Endodontically Treated TeethNCT06226870
Outcome of NSRCT Versus VPT in Management of Teeth with Symptomatic Irreversible Pulpitis Associated with Apical Periodontitis
A study testing root canal tretment, biodentin VPT and PRF in people with Endodontically Treated Teeth, run by Minia University at 1 site in Egypt.
Trial summary
Pulpitis is the pulpal inflammation in response to irritants which are either microbial, chemical, or physical (mechanical and thermal) in origin. Clinically, pulpitis is termed as reversible or irreversible, whereas histologically, it is described as acute, chronic or hyperplastic . Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontically Treated Teeth
- What is being tested?
- root canal tretment, biodentin VPT and PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to Apr 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy patients (Category: American society of anesthesiologists class I) of either gender aged from 18-40 years.
- Permanent mature mandibular first molars with a definitive clinical diagnosis of SIP (positive response to pulp sensibility test) with SAP (PAI score ≤ 3)
Who cannot join
- Patients with systemic diseases such as (diabetes, hypertension, etc.…).
- Immunocompromised patients.
- Pregnant women and smokers.
- Patients with a history of antibiotic or analgesics intake within the few days before the intervention and cases with previously initiated endodontic treatment.
- Intraoperatively, where the haemostasis (application of 2.5% sodium hypochlorite pressure pack) could not be achieved within 10 minutes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Vital Pulp Therapy Outcome Versus Root Canal Treatment in Management of Mature Permanent Molars with Irreversible Pulpitis and Apical Periodontitis(A Randomized Double-Blinded Clinical Trial)
Pulpitis is the pulpal inflammation in response to irritants which are either microbial, chemical, or physical (mechanical and thermal) in origin. Clinically, pulpitis is termed as reversible or irreversible, whereas histologically, it is described as acute, chronic or hyperplastic . Pulpitis is considered reversible when the pulp can heal following conservative management . For such cases, a coronal pulpotomy is considered as a definitive treatment option having 78% to 90% of success rate . In irreversible pulpitis (IP), the pulp is not capable of healing, thus it is treated traditionally complete pulpectomy.
Read the detailed description
I- Intervention
- Diagnosis to reach definitive diagnosis of SIP (positive response to pulp sensibility test) associated with SAP (PAI score ≤ 3), a detailed history and clinical examination should be collaborated with the radiographic evidence (CBCT) of apical periodontitis.
- Endodontic procedures
- Anesthetic protocol:
Tooth will be anaesthetized using 3.6 ml of 2% lidocaine with 1:100,000 epinephrine.
Inferior alveolar nerve block (IANB) supplemented by buccal infiltration will be accomplished using a standard aspirating syringe and a 27-G, long needle (C-K ject, CK Dental, Korea).
Access cavity preparation:
After rubber dam isolation, the tooth surface will be cleaned with gauze soaked in 5.25% sodium hypochlorite before the procedure.
All undermined tooth structure and caries will be removed with a diamond bur (komet, komet Dental, Germany) mounted on a high-speed handpiece.
Conventional access cavity will be performed by using round diamond bur (komet, komet Dental, Germany) for initial penetration. While Endo-Z (Prima Dental Group, UK) will be used for wall refinement to establish a straight-line access to canal orifices.
Preparation of the pulp chamber:
Immediately after access cavity preparation, any pulp tissue in the pulp chamber will be eliminated followed by cleansing with full concentration of sodium hypochlorite (6% NaOCl).
NSRCT group
- Patency Root canal patency will be established using a stainless-steel ISO size 10 K file (M. access, Dentsply, Switzerland).
- Working length determination The working length will be determined using an electronic apex locater (Tri Auto-ZX, J Morita, Japan) and re-confirmed by a digital intraoral periapical radiograph.
- Glide path Micro glidepath will be established using a stainless-steel ISO size 10 and 15 K manual files followed by macro glidepath using ProGlider® glide path rotary File.
- Root canal preparation The canals will be instrumented using Pro Taper Next® rotary files mounted on a torque controlled endodontic motor , in a continuous rotation motion, while torque and speed will be adjusted according to manufacturer instructions.
- Irrigation protocol During instrumentation Instrumentation will be supplemented with a copious irrigation of 2 ml of 6% NaOCl between each file and another delivered using a 30-gauge side-vented closed end irrigation neddle.
Final irrigation protocol An alternate use of 10 mL of 6% sodium hypochlorite and 10 mL of 17% EDTA for each canal, with an intermediate rinse with the same volumes of normal saline will be accomplished.
- Root canal obturation All canals will be dried using sterile paper points (ProTaper Next paper points .
Obturation will be done using a single cone technique with a bioceramic sealer .
VPT group All procedures will be carried out according to the guide-lines of the American Association of Endodontists (AAE) in 2021 for vital pulp therapy.
Haemostasis will be achieved with application of a cotton pellet moistened with 2.5% NaOCl for 2 min on which dry cotton pellet will be further placed. If required, the haemostasis will be carried out for another 6 minutes. In circumstances where the haemostasis still will not be achieved, the tooth will be excluded from the study.
Once the bleeding will be controlled, Biodentine will be mixed according to the manufacturer's instructions and will be placed in a 3-mm layer above the pulp tissue using an amalgam carrier and gently packed using a condenser . A layer of light-cure RMGIC will be placed over the pulpotomy agent and light-cured for 20s.
VPT with PRF group All procedures will be carried out according to the guide-lines of the American Association of Endodontists (AAE) in 2021 for vital pulp therapy.
Access cavity preparation and haemostasis will be carried out as mentioned previously, then PRF will be prepared by drawing the required amount of blood into a 10-mL test tube without an anticoagulant and centrifuged immediately using a table top centrifuge machine for 12 min. The resultant product consisted of the following three layers:
- A cellular platelet poor plasma at the top of the tube.
- Fibrin clot (PRF) in the middle of the tube.
- Red blood corpuscles at the bottom of the tube. PRF will be obtained in the form of a membrane by squeezing out the fluids in the fibrin clot.
After that, the PRF membrane will be placed over the amputated pulp by using sterile tweezers. Biodentine will be will be placed in a 3-mm layer above the PRF gently packed using a condenser then a layer of light-cure RMGIC will be placed over the PRF and Biodentine then light-cured for 20s as mentioned in the previous group .
- Permanent restoration For all groups, the access cavity will be sealed with an appropriate post endodontic restoration within one week after root canal filling.
II. Outcome assessment:
Clinical evaluation and radiographic evaluation.
- Conditions
- Endodontically Treated Teeth
- Being tested
- root canal tretment, biodentin VPT, PRF
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root canal tretmentProcedure or surgery
Also called RCT
traditional therapy
biodentin VPTProcedure or surgery
Also called VPT
Alternative therapy
PRFProcedure or surgery
Also called PRF plus VPT
Alternative therapy
| Study group | Role | What they receive |
|---|---|---|
| NSRCT Group | Experimental | Non-surgical root canal therapy Receives: Procedure: root canal tretment |
| VPT Group | Experimental | vital pulp therapy Receives: Procedure: biodentin VPT |
| VPT+PRF Group | Experimental | vital pulp therapy with PRF Receives: Procedure: PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Preoperative and postoperative pain will be recorded on a point numeric rating scale by another operator. The numerical scale of pain is most commonly from 0 to 10, with 0 being "no pain" the lowest value and 10 being "the worst pain imaginable refer to the highest value, the lowest value means better outcome results.
Measured: at 24, 48 and 72-hours
Radiographic evaluation
CBCT will be taken postoperatively to assess the periapical healing based on periapical index ( PAI) score. PAI score is ordinal scale of 5 scores ranging from 1 (healthy) lowest value to 5 (severe periodontitis with exacerbating features) highest value . The lowest value means better outcome.
Measured: at baseline ,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 posted26 Jan 2024
- Study start1 May 2024
- Primary completionJan 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontically Treated TeethStudies of the same condition, open and under way.
- More trials run by Minia 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
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abdelaal Mohamed, Minia University
- Investigators
- Abeer H Mahran, professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226870
- Sponsor's protocol ID
- NSRCT versus VPT
- Status last verified
- Mar 2024
- First submitted
- 17 Jan 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Vital Pulp Therapy Outcome Versus Root Canal Treatment in Management of Mature Permanent Molars with Irreversible Pulpitis and Apical Periodontitis(A Randomized Double-Blinded Clinical Trial)
- ClinicalTrials.gov ID
- NCT06226870
- Acronym / sponsor ID
- NSRCT versus VPT
- Conditions
- Endodontically Treated Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 26 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.
Pulpitis is the pulpal inflammation in response to irritants which are either microbial, chemical, or physical (mechanical and thermal) in origin. Clinically, pulpitis is termed as reversible or irreversible, whereas histologically, it is described as acute, chronic or hyperplastic . Pulpitis is considered reversible when the pulp can heal following conservative management . For such cases, a coronal pulpotomy is considered as a definitive treatment option having 78% to 90% of success rate . In irreversible pulpitis (IP), the pulp is not capable of healing, thus it is treated traditionally complete pulpectomy.
Detailed description
I- Intervention
- Diagnosis to reach definitive diagnosis of SIP (positive response to pulp sensibility test) associated with SAP (PAI score ≤ 3), a detailed history and clinical examination should be collaborated with the radiographic evidence (CBCT) of apical periodontitis.
- Endodontic procedures
- Anesthetic protocol:
Tooth will be anaesthetized using 3.6 ml of 2% lidocaine with 1:100,000 epinephrine.
Inferior alveolar nerve block (IANB) supplemented by buccal infiltration will be accomplished using a standard aspirating syringe and a 27-G, long needle (C-K ject, CK Dental, Korea).
Access cavity preparation:
After rubber dam isolation, the tooth surface will be cleaned with gauze soaked in 5.25% sodium hypochlorite before the procedure.
All undermined tooth structure and caries will be removed with a diamond bur (komet, komet Dental, Germany) mounted on a high-speed handpiece.
Conventional access cavity will be performed by using round diamond bur (komet, komet Dental, Germany) for initial penetration. While Endo-Z (Prima Dental Group, UK) will be used for wall refinement to establish a straight-line access to canal orifices.
Preparation of the pulp chamber:
Immediately after access cavity preparation, any pulp tissue in the pulp chamber will be eliminated followed by cleansing with full concentration of sodium hypochlorite (6% NaOCl).
NSRCT group
- Patency Root canal patency will be established using a stainless-steel ISO size 10 K file (M. access, Dentsply, Switzerland).
- Working length determination The working length will be determined using an electronic apex locater (Tri Auto-ZX, J Morita, Japan) and re-confirmed by a digital intraoral periapical radiograph.
- Glide path Micro glidepath will be established using a stainless-steel ISO size 10 and 15 K manual files followed by macro glidepath using ProGlider® glide path rotary File.
- Root canal preparation The canals will be instrumented using Pro Taper Next® rotary files mounted on a torque controlled endodontic motor , in a continuous rotation motion, while torque and speed will be adjusted according to manufacturer instructions.
- Irrigation protocol During instrumentation Instrumentation will be supplemented with a copious irrigation of 2 ml of 6% NaOCl between each file and another delivered using a 30-gauge side-vented closed end irrigation neddle.
Final irrigation protocol An alternate use of 10 mL of 6% sodium hypochlorite and 10 mL of 17% EDTA for each canal, with an intermediate rinse with the same volumes of normal saline will be accomplished.
- Root canal obturation All canals will be dried using sterile paper points (ProTaper Next paper points .
Obturation will be done using a single cone technique with a bioceramic sealer .
VPT group All procedures will be carried out according to the guide-lines of the American Association of Endodontists (AAE) in 2021 for vital pulp therapy.
Haemostasis will be achieved with application of a cotton pellet moistened with 2.5% NaOCl for 2 min on which dry cotton pellet will be further placed. If required, the haemostasis will be carried out for another 6 minutes. In circumstances where the haemostasis still will not be achieved, the tooth will be excluded from the study.
Once the bleeding will be controlled, Biodentine will be mixed according to the manufacturer's instructions and will be placed in a 3-mm layer above the pulp tissue using an amalgam carrier and gently packed using a condenser . A layer of light-cure RMGIC will be placed over the pulpotomy agent and light-cured for 20s.
VPT with PRF group All procedures will be carried out according to the guide-lines of the American Association of Endodontists (AAE) in 2021 for vital pulp therapy.
Access cavity preparation and haemostasis will be carried out as mentioned previously, then PRF will be prepared by drawing the required amount of blood into a 10-mL test tube without an anticoagulant and centrifuged immediately using a table top centrifuge machine for 12 min. The resultant product consisted of the following three layers:
- A cellular platelet poor plasma at the top of the tube.
- Fibrin clot (PRF) in the middle of the tube.
- Red blood corpuscles at the bottom of the tube. PRF will be obtained in the form of a membrane by squeezing out the fluids in the fibrin clot.
After that, the PRF membrane will be placed over the amputated pulp by using sterile tweezers. Biodentine will be will be placed in a 3-mm layer above the PRF gently packed using a condenser then a layer of light-cure RMGIC will be placed over the PRF and Biodentine then light-cured for 20s as mentioned in the previous group .
- Permanent restoration For all groups, the access cavity will be sealed with an appropriate post endodontic restoration within one week after root canal filling.
II. Outcome assessment:
Clinical evaluation and radiographic evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NSRCT Group | Experimental | Procedure: root canal tretmentNon-surgical root canal therapy |
| VPT Group | Experimental | Procedure: biodentin VPTvital pulp therapy |
| VPT+PRF Group | Experimental | Procedure: PRFvital pulp therapy with PRF |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy patients (Category: American society of anesthesiologists class I) of either gender aged from 18-40 years.
- Permanent mature mandibular first molars with a definitive clinical diagnosis of SIP (positive response to pulp sensibility test) with SAP (PAI score ≤ 3)
Key exclusion criteria (5 listed)
- Patients with systemic diseases such as (diabetes, hypertension, etc.…).
- Immunocompromised patients.
- Pregnant women and smokers.
- Patients with a history of antibiotic or analgesics intake within the few days before the intervention and cases with previously initiated endodontic treatment.
- Intraoperatively, where the haemostasis (application of 2.5% sodium hypochlorite pressure pack) could not be achieved within 10 minutes.
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 |
|---|---|---|
| root canal tretmentAlso: RCTtraditional therapy | Procedure or surgery | NSRCT Group |
| biodentin VPTAlso: VPTAlternative therapy | Procedure or surgery | VPT Group |
| PRFAlso: PRF plus VPTAlternative therapy | Procedure or surgery | VPT+PRF Group |
Primary outcome
Postoperative pain
Time frame: at 24, 48 and 72-hours
Preoperative and postoperative pain will be recorded on a point numeric rating scale by another operator. The numerical scale of pain is most commonly from 0 to 10, with 0 being "no pain" the lowest value and 10 being "the worst pain imaginable refer to the highest value, the lowest value means better outcome results.
Radiographic evaluation
Time frame: at baseline ,6 and 12-months
CBCT will be taken postoperatively to assess the periapical healing based on periapical index ( PAI) score. PAI score is ordinal scale of 5 scores ranging from 1 (healthy) lowest value to 5 (severe periodontitis with exacerbating features) highest value . The lowest value means better outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
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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.
Abeer H Mahran, professor 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 root canal tretment, biodentin VPT and PRF in people with Endodontically Treated Teeth, run by Minia 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 2 inclusion and 5 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 20 Nov 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: at 24, 48 and 72-hours). The study lists 2 primary outcomes in all. 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 20 Nov 2024.