Vital Pulp TherapyNCT06232941
Comparative Evaluation of Three Pulpotomy Agents for Permanent Mature Molars With Irreversible Pulpitis
A study testing Full pulpotomy procedure in people with Vital Pulp Therapy, run by Ain Shams University.
Trial summary
Statement of the problem: Accurate pulpal diagnosis is essential for decision making between vital pulp therapy and root canal treatment. Clinical and radiographic examinations do not correctly reflect the histological state of the pulp and consequently its ability to heal. Read more about this study
- Who is it for?
- Ages 16 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vital Pulp Therapy
- What is being tested?
- Full pulpotomy procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Dec 2025
- 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 16 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants with permanent molars considered as having clinical signs and symptoms consistent with a diagnosis of irreversible pulpitis if they presented with the following chief complaint:
- Intermittent or spontaneous, sharp or dull, localized, diffuse, or referred pain.
- Rapid exposure to dramatic temperature changes elicited heightened and --prolonged episodes of pain even after the thermal stimulus has been removed.
- Participants without signs and symptoms of apical periodontitis
- Periodontally healthy permanent molars
- Systemically healthy patients without any history of long-acting NSAIDs intake in the past one week will be included to eliminate any confounding factors.
Who cannot join
- Non-restorable teeth with cracks or subgingival caries, associated sinus or swelling, immature roots, periapical rarefaction (PAI score ≥ 3).
- Poor periodontal support.
- Negative response to pulp sensibility tests.
- Diabetic, immune-compromised, pregnant patients
- Patient had a positive history of antibiotic use in the past 1 month or required antibiotic prophylaxis
- The tooth was previously accessed
- The tooth had an inflamed pulp in which bleeding could not be controlled within 10 minutes.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Evaluation of Three Calcium Silicate Based Materials as Pulpotomy Agents for Permanent Mature Molars With Irreversible Pulpitis: Randomized Clinical Trial
Statement of the problem:
Accurate pulpal diagnosis is essential for decision making between vital pulp therapy and root canal treatment. Clinical and radiographic examinations do not correctly reflect the histological state of the pulp and consequently its ability to heal. Also, despite the various advantages of using MTA as a pulp capping agent, it has several drawbacks.
Read more
Aim of the study:
The aim of the study is to compare two types of calcium silicate-based materials to MTA in permanent mature molars diagnosed with irreversible pulpitis regarding the following parameters; level of inflammatory biomarker level, clinical and radiographic outcomes.
Materials and methods:
Thirty-six patients with mature permanent molars exhibiting signs and symptoms indicative of irreversible pulpitis will be enrolled. A careful periodontal treatment and standardized operative procedure will be followed for all participants. Gingival crevicular fluid samples will be obtained before any local anesthetics' administration, followed by isolation of teeth with a dental dam and removal of caries. Pulpotomy will be performed using sterile round bur till level of orifices and then haemostasis will be achieved using sodium hypochlorite. At this point, patients will be randomly divided into three groups of 12 depending on the type of calcium silicate-based material used. Later, resin modified glass ionomer will be applied, etching, bonding and placement of composite as the permanent restoration. Follow up clinically and radiographically will be done.
Read the detailed description
For many centuries, there has been a closely held belief that any vital mature permanent tooth diagnosed with irreversible pulpitis will require root canal treatment. The reason for such treatment modality, is the high success rate reaching 100% if performed with high standards(1). However, many studies have demonstrated that root canal therapy can be time-consuming(2), necessitate multiple visits(3), be expensive for both the patient and the dentist, and can increase the likelihood that the tooth will fracture because of the loss of tooth structure(2).
On the other hand, vital pulp therapy (VPT) provides many advantages compared to root canal treatment. For example; it maintains the proprioceptive sensation of the tooth, biological immune response from the retained pulp tissue can prevent infection of the apical area, regenerative and repair potential of the pulp is retained, structural integrity of the tooth is maintained, lowering the risk of fracture and there is a notable decrease in pain and discomfort for the patient (4).
More conservative VPT like pulpotomy was limited to immature teeth with mechanical, carious, or traumatic pulp exposure who don't exhibit any periapical disease. In such cases, the goal has been to ensure completion of root formation (apexogenesis)(5). However, the European Society of Endodontology (ESE) and the American Association of Endodontists (AAE) recently released position statements stating that "pre-treatment diagnosis of irreversible pulpitis is not necessarily an indication for pulpectomy", ushering in a new era for minimally invasive VPT in mature permanent teeth Although, several studies (8,14)found that using mineral trioxide aggregate (MTA) for VPT of cariously exposed permanent teeth with irreversible pulpitis resulted in high clinical success rates. Clinically, there have been various complaints against MTA. There have been reports of difficult handling, prolonged setting time, expensive cost, and probable tooth discoloration By far, the most popular and widely utilized materials in the endodontic therapy are calcium silicate cements. Odontocem (Australian Dental Manufacturing, Brisbane, Australia) is a calcium silicate-based technology containing 0.2% of the low steroid triamcinolone acetonide and has outstanding biocompatibility, handling properties and least amount of staining potential. It can be utilised as a dentine substitute for lining deep cavities. Odontocem is proposed to provide antibacterial activity due to its initial high PH and pain relief due to the presence of a potent steroid (16).
Another calcium silicate material that is also recently introduced in the market is NeoPutty (Avalon Biomed Inc., Bradenton, USA). NeoPutty is premixed format of tricalcium silicate-based material (Bioceramic). It's composed of tantalum oxide, tricalcium silicate, calcium aluminate, dicalcium silicate, tricalcium aluminate, and calcium sulfate(17). Guillen et al 2022 (17)compared the cytocompatibility of NeoPutty to NeoMTA Plus and MTA Angelus and concluded that all three materials provided adequate cytocompatibility and preliminary evidence that NeoPutty can be used as pulp capping agent in VPT.
- Conditions
- Vital Pulp Therapy
- Being tested
- Full pulpotomy procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full pulpotomy procedureProcedure or surgery
Also called vital pulp therapy
vital pulp therapy for molars with irreversible pulpitis instead of doing root canal treatment
| Study group | Role | What they receive |
|---|---|---|
| Odontocem pulpotomy agent | Experimental | calcium silicate-based technology containing 0.2% of the low steroid triamcinolone acetonide and has outstanding biocompatibility, handling properties and least amount of staining potential Receives: Procedure: Full pulpotomy procedure |
| NeoPutty bioceramic | Active comparator | premixed format of tricalcium silicate-based material (Bioceramic). It's composed of tantalum oxide, tricalcium silicate, calcium aluminate, dicalcium silicate, tricalcium aluminate, and calcium sulfate Receives: Procedure: Full pulpotomy procedure |
| Mineral Trioxide Aggregate material | Active comparator | hydrophilic and biocompatible endodontic biomaterial, capable of stimulating healing and osteogenesis Receives: Procedure: Full pulpotomy procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory marker level (matrix metalloproteinase 9) for assessment of pulpotomy success.
Inflammation biomarker which is matrix metalloproteinase 9 (diagnostic) may be provided by molecules expressed during the cascade of tissue inflammation. Also, studies have demonstrated that the presence of protein markers or biomarkers in gingival crevicular fluid (GCF) can represent pulpal events
Measured: Inflammatory biomarker level in gingival crevicular fluid using ELISA kit at the day of the procedure and then after 1 week .
Secondary outcomes (1)
Radiographic evaluation
Using CBCT, periapical index scale will be used to assess presence or absence of radiolucency associated with the tested teeth Radiographically (baseline, -6 and -12 months) concerning any changes in tooth and surrounding structures.
Measured: baseline, after 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital Pulp TherapyStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232941
- Sponsor's protocol ID
- FDASU-REC1261
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Three Calcium Silicate Based Materials as Pulpotomy Agents for Permanent Mature Molars With Irreversible Pulpitis: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06232941
- Acronym / sponsor ID
- FDASU-REC1261
- Conditions
- Vital Pulp Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 31 Jan 2024 (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.
Statement of the problem:
Accurate pulpal diagnosis is essential for decision making between vital pulp therapy and root canal treatment. Clinical and radiographic examinations do not correctly reflect the histological state of the pulp and consequently its ability to heal. Also, despite the various advantages of using MTA as a pulp capping agent, it has several drawbacks.
Aim of the study:
The aim of the study is to compare two types of calcium silicate-based materials to MTA in permanent mature molars diagnosed with irreversible pulpitis regarding the following parameters; level of inflammatory biomarker level, clinical and radiographic outcomes.
Materials and methods:
Thirty-six patients with mature permanent molars exhibiting signs and symptoms indicative of irreversible pulpitis will be enrolled. A careful periodontal treatment and standardized operative procedure will be followed for all participants. Gingival crevicular fluid samples will be obtained before any local anesthetics' administration, followed by isolation of teeth with a dental dam and removal of caries. Pulpotomy will be performed using sterile round bur till level of orifices and then haemostasis will be achieved using sodium hypochlorite. At this point, patients will be randomly divided into three groups of 12 depending on the type of calcium silicate-based material used. Later, resin modified glass ionomer will be applied, etching, bonding and placement of composite as the permanent restoration. Follow up clinically and radiographically will be done.
Detailed description
For many centuries, there has been a closely held belief that any vital mature permanent tooth diagnosed with irreversible pulpitis will require root canal treatment. The reason for such treatment modality, is the high success rate reaching 100% if performed with high standards(1). However, many studies have demonstrated that root canal therapy can be time-consuming(2), necessitate multiple visits(3), be expensive for both the patient and the dentist, and can increase the likelihood that the tooth will fracture because of the loss of tooth structure(2).
On the other hand, vital pulp therapy (VPT) provides many advantages compared to root canal treatment. For example; it maintains the proprioceptive sensation of the tooth, biological immune response from the retained pulp tissue can prevent infection of the apical area, regenerative and repair potential of the pulp is retained, structural integrity of the tooth is maintained, lowering the risk of fracture and there is a notable decrease in pain and discomfort for the patient (4).
More conservative VPT like pulpotomy was limited to immature teeth with mechanical, carious, or traumatic pulp exposure who don't exhibit any periapical disease. In such cases, the goal has been to ensure completion of root formation (apexogenesis)(5). However, the European Society of Endodontology (ESE) and the American Association of Endodontists (AAE) recently released position statements stating that "pre-treatment diagnosis of irreversible pulpitis is not necessarily an indication for pulpectomy", ushering in a new era for minimally invasive VPT in mature permanent teeth Although, several studies (8,14)found that using mineral trioxide aggregate (MTA) for VPT of cariously exposed permanent teeth with irreversible pulpitis resulted in high clinical success rates. Clinically, there have been various complaints against MTA. There have been reports of difficult handling, prolonged setting time, expensive cost, and probable tooth discoloration By far, the most popular and widely utilized materials in the endodontic therapy are calcium silicate cements. Odontocem (Australian Dental Manufacturing, Brisbane, Australia) is a calcium silicate-based technology containing 0.2% of the low steroid triamcinolone acetonide and has outstanding biocompatibility, handling properties and least amount of staining potential. It can be utilised as a dentine substitute for lining deep cavities. Odontocem is proposed to provide antibacterial activity due to its initial high PH and pain relief due to the presence of a potent steroid (16).
Another calcium silicate material that is also recently introduced in the market is NeoPutty (Avalon Biomed Inc., Bradenton, USA). NeoPutty is premixed format of tricalcium silicate-based material (Bioceramic). It's composed of tantalum oxide, tricalcium silicate, calcium aluminate, dicalcium silicate, tricalcium aluminate, and calcium sulfate(17). Guillen et al 2022 (17)compared the cytocompatibility of NeoPutty to NeoMTA Plus and MTA Angelus and concluded that all three materials provided adequate cytocompatibility and preliminary evidence that NeoPutty can be used as pulp capping agent in VPT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Odontocem pulpotomy agent | Experimental | Procedure: Full pulpotomy procedurecalcium silicate-based technology containing 0.2% of the low steroid triamcinolone acetonide and has outstanding biocompatibility, handling properties and least amount of staining potential |
| NeoPutty bioceramic | Active comparator | Procedure: Full pulpotomy procedurepremixed format of tricalcium silicate-based material (Bioceramic). It's composed of tantalum oxide, tricalcium silicate, calcium aluminate, dicalcium silicate, tricalcium aluminate, and calcium sulfate |
| Mineral Trioxide Aggregate material | Active comparator | Procedure: Full pulpotomy procedurehydrophilic and biocompatible endodontic biomaterial, capable of stimulating healing and osteogenesis |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Participants with permanent molars considered as having clinical signs and symptoms consistent with a diagnosis of irreversible pulpitis if they presented with the following chief complaint:
- Intermittent or spontaneous, sharp or dull, localized, diffuse, or referred pain.
- Rapid exposure to dramatic temperature changes elicited heightened and --prolonged episodes of pain even after the thermal stimulus has been removed.
- Participants without signs and symptoms of apical periodontitis
- Periodontally healthy permanent molars
Key exclusion criteria (7 listed)
- Non-restorable teeth with cracks or subgingival caries, associated sinus or swelling, immature roots, periapical rarefaction (PAI score ≥ 3).
- Poor periodontal support.
- Negative response to pulp sensibility tests.
- Diabetic, immune-compromised, pregnant patients
- Patient had a positive history of antibiotic use in the past 1 month or required antibiotic prophylaxis
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 |
|---|---|---|
| Full pulpotomy procedureAlso: vital pulp therapyvital pulp therapy for molars with irreversible pulpitis instead of doing root canal treatment | Procedure or surgery | Mineral Trioxide Aggregate material, NeoPutty bioceramic, Odontocem pulpotomy agent |
Primary outcome
Inflammatory marker level (matrix metalloproteinase 9) for assessment of pulpotomy success.
Time frame: Inflammatory biomarker level in gingival crevicular fluid using ELISA kit at the day of the procedure and then after 1 week .
Inflammation biomarker which is matrix metalloproteinase 9 (diagnostic) may be provided by molecules expressed during the cascade of tissue inflammation. Also, studies have demonstrated that the presence of protein markers or biomarkers in gingival crevicular fluid (GCF) can represent pulpal events
1 secondary outcome
Radiographic evaluation
Time frame: baseline, after 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Vital Pulp Therapy
Not yet recruitingObservational study
Age-Related Inflammatory Proteins as Indicators of Vital Pulp Therapy Outcomes
Vital Pulp Therapy
Not yet recruiting
Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
Reversible Pulpitis, Dental Caries
Recruiting
Laser-Assisted vs Conventional Total Pulpotomy in Symptomatic Irreversible Pulpitis
Symptomatic Irreversible Pulpitis and Post Operative Pain
Not yet recruitingObservational study
Prognostic Value of Pulpal Blood pH and Oxygen Saturation in Vital Pulp Therapy: Determination of Clinically Relevant Thresholds in a Prospective Clinical Study
Vital Pulp Therapies, pH
Active, not recruitingObservational study
Clinical Evaluation of Discoloration Induced by Root Canal Treatment in Vital and Devital Teeth
Tooth Discoloration Following Root Canal Treatment, Tooth Discoloration
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.
Questions about this trial
What is this clinical trial studying?
A study testing Full pulpotomy procedure in people with Vital Pulp Therapy, run by Ain Shams 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 6 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 31 Jan 2024. 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 Nourhan M Yehia, assistant lecturer (+2011146656546, nourhan.yehia@miuegypt.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory marker level (matrix metalloproteinase 9) for assessment of pulpotomy success. (time frame: Inflammatory biomarker level in gingival crevicular fluid using ELISA kit at the day of the procedure and then after 1 week .). 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 31 Jan 2024.