Pulpitis - IrreversibleNCT05902936
Evaluation of Nano Bioactive Glass Combined With i-PRF Scaffold in Vital Pulp Treatments
A study testing Pulpotomy for mature permanent mandibular molars in people with Pulpitis - Irreversible and Apical Periodontitis, run by Cairo University at 1 site in Egypt.
Trial summary
With consideration of the previous studies regarding the properties of i-PRF, it will be used in combination with another bioactive material: (Nano-BAG) versus using of i-PRF only as a pulpotomy material with using a premixed bioceramic putty as a coronal sealing material in both cases, to evaluate if there is a… Read more about this study
- Who is it for?
- Ages 10 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible, Apical Periodontitis
- What is being tested?
- Pulpotomy for mature permanent mandibular molars
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to Mar 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 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- • Patients suffering from symptomatic irreversible pulpitis.
- Tooth should give positive response to cold test
- Heamostatis should be achieved after complete pulpotomy
- Diagnosis is irreversible pulpitis with/without apical periodontitis
- The tooth is restorable and free from advanced periodontal disease
- Tooth is free from cracks or splits
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- Patients should be free from any systemic disease that may affect normal healing and predictable outcomes.
- Patients who will agree to the consent and will commit to follow-up period.
- Patients with mature root (closed apices)
- Teeth with no periapical lesion, resorption or widening.
- Soft tissues around the tooth are normal with no swelling or sinus tract
- Mandibular posterior teeth only will be involved.
Who cannot join
- • Patients with immature root apices.
- Patients with any systemic disease that may affect normal healing.
- Patients with periapical lesions or infections.
- If heamostasis couldn't be achieved within 5-10 minutes
- Pregnant females.
- Patients who could/would not participate in a 6 months follow-up.
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- Patients with fistula or swelling
- Patients with necrotic pulp.
- Patients with old age.
- Badly destructed teeth
- Teeth that are non-restorable
- Teeth that require post and core build up
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of oral and dental medicine - Cairo University
Cairo, 11511
Ahmed Shawky, Professor, 01007577711, ahmed.shawky@gmail.com
About this study
Official title: Short Term Clinical and Radiographic Evaluation of Nano Bioactive Glass Combined With i-PRF Scaffold in Vital Pulp Treatments in Mature Permanent Mandibular Molars: A Triple Blinded "Randomized Controlled Trial"
With consideration of the previous studies regarding the properties of i-PRF, it will be used in combination with another bioactive material: (Nano-BAG) versus using of i-PRF only as a pulpotomy material with using a premixed bioceramic putty as a coronal sealing material in both cases, to evaluate if there is a difference in the success rate of pulpotomy in case of using Nano-BAG in combination with i-PRF
So, in this study the investigators will use Nano-BAG in combination with i-PRF as a material for pulpotomy in cases of mature permanent mandibular molars and compare its outcomes with using i-PRF only and in both cases pulpotomy material will be covered with a layer of premixed bioceramic putty for coronal sealing.
Read the detailed description
The aim of this study is to evaluate the outcome of i-PRF mixed with Nano-bioactive Glass powder and i-PRF alone covered with a layer of premixed bioceramic putty when used as a material for pulpotomy in terms of relieving pain and maintaining the radicular pulp vitality and inducing dentin bridge formation in mature permanent mandibular molars.
Research Question:
Will i-PRF mixed with Nano-BAG and covered with premixed bioceramic putty gives similar results in relieving pain , conservation of the radicular pulp vitality and dentin bridge formation compared with i-PRF alone covered with premixed bioceramic putty when using it as a material for pulpotomy in mature permanent mandibular molars?
Interventions:
A- Intervention for each group
a- General operative procedures
- Eligible patients will be randomized in equal proportions between the two groups.
Patients of the two groups will be subjected to:
- Diagnosis using diagnostic chart (appendix A) and selected according to inclusion and exclusion criteria
- Comprehensive clinical examination and understanding of patients' chief complaint and needs.
- Standard preoperative digital x-ray for all patients.
B- Intra operative procedures: (For both groups) Before anesthesia, surfaces of the teeth will be cleaned to be free of debris, calculus and plaque. Teeth will first be dried and isolated with cotton rolls and a tooth paste will be applied on the buccal face of the crown as an interface media. An electric pulp tester (EPT) probe will be placed on the sound coronal third of the labial surface and the responses will be recorded before starting the treatment. The contra lateral tooth will be tested first for comparison and then the subjected tooth will be checked.
The procedures will be performed under local anesthesia with Lidocaine 2% and adrenaline 1/100,000. Teeth will be isolated with rubber dam.
All carious tissue and old restoration (if present) will be removed with a diamond stone size 1 in a high speed hand piece with coolant , once the pulp is exposed the diamond stone will be changed and another sterile one will be used for complete deroofing of the pulp chamber. Then a sharp sterile excavator will be used for amputation of the coronal pulp tissue to the level of the root canal orifices.
Haemostasis will be achieved by pressing sterile cotton pellets soaked with sterile saline and damped into the cavity for 5-10 minutes over the pulp stumps (If haemostasis cannot be achieved after 10 mins, the tooth should undergo root canal treatment)
Care should be taken to minimize the time elapsed between coronal pulp amputation and placement of pulpotomy agent. The teeth will be then divided into two groups depending on the pulpotomy agents. I-PRF will be prepared according to Choukroun's technique by drawing a whole blood sample from the median cubital vein into a 10 ml plain test tubes (Non-citrated) to prevent blood coagulation then it will be centrifuged immediately using a table top centrifuge at 700 rpm for 3 mins The whole blood sample that will be obtained consists of three layers: the top most layer of acellular platelet poor plasma, the middle layer of platelet rich fibrin, and the bottom most layer of red blood corpuscles. The upper yellow fluid liquid (i-PRF) will be collected as close as possible to the layer of red blood cell.
Group A (the control group) :
After control of bleeding in teeth allocated to the control group i-PRF is to be injected first. The i-PRF will be injected into the root canal to a level 3 mm below the cementoenamel junction (CEJ).
Group B (In the intervention group):
After control of bleeding in teeth allocated to the intervention group, i-PRF is to be mixed with Nano-BAG powder to a putty consistency and injected into the root canal to a level 3 mm below the cementoenamel junction (CEJ), then a layer of premixed bioceramic putty is to be added for coronal sealing.
Coronal Sealing:
After a period of 10-15-minutes is allowed for coagulation, the coronal sealing material will be applied. The premixed bioceramic putty is dispensed on a sterile glass slab using a flat sided sterile plastic instrument. The material is applied over the coagulated scaffold in both groups using a dedicated carrier (MAP one) The material is adapted over the scaffold using light pressure adaptation with a sterile micro-brush of suitable size.
Final restoration:
A thin layer of resin-modified glass ionomer cement (RMGIC) to be applied directly over the coronal seal. Composite Resin material is to be used as a final restoration.
- Conditions
- Pulpitis - Irreversible, Apical Periodontitis
- Being tested
- Pulpotomy for mature permanent mandibular molars
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulpotomy for mature permanent mandibular molarsProcedure or surgery
Also called Vital pulp therapy
Performing pulpotomy for mature teeth that involves removal of the coronal pulp tissue that is diseased or inflammed followed by placement of a biocompatible material with the intent of maintaining the vitality of the remaining radicular pulp tissue.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | After control of bleeding in teeth allocated to the control group i-PRF is to be injected first. The i-PRF will be injected into the root canal to a level 3 mm below the cementoenamel junction (CEJ) then a layer of premixed bioceramic putty is to be added for coronal sealing. Receives: Procedure: Pulpotomy for mature permanent mandibular molars |
| Intervention group | Active comparator | After control of bleeding in teeth allocated to the intervention group, i-PRF is to be mixed with Nano bioactive glass (Nano-BAG) powder to a putty consistency and injected into the root canal to a level 3 mm below the cementoenamel junction (CEJ), then a layer of premixed bioceramic putty is to be added for coronal sealing. Receives: Procedure: Pulpotomy for mature permanent mandibular molars |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measurement (change is being assessed)
Measurement of the change in pain intensity using Visual Analogue Scale from 0 to 10 where higher scores mean higher pain intensity
Measured: After 24 hours and up to 7 days for postoperative pain evaluation using Visual Analogue Scale.
Secondary outcomes (2)
Radiographic assesment (change is being assessed)
Radiographic assesment of dentin bridge formation whether it is present or absent
Measured: at 1 month , 3 months and 6 months
Tooth sensibility (change is being assessed)
Tooth sensibility will be assessed using Thermal (cold) test
Measured: at 1 month , 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Mar 2023
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpitis - IrreversibleStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Nabil Naguib, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902936
- Sponsor's protocol ID
- ENDO3-7-2
- Status last verified
- Jun 2023
- First submitted
- 22 May 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Clinical and Radiographic Evaluation of Nano Bioactive Glass Combined With i-PRF Scaffold in Vital Pulp Treatments in Mature Permanent Mandibular Molars: A Triple Blinded "Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT05902936
- Acronym / sponsor ID
- ENDO3-7-2
- Conditions
- Pulpitis - Irreversible, Apical Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 15 Jun 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.
With consideration of the previous studies regarding the properties of i-PRF, it will be used in combination with another bioactive material: (Nano-BAG) versus using of i-PRF only as a pulpotomy material with using a premixed bioceramic putty as a coronal sealing material in both cases, to evaluate if there is a difference in the success rate of pulpotomy in case of using Nano-BAG in combination with i-PRF
So, in this study the investigators will use Nano-BAG in combination with i-PRF as a material for pulpotomy in cases of mature permanent mandibular molars and compare its outcomes with using i-PRF only and in both cases pulpotomy material will be covered with a layer of premixed bioceramic putty for coronal sealing.
Detailed description
The aim of this study is to evaluate the outcome of i-PRF mixed with Nano-bioactive Glass powder and i-PRF alone covered with a layer of premixed bioceramic putty when used as a material for pulpotomy in terms of relieving pain and maintaining the radicular pulp vitality and inducing dentin bridge formation in mature permanent mandibular molars.
Research Question:
Will i-PRF mixed with Nano-BAG and covered with premixed bioceramic putty gives similar results in relieving pain , conservation of the radicular pulp vitality and dentin bridge formation compared with i-PRF alone covered with premixed bioceramic putty when using it as a material for pulpotomy in mature permanent mandibular molars?
Interventions:
A- Intervention for each group
a- General operative procedures
- Eligible patients will be randomized in equal proportions between the two groups.
Patients of the two groups will be subjected to:
- Diagnosis using diagnostic chart (appendix A) and selected according to inclusion and exclusion criteria
- Comprehensive clinical examination and understanding of patients' chief complaint and needs.
- Standard preoperative digital x-ray for all patients.
B- Intra operative procedures: (For both groups) Before anesthesia, surfaces of the teeth will be cleaned to be free of debris, calculus and plaque. Teeth will first be dried and isolated with cotton rolls and a tooth paste will be applied on the buccal face of the crown as an interface media. An electric pulp tester (EPT) probe will be placed on the sound coronal third of the labial surface and the responses will be recorded before starting the treatment. The contra lateral tooth will be tested first for comparison and then the subjected tooth will be checked.
The procedures will be performed under local anesthesia with Lidocaine 2% and adrenaline 1/100,000. Teeth will be isolated with rubber dam.
All carious tissue and old restoration (if present) will be removed with a diamond stone size 1 in a high speed hand piece with coolant , once the pulp is exposed the diamond stone will be changed and another sterile one will be used for complete deroofing of the pulp chamber. Then a sharp sterile excavator will be used for amputation of the coronal pulp tissue to the level of the root canal orifices.
Haemostasis will be achieved by pressing sterile cotton pellets soaked with sterile saline and damped into the cavity for 5-10 minutes over the pulp stumps (If haemostasis cannot be achieved after 10 mins, the tooth should undergo root canal treatment)
Care should be taken to minimize the time elapsed between coronal pulp amputation and placement of pulpotomy agent. The teeth will be then divided into two groups depending on the pulpotomy agents. I-PRF will be prepared according to Choukroun's technique by drawing a whole blood sample from the median cubital vein into a 10 ml plain test tubes (Non-citrated) to prevent blood coagulation then it will be centrifuged immediately using a table top centrifuge at 700 rpm for 3 mins The whole blood sample that will be obtained consists of three layers: the top most layer of acellular platelet poor plasma, the middle layer of platelet rich fibrin, and the bottom most layer of red blood corpuscles. The upper yellow fluid liquid (i-PRF) will be collected as close as possible to the layer of red blood cell.
Group A (the control group) :
After control of bleeding in teeth allocated to the control group i-PRF is to be injected first. The i-PRF will be injected into the root canal to a level 3 mm below the cementoenamel junction (CEJ).
Group B (In the intervention group):
After control of bleeding in teeth allocated to the intervention group, i-PRF is to be mixed with Nano-BAG powder to a putty consistency and injected into the root canal to a level 3 mm below the cementoenamel junction (CEJ), then a layer of premixed bioceramic putty is to be added for coronal sealing.
Coronal Sealing:
After a period of 10-15-minutes is allowed for coagulation, the coronal sealing material will be applied. The premixed bioceramic putty is dispensed on a sterile glass slab using a flat sided sterile plastic instrument. The material is applied over the coagulated scaffold in both groups using a dedicated carrier (MAP one) The material is adapted over the scaffold using light pressure adaptation with a sterile micro-brush of suitable size.
Final restoration:
A thin layer of resin-modified glass ionomer cement (RMGIC) to be applied directly over the coronal seal. Composite Resin material is to be used as a final restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Procedure: Pulpotomy for mature permanent mandibular molarsAfter control of bleeding in teeth allocated to the control group i-PRF is to be injected first. The i-PRF will be injected into the root canal to a level 3 mm below the cementoenamel junction (CEJ) then a layer of premixed bioceramic putty is to be added for coronal sealing. |
| Intervention group | Active comparator | Procedure: Pulpotomy for mature permanent mandibular molarsAfter control of bleeding in teeth allocated to the intervention group, i-PRF is to be mixed with Nano bioactive glass (Nano-BAG) powder to a putty consistency and injected into the root canal to a level 3 mm below the cementoenamel junction (CEJ), then a layer of premixed bioceramic putty is to be added for coronal sealing. |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- • Patients suffering from symptomatic irreversible pulpitis.
Key exclusion criteria (12 listed)
- • Patients with immature root apices.
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 |
|---|---|---|
| Pulpotomy for mature permanent mandibular molarsAlso: Vital pulp therapyPerforming pulpotomy for mature teeth that involves removal of the coronal pulp tissue that is diseased or inflammed followed by placement of a biocompatible material with the intent of maintaining the vitality of the remaining radicular pulp tissue. | Procedure or surgery | Control group, Intervention group |
Primary outcome
Pain measurement (change is being assessed)
Time frame: After 24 hours and up to 7 days for postoperative pain evaluation using Visual Analogue Scale.
Measurement of the change in pain intensity using Visual Analogue Scale from 0 to 10 where higher scores mean higher pain intensity
2 secondary outcomes
Radiographic assesment (change is being assessed)
Time frame: at 1 month , 3 months and 6 months
Tooth sensibility (change is being assessed)
Time frame: at 1 month , 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulpotomy for mature permanent mandibular molars in people with Pulpitis - Irreversible and Apical Periodontitis, run by Cairo 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 12 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 15 Jun 2023. 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 Geraldine Ahmed, Professor (01226322227, geraldine.ahmed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain measurement (change is being assessed) (time frame: After 24 hours and up to 7 days for postoperative pain evaluation using Visual Analogue Scale.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2023.