieve then sterilized in hot air oven at 135 ֯C for 2 hours. Portland cement is mixed in a 3:1 powder: distilled water ratio and placed in the pulp chamber and condensed against a moist cotton pellet. A small cotton pellet moistened with saline is placed in the pulp chamber against PC for 5 seconds to ensure water uptake then removed Receives: Procedure: Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulpotomy Success rate
Clinical and radiographic evaluation is scheduled at 3 months postoperatively, and the outcome will be determined according to clinical and radiographic criteria. Clinical criteria include: absence of tenderness to palpation or percussion and the tooth is functional, normal mobility and probing pocket depth. Soft tissues around the tooth are normal with no swelling or sinus tract. Radiographic criteria include: absence of periapical pathosis evident on the radiograph such as root resorption, root canal calcification, furcal pathosis or new periapical rarefaction. In case of failure, the tooth will be treated endodontically and referred for final restoration.
Measured: 3 months
Pulpotomy success rate
Clinical and radiographic evaluation is scheduled at 6 months postoperatively, and the outcome will be determined according to clinical and radiographic criteria. Clinical criteria include: absence of tenderness to palpation or percussion and the tooth is functional, normal mobility and probing pocket depth. Soft tissues around the tooth are normal with no swelling or sinus tract. Radiographic criteria include: absence of periapical pathosis evident on the radiograph such as root resorption, root canal calcification, furcal pathosis or new periapical rarefaction. In case of failure, the tooth will be treated endodontically and referred for final restoration.
Measured: 6 months
Pulpotomy success rate
Clinical and radiographic evaluation is scheduled at 12 months postoperatively, and the outcome will be determined according to clinical and radiographic criteria. Clinical criteria include: absence of tenderness to palpation or percussion and the tooth is functional, normal mobility and probing pocket depth. Soft tissues around the tooth are normal with no swelling or sinus tract. Radiographic criteria include: absence of periapical pathosis evident on the radiograph such as root resorption, root canal calcification, furcal pathosis or new periapical rarefaction. In case of failure, the tooth will be treated endodontically and referred for final restoration.
Measured: 12 months
Secondary outcomes (1)
Post-operative pain
Patients will be contacted by telephone by the same operator to record pain intensity on Numerical Rating Scale (NRS)
Measured: 6, 12, 24, 48 hours and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study startNov 2020 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionAug 2022 (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 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
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Ahmed Youssef, Cairo University
- Investigators
- Aya A Gamal, MSc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573374
- Sponsor's protocol ID
- CEBD-CU-2020-09-17
- Status last verified
- Sep 2020
- First submitted
- 27 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Awawdeh L, Al-Qudah A, Hamouri H, Chakra RJ. Outcomes of Vital Pulp Therapy Using Mineral Trioxide Aggregate or Biodentine: A Prospective Randomized Clinical Trial. J Endod. 2018 Nov;44(11):1603-1609. doi: 10.1016/j.joen.2018.08.004. Epub 2018 Oct 3.
PubMed 30292451Li Y, Sui B, Dahl C, Bergeron B, Shipman P, Niu L, Chen J, Tay FR. Pulpotomy for carious pulp exposures in permanent teeth: A systematic review and meta-analysis. J Dent. 2019 May;84:1-8. doi: 10.1016/j.jdent.2019.03.010. Epub 2019 Apr 11.
PubMed 30981748Danesh G, Dammaschke T, Gerth HU, Zandbiglari T, Schafer E. A comparative study of selected properties of ProRoot mineral trioxide aggregate and two Portland cements. Int Endod J. 2006 Mar;39(3):213-9. doi: 10.1111/j.1365-2591.2006.01076.x.
PubMed 16507075
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Outcome of Pulpotomy Using Biodentine and Portland Cement in Mature Cases With Irreversible Pulpitis: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04573374
- Acronym / sponsor ID
- CEBD-CU-2020-09-17
- Conditions
- Irreversible Pulpitis
- Keywords
- irreversible pulpitis, pulpotomy, Biodentine, Portland cement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 5 Oct 2020 (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.
The aim of the study is to compare the treatment outcome of pulpotomy using Biodentine or Portland cement regarding success rate and post-operative pain.
Detailed description
- Patients will be screened for eligibility through obtaining medical and dental histories together with clinical [visual, palpation, percussion, cold sensitivity testing and probing] and radiographic evaluations for the teeth.
- After ensuring eligibilty, profound local anesthesia of the tooth will be achieved using 4% Articaine with 1: 100000 epinephrine (Septodont. Saint-Maur-des-Fosses. France).
- Caries will be removed using a round, high-speed bur with adequate water cooling.
- Cases will be randomly divided into two groups according to pulpotomy material either: Biodentine or Portland cement. Biodentine is mixed according to manufacturer's instructions and placed in a 2-3 mm layer above the pulp tissue using an amalgam carrier and gently packed using a condenser. Initial setting is achieved after 12 minutes. Preparation of Portland cement: Industrial Portland cement is mixed with Bisthmus oxide or Barium sulphate radio-opacifier in a 3:1 ratio. The mix is sieved through silk sieve then sterilized in hot air oven at 135 ֯C for 2 hours. Portland cement is mixed in a 3:1 powder: distilled water ratio and placed in the pulp chamber and condensed against a moist cotton pellet. A small cotton pellet moistened with saline is placed in the pulp chamber against PC for 5 seconds to ensure water uptake then removed.
- Appropriate interim restoration will be done and checked throughout follow up period. Patients will be referred for final restoration after endpoint of research. A post-operative periapical radiograph is taken after interim restoration placement.
- Patients will be contacted by telephone by the same operator to record pain intensity (at 6, 12, 24, 48 and after 7 days).
- Clinical and radiographic evaluation is scheduled at 3 months postoperatively, and the outcome will be determined according to clinical and radiographic criteria. Clinical criteria include: absence of tenderness to palpation or percussion and the tooth is functional, normal mobility and probing pocket depth. Soft tissues around the tooth are normal with no swelling or sinus tract. Radiographic criteria include: absence of periapical pathosis evident on the radiograph such as root resorption, root canal calcification, furcal pathosis or new periapical rarefaction. In case of failure, the tooth will be treated endodontically and referred for final restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biodentine | Active comparator | Procedure: PulpotomyBiodentine (BD; Septodont, St Maur-des-Fosses, France) is a calcium silicate capping material. Biodentine is mixed according to manufacturer's instructions and placed in a 2-3 mm layer above the pulp tissue using an amalgam carrier and gently packed using a condenser. Initial setting is achieved after 12 minutes. |
| Portland cement | Active comparator | Procedure: PulpotomyPreparation of Portland cement: Industrial Portland cement is mixed with Bisthmus oxide or Barium sulphate radio-opacifier in a 3:1 ratio. The mix is sieved through silk sieve then sterilized in hot air oven at 135 ֯C for 2 hours. Portland cement is mixed in a 3:1 powder: distilled water ratio and placed in the pulp chamber and condensed against a moist cotton pellet. A small cotton pellet moistened with saline is placed in the pulp chamber against PC for 5 seconds to ensure water uptake then removed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Exposed permanent teeth with mature roots.
- Asymptomatic irreversible pulpitis (no or mild symptoms) and Symptomatic irreversible pulpitis {spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (interpreted as lingering pain)} compared to contralateral normal teeth, and which could be reproduced using cold testing.
- Pre-operative pain assessed as none (but clinically exposed), moderate or severe on Numerical Rating Scale (NRS).
- The tooth is restorable and free from advanced periodontal disease.
- Soft tissues around the tooth are normal with no swelling or sinus tract.
Key exclusion criteria (7 listed)
- Immature teeth.
- Necrotic pulp and absence of bleeding upon exposure.
- Teeth unresponsive to cold stimulation, presence of sinus tracts or swelling, presence of periapical rarefaction, internal or external root resorption or root canal calcification on radiograph.
- Non-restorable teeth or teeth indicated for post and core restoration
- Teeth with severe periodontal disease.
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: Vital pulp therapyPulpotomy is the term for removal of the coronal pulp with the intent of maintaining the vitality of the remaining radicular pulp tissue. | Procedure or surgery | Biodentine, Portland cement |
Primary outcome
Pulpotomy Success rate
Time frame: 3 months
Clinical and radiographic evaluation is scheduled at 3 months postoperatively, and the outcome will be determined according to clinical and radiographic criteria. Clinical criteria include: absence of tenderness to palpation or percussion and the tooth is functional, normal mobility and probing pocket depth. Soft tissues around the tooth are normal with no swelling or sinus tract. Radiographic criteria include: absence of periapical pathosis evident on the radiograph such as root resorption, root canal calcification, furcal pathosis or new periapical rarefaction. In case of failure, the tooth will be treated endodontically and referred for final restoration.
Pulpotomy success rate
Time frame: 6 months
Clinical and radiographic evaluation is scheduled at 6 months postoperatively, and the outcome will be determined according to clinical and radiographic criteria. Clinical criteria include: absence of tenderness to palpation or percussion and the tooth is functional, normal mobility and probing pocket depth. Soft tissues around the tooth are normal with no swelling or sinus tract. Radiographic criteria include: absence of periapical pathosis evident on the radiograph such as root resorption, root canal calcification, furcal pathosis or new periapical rarefaction. In case of failure, the tooth will be treated endodontically and referred for final restoration.
Pulpotomy success rate
Time frame: 12 months
Clinical and radiographic evaluation is scheduled at 12 months postoperatively, and the outcome will be determined according to clinical and radiographic criteria. Clinical criteria include: absence of tenderness to palpation or percussion and the tooth is functional, normal mobility and probing pocket depth. Soft tissues around the tooth are normal with no swelling or sinus tract. Radiographic criteria include: absence of periapical pathosis evident on the radiograph such as root resorption, root canal calcification, furcal pathosis or new periapical rarefaction. In case of failure, the tooth will be treated endodontically and referred for final restoration.
1 secondary outcome
Post-operative pain
Time frame: 6, 12, 24, 48 hours and 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Background: PubMed 30292451Awawdeh L, Al-Qudah A, Hamouri H, Chakra RJ. Outcomes of Vital Pulp Therapy Using Mineral Trioxide Aggregate or Biodentine: A Prospective Randomized Clinical Trial. J Endod. 2018 Nov;44(11):1603-1609. doi: 10.1016/j.joen.2018.08.004. Epub 2018 Oct 3.
- Background: PubMed 30981748Li Y, Sui B, Dahl C, Bergeron B, Shipman P, Niu L, Chen J, Tay FR. Pulpotomy for carious pulp exposures in permanent teeth: A systematic review and meta-analysis. J Dent. 2019 May;84:1-8. doi: 10.1016/j.jdent.2019.03.010. Epub 2019 Apr 11.
- Background: PubMed 16507075Danesh G, Dammaschke T, Gerth HU, Zandbiglari T, Schafer E. A comparative study of selected properties of ProRoot mineral trioxide aggregate and two Portland cements. Int Endod J. 2006 Mar;39(3):213-9. doi: 10.1111/j.1365-2591.2006.01076.x.
- 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.
Ghada Eid, phD contact
Aya A Gamal, MSc principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Pulpotomy in people with 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 7 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 Oct 2020. 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 Aya A Gamal, MSc (01111078317, aya.youssef@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulpotomy Success rate (time frame: 3 months). The study lists 3 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 NCT04573374, 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 5 Oct 2020.