Root Canal InfectionNCT04933955
Evaluation of Post Operative Pain and Success Rate After Pulpotomy
A study testing vital pulp therapy in people with Root Canal Infection, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this randomized controlled trial is to assess the post-operative pain as primary outcome and the success rate as secondary outcome after pulpotomy using different calcium silicate based materials in mature permanent teeth diagnosed with irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal Infection
- What is being tested?
- vital pulp therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Dec 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients age between 20 and 40 years old.
- Teeth diagnosed with symptomatic irreversible pulpitis.
- Normal periapical condition confirmed by normal periapical radiograph or that with minimal widening of the PDL space.
- The teeth are restorable.
- Teeth probing depth and mobility should be within normal limits.
Who cannot join
- Teeth with immature roots
- Non restorable teeth
- Bleeding could not be controlled after pulpotomy in 10 minutes.
- Medically compromised patients with systemic complication that would alter the treatment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo
shehabeldin m saber, prof, +201001413734, saberse@asfd.asu.edu.eg
About this study
Official title: Comparative Evaluation of Post Operative Pain and Success Rate After Pulpotomy Using Different Tricalcium Silicate Based Materials (A Randomized Clinical Trial )
The aim of this randomized controlled trial is to assess the post-operative pain as primary outcome and the success rate as secondary outcome after pulpotomy using different calcium silicate based materials in mature permanent teeth diagnosed with irreversible pulpitis.
Read the detailed description
Setting and location :
Out-patients clinic of Endodontic Department, Faculty of Dentistry, Ain Shams University
Patient allocation:
Using computer generated randomization (www.randome.org), the participants will allocated randomly into three groups .
The sequentially numbers that will be generated, will be placed in opaque envelope until the intervention and each participant will be asked to select an envelope that determine which group of intervention he will be assigned.
Patient Classification:
Patients will be randomly divided into three groups according to material used in pulpotomy Group (1) Biodentine (n=20) Group (2) theracal PT (n=20) Group (3) Neoputty (n=20)
Procedural steps:
- Pain scale chart will be given to each patient to rate his /her pain level before endodontic treatment as preoperative reading on a visual analogue scale (VAS)
- Tooth will be anaesthetized using Local anesthesia containing Articaine with epinephrine 1:100,000.
- Rubber dam isolation of tooth
- Tooth surface disinfection using guaze soaked in 5.25% sodium hypochlorite
- Access cavity will be performed using a carbide steel round bur and tapered diamond stone until complete deroofing.
- Using a sterile excavator, the coronal pulp tissue will be excavated14
- Cotton pellets soaked in 2.5 % sodium hypochlorite will be used to achieve hemostasis for 2-3 minutes
- Once hemostasis will be achieved one of the three materials will be placed according to the manufacturer's instructions
- Final restoration will be placed
Methods of evaluation
- Post operative pain
- Pulpotomy success rate
- Conditions
- Root Canal Infection
- Being tested
- vital pulp therapy
- Keywords
- pulpotomy, Tricalcium silicate, Biodentine, vital pulp therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vital pulp therapyProcedure or surgery
pulpotomy
| Study group | Role | What they receive |
|---|---|---|
| biodentine | Active comparator | pulptomy with biodentine Receives: Procedure: vital pulp therapy |
| Theracal PT | Active comparator | pulpotomy with Theracal PT Receives: Procedure: vital pulp therapy |
| Neo Putty | Active comparator | pulpotomy with Neo putty Receives: Procedure: vital pulp therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain
Each patient will be asked to fill the visual analogue scale to rate the pain level
Measured: pre-operative
post operative pain
Each patient will be asked to fill the visual analogue scale to rate the pain level
Measured: 6 hours following the end of the procedure.
post operative pain
Each patient will be asked to fill the visual analogue scale to rate the pain level
Measured: 12 hours following the end of the procedure.
post operative pain
Each patient will be asked to fill the visual analogue scale to rate the pain level
Measured: 24 hours following the end of the procedure.
post operative pain
Each patient will be asked to fill the visual analogue scale to rate the pain level
Measured: 48 hours following the end of the procedure.
post operative pain
Each patient will be asked to fill the visual analogue scale to rate the pain level
Measured: 72 hours following the end of the procedure.
Secondary outcomes (5)
Pulpotomy success
clinical and radiographic absence of inflammation
Measured: 3 months after the intervention
Pulpotomy success
clinical and radiographic absence of inflammation
Measured: 6 months after the intervention
Pulpotomy success
clinical and radiographic absence of inflammation
Measured: 9 months after the intervention
Pulpotomy success
clinical and radiographic absence of inflammation
Measured: 12 months after the intervention
Pulpotomy success
clinical and radiographic absence of inflammation
Measured: 18 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 Jun 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Dec 2022 (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 Root Canal InfectionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shehab El Din Mohamed Saber, Ain Shams University
- Investigators
- Ahmed Abdel Rahman Hashem, phd, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933955
- Sponsor's protocol ID
- 7/6/21
- Status last verified
- Jun 2021
- First submitted
- 7 Jun 2021
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haikal L, Ferraz Dos Santos B, Vu DD, Braniste M, Dabbagh B. Biodentine Pulpotomies on Permanent Traumatized Teeth with Complicated Crown Fractures. J Endod. 2020 Sep;46(9):1204-1209. doi: 10.1016/j.joen.2020.06.003. Epub 2020 Jun 15.
PubMed 32553879
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Post Operative Pain and Success Rate After Pulpotomy Using Different Tricalcium Silicate Based Materials (A Randomized Clinical Trial )
- ClinicalTrials.gov ID
- NCT04933955
- Acronym / sponsor ID
- 7/6/21
- Conditions
- Root Canal Infection
- Keywords
- pulpotomy, Tricalcium silicate, Biodentine, vital pulp therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 22 Jun 2021 (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 this randomized controlled trial is to assess the post-operative pain as primary outcome and the success rate as secondary outcome after pulpotomy using different calcium silicate based materials in mature permanent teeth diagnosed with irreversible pulpitis.
Detailed description
Setting and location :
Out-patients clinic of Endodontic Department, Faculty of Dentistry, Ain Shams University
Patient allocation:
Using computer generated randomization (www.randome.org), the participants will allocated randomly into three groups .
The sequentially numbers that will be generated, will be placed in opaque envelope until the intervention and each participant will be asked to select an envelope that determine which group of intervention he will be assigned.
Patient Classification:
Patients will be randomly divided into three groups according to material used in pulpotomy Group (1) Biodentine (n=20) Group (2) theracal PT (n=20) Group (3) Neoputty (n=20)
Procedural steps:
- Pain scale chart will be given to each patient to rate his /her pain level before endodontic treatment as preoperative reading on a visual analogue scale (VAS)
- Tooth will be anaesthetized using Local anesthesia containing Articaine with epinephrine 1:100,000.
- Rubber dam isolation of tooth
- Tooth surface disinfection using guaze soaked in 5.25% sodium hypochlorite
- Access cavity will be performed using a carbide steel round bur and tapered diamond stone until complete deroofing.
- Using a sterile excavator, the coronal pulp tissue will be excavated14
- Cotton pellets soaked in 2.5 % sodium hypochlorite will be used to achieve hemostasis for 2-3 minutes
- Once hemostasis will be achieved one of the three materials will be placed according to the manufacturer's instructions
- Final restoration will be placed
Methods of evaluation
- Post operative pain
- Pulpotomy success rate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| biodentine | Active comparator | Procedure: vital pulp therapypulptomy with biodentine |
| Theracal PT | Active comparator | Procedure: vital pulp therapypulpotomy with Theracal PT |
| Neo Putty | Active comparator | Procedure: vital pulp therapypulpotomy with Neo putty |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients age between 20 and 40 years old.
Key exclusion criteria (4 listed)
- Teeth with immature roots
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 |
|---|---|---|
| vital pulp therapypulpotomy | Procedure or surgery | Neo Putty, Theracal PT, biodentine |
Primary outcome
post operative pain
Time frame: pre-operative
Each patient will be asked to fill the visual analogue scale to rate the pain level
post operative pain
Time frame: 6 hours following the end of the procedure.
Each patient will be asked to fill the visual analogue scale to rate the pain level
post operative pain
Time frame: 12 hours following the end of the procedure.
Each patient will be asked to fill the visual analogue scale to rate the pain level
post operative pain
Time frame: 24 hours following the end of the procedure.
Each patient will be asked to fill the visual analogue scale to rate the pain level
post operative pain
Time frame: 48 hours following the end of the procedure.
Each patient will be asked to fill the visual analogue scale to rate the pain level
post operative pain
Time frame: 72 hours following the end of the procedure.
Each patient will be asked to fill the visual analogue scale to rate the pain level
5 secondary outcomes
Pulpotomy success
Time frame: 3 months after the intervention
Pulpotomy success
Time frame: 6 months after the intervention
Pulpotomy success
Time frame: 9 months after the intervention
Pulpotomy success
Time frame: 12 months after the intervention
Pulpotomy success
Time frame: 18 months after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Results publication: PubMed 32553879Haikal L, Ferraz Dos Santos B, Vu DD, Braniste M, Dabbagh B. Biodentine Pulpotomies on Permanent Traumatized Teeth with Complicated Crown Fractures. J Endod. 2020 Sep;46(9):1204-1209. doi: 10.1016/j.joen.2020.06.003. Epub 2020 Jun 15.
- Individual participant dataSharing planned: No
Related trials for Root Canal Infection
Active, not recruitingObservational study
A Retrospective Cohort Study on the Non-Surgical Treatment of Periapical Inflammatory Lesions With Vitapex Paste
Periapical Periodontitis, Periapical Abscess
Not yet recruitingPhase 1/2
Effect of Temperature Elevation on the Antimicrobial Efficacy of Two Root Canal Irrigants in Primary Root Canal Infections: A Randomized Controlled Clinical Trial
Irreversible Pulpitis
Enrolling by invitationPhase 4
Nanozymes in Endodontics
Apical Periodontitis, Endodontic Disease
Recruiting
One vs Two Visits Root Canal Treatments in Infected Teeth
Apical Periodontitis, Pain
Active, not recruitingObservational study
Lesion Sterilization Tissue Repair and Conventional Pulpectomy in Primary Molars
Pulpitis - Irreversible, Pulp Necroses
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 Abdel Rahman Hashem, phd study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vital pulp therapy in people with Root Canal Infection, run by Ain Shams University at 1 site in Egypt.
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 5 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 22 Jun 2021. 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 Egypt. 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 Ahmed Abdel Rahman m Hashem, phd (226401884, ahmed@endohashem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative pain (time frame: pre-operative). The study lists 6 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 NCT04933955, 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 22 Jun 2021.