Symptomatic Irreversible PulpitisNCT06525844
Regenerative Endodontic Therapy in Cases of Irreversible Pulpitis
A study testing regenerative endodontic therapy using I-PRF and blood clot in people with Symptomatic Irreversible Pulpitis, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
Trial summary
Root canal therapy (RCT) is a classical and effective treatment that is currently utilised in dental practice, offering high success rates for pulp and periapical diseases; however, teeth after RCT are susceptible to altered pulp defence and sensory function, even fractures, as a consequence of pulp loss. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- regenerative endodontic therapy using I-PRF and blood clot
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2024to 1 Oct 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients from both genders with an age range of 18-35 years old.
- Permanent teeth with mature roots with a diagnosis of irreversible pulpitis, with absorption damage to the apex, and the diameter of the apical hole is greater than 1 mm.
- A restorable tooth.
- There is no need to leave space for the final post/core restoration.
- Anterior teeth and premolars with single canal.
- A cooperative and compliant patient.
- Patients not allergic to the drugs and antibiotics which needed to complete treatment.
- No periodontal disease or root cracking.
Who cannot join
- Patients with other serious organ diseases, such as cardiopulmonary, kidney and other major diseases.
- Pregnant women or lactating or expecting within a year.
- Patients with apical cysts.
- Patients with poor cooperation and those who quit the study halfway.
- Patients with periodontitis.
- Patients with dental dysplasia or other oral genetic disorders.
- Patients with dental phobia.
- Patients with mental disorders.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Dr Shahbaz Saqib
Islamabad, ICT, 44080
Shahbaz Saqib, BDS, 3092497829 ext. +92, shahbazbds@outlook.com
Dr Shahbaz Saqib, BDS
About this study
Official title: Clinical and Radiographic Outcomes With the Use of I-PRF in Mature Permanent Teeth With Symptomatic Irreversible Pulpitis : A Randomized Control Trial
Root canal therapy (RCT) is a classical and effective treatment that is currently utilised in dental practice, offering high success rates for pulp and periapical diseases; however, teeth after RCT are susceptible to altered pulp defence and sensory function, even fractures, as a consequence of pulp loss. Furthermore, several studies have highlighted that the actual failure rate of standard root canal treatments performed in general practice is significantly higher than expected . Moreover, these treatments are lengthy and costly and are often subject to retreatment .Inherent in this procedure(rct) is loss of dental hard tissue and subsequent weakening of the treated tooth,making them more prone to fracture. Therefore, less invasive alternative strategies could be used to treat pulpitis, even when irreversible.
Murray et al. proposed the term "Regenerative endodontic treatment (RET)" in 2007, based on a tissue engineering concept (stem cells, biomimetic scaffolds, and bioactive growth factors). The 2016 American Association of Endodontists (AAE) guidelines formally defined RET as a collection of "biologically based procedures designed to replace damaged tooth structures, including dentine and root structures, as well as cells of the pulp-dentine complex"
Read the detailed description
Mature permanent teeth with Irreversible Pulpitis have traditionally been managed with root canal treatment .However this procedure significantly reduces the survival rate of tooth. Acknowledging the inherent healing potential of an infection-free pulp, attempts have been made to use pulpotomy as a treatment modality in permanent teeth with complete root development exhibiting symptoms of irreversible pulpitis, where the radicular pulp is still healthy. Besides, the issues associated with coronal pulpotomy in permanent teeth are uncertainty on the pulpal status at the time of treatment, and lack of predictability. Moreover, there is a dearth of information in the literature that assesses the healing potential of pulp tissue in terms of clinical and radiographic outcomes in mature teeth with irreversible pulpitis.Regenerative endodontic therapy (RET) has attracted increasing attention with the development of tissue engineering. RET applies the concept of tissue engineering to achieve revascularization, innervation, and restoration of odontoblastic layers. Unlike root canal therapy, the disinfected canals are filled with vital tissue in RET rather than biocompatible, nonvital foreign materials. While several studies have explored the potential of pulp regeneration for infected teeth, most studies are limited to the treatment of immature necrotic teeth . For mature permanent teeth, the vital pulp is also of great importance in enhancing the immune system in root canals, promoting dentin deposition under chronic stimuli, and preventing discolouration. However, most of the reports of pulp regeneration in mature teeth are case reports or case series as mature teeth have fewer stem/progenitor cells, have narrower apical pathways for cell migration, and are more difficult to disinfect. Hence, it is of great urgency to develop an improved RET procedure to maximise the regeneration potential of mature teeth and extend the indications of RET.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- regenerative endodontic therapy using I-PRF, blood clot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regenerative endodontic therapy using I-PRFProcedure or surgery
Blood will be taken from medial cubital vein
blood clotProcedure or surgery
Other: BC According to the procedures of regenerative endodontics therapy, BC was made by the way of provoking apical bleeding into root canal.
| Study group | Role | What they receive |
|---|---|---|
| regenerative endodontic therapy with blood clot | Active comparator | In the procedures of regenerative endodontics therapy, K-files were intentionally used to violate the periapical tissues via overinstrumentation up to 2-3mm past the apical foramen to induce bleeding. The adequate blood need to be full with canal space and below the CEJ, then wait for 10-15min to coagulate. Receives: Procedure: blood clot |
| regenerative endodontic therapy with I-PRF | Experimental | In the procedures of regenerative endodontics therapy, K-files were intentionally used to violate the periapical tissues via overinstrumentation up to 2-3mm past the apical foramen to induce bleeding. Only the apex 1/3 of the root canal need to be filled with blood. PRF was injected into the root canal to a level below the CEJ, then wait for 10-15min to coagulate. Receives: Procedure: regenerative endodontic therapy using I-PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of regenerative endodontics therapy
Success: Defined as clinical and radiographic assessment of the teeth. Clinical examination showed absence of clinical signs of pain and soft tissue pathology (e.g. abscess, sinus tract etc.). Radiographic assessment showed the reduction and/or absence of periapical radiolucency.
Measured: 12 months
Secondary outcomes (1)
Change in pulp vitality
Change in pulpal vitality will be assessed through pulpal response to sensitivity tests (cold, hot and electrical test) in teeth treated with RET.
Measured: 1、3、6、12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Aug 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible PulpitisStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahbaz Saqib, Shaheed Zulfiqar Ali Bhutto Medical University
- Investigators
- Dr Shahbaz Saqib, BDS, Principal investigator, Shaheed Zulfiqar Ali Bhutto Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525844
- Sponsor's protocol ID
- SSaqib
- Status last verified
- Aug 2024
- First submitted
- 24 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes With the Use of I-PRF in Mature Permanent Teeth With Symptomatic Irreversible Pulpitis : A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06525844
- Acronym / sponsor ID
- SSaqib
- Conditions
- Symptomatic Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 29 Jul 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.
Root canal therapy (RCT) is a classical and effective treatment that is currently utilised in dental practice, offering high success rates for pulp and periapical diseases; however, teeth after RCT are susceptible to altered pulp defence and sensory function, even fractures, as a consequence of pulp loss. Furthermore, several studies have highlighted that the actual failure rate of standard root canal treatments performed in general practice is significantly higher than expected . Moreover, these treatments are lengthy and costly and are often subject to retreatment .Inherent in this procedure(rct) is loss of dental hard tissue and subsequent weakening of the treated tooth,making them more prone to fracture. Therefore, less invasive alternative strategies could be used to treat pulpitis, even when irreversible.
Murray et al. proposed the term "Regenerative endodontic treatment (RET)" in 2007, based on a tissue engineering concept (stem cells, biomimetic scaffolds, and bioactive growth factors). The 2016 American Association of Endodontists (AAE) guidelines formally defined RET as a collection of "biologically based procedures designed to replace damaged tooth structures, including dentine and root structures, as well as cells of the pulp-dentine complex"
Detailed description
Mature permanent teeth with Irreversible Pulpitis have traditionally been managed with root canal treatment .However this procedure significantly reduces the survival rate of tooth. Acknowledging the inherent healing potential of an infection-free pulp, attempts have been made to use pulpotomy as a treatment modality in permanent teeth with complete root development exhibiting symptoms of irreversible pulpitis, where the radicular pulp is still healthy. Besides, the issues associated with coronal pulpotomy in permanent teeth are uncertainty on the pulpal status at the time of treatment, and lack of predictability. Moreover, there is a dearth of information in the literature that assesses the healing potential of pulp tissue in terms of clinical and radiographic outcomes in mature teeth with irreversible pulpitis.Regenerative endodontic therapy (RET) has attracted increasing attention with the development of tissue engineering. RET applies the concept of tissue engineering to achieve revascularization, innervation, and restoration of odontoblastic layers. Unlike root canal therapy, the disinfected canals are filled with vital tissue in RET rather than biocompatible, nonvital foreign materials. While several studies have explored the potential of pulp regeneration for infected teeth, most studies are limited to the treatment of immature necrotic teeth . For mature permanent teeth, the vital pulp is also of great importance in enhancing the immune system in root canals, promoting dentin deposition under chronic stimuli, and preventing discolouration. However, most of the reports of pulp regeneration in mature teeth are case reports or case series as mature teeth have fewer stem/progenitor cells, have narrower apical pathways for cell migration, and are more difficult to disinfect. Hence, it is of great urgency to develop an improved RET procedure to maximise the regeneration potential of mature teeth and extend the indications of RET.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| regenerative endodontic therapy with blood clot | Active comparator | Procedure: blood clotIn the procedures of regenerative endodontics therapy, K-files were intentionally used to violate the periapical tissues via overinstrumentation up to 2-3mm past the apical foramen to induce bleeding. The adequate blood need to be full with canal space and below the CEJ, then wait for 10-15min to coagulate. |
| regenerative endodontic therapy with I-PRF | Experimental | Procedure: regenerative endodontic therapy using I-PRFIn the procedures of regenerative endodontics therapy, K-files were intentionally used to violate the periapical tissues via overinstrumentation up to 2-3mm past the apical foramen to induce bleeding. Only the apex 1/3 of the root canal need to be filled with blood. PRF was injected into the root canal to a level below the CEJ, then wait for 10-15min to coagulate. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients from both genders with an age range of 18-35 years old.
- Permanent teeth with mature roots with a diagnosis of irreversible pulpitis, with absorption damage to the apex, and the diameter of the apical hole is greater than 1 mm.
- A restorable tooth.
- There is no need to leave space for the final post/core restoration.
- Anterior teeth and premolars with single canal.
Key exclusion criteria (8 listed)
- Patients with other serious organ diseases, such as cardiopulmonary, kidney and other major diseases.
- Pregnant women or lactating or expecting within a year.
- Patients with apical cysts.
- Patients with poor cooperation and those who quit the study halfway.
- Patients with periodontitis.
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 |
|---|---|---|
| regenerative endodontic therapy using I-PRFBlood will be taken from medial cubital vein | Procedure or surgery | regenerative endodontic therapy with I-PRF |
| blood clotOther: BC According to the procedures of regenerative endodontics therapy, BC was made by the way of provoking apical bleeding into root canal. | Procedure or surgery | regenerative endodontic therapy with blood clot |
Primary outcome
Success of regenerative endodontics therapy
Time frame: 12 months
Success: Defined as clinical and radiographic assessment of the teeth. Clinical examination showed absence of clinical signs of pain and soft tissue pathology (e.g. abscess, sinus tract etc.). Radiographic assessment showed the reduction and/or absence of periapical radiolucency.
1 secondary outcome
Change in pulp vitality
Time frame: 1、3、6、12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- 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.
Dr Shahbaz Saqib, BDS principal investigator
Shaheed Zulfiqar Ali Bhutto Medical 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 regenerative endodontic therapy using I-PRF and blood clot in people with Symptomatic Irreversible Pulpitis, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
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 8 inclusion and 8 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 Aug 2024. 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 Pakistan. 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 Dr Shahbaz Saqib, BDS (3092497829 ext. +92, shahbazbds@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of regenerative endodontics therapy (time frame: 12 months). 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 5 Aug 2024.