Apical PeriodontitisNCT06179433
Outcome of Regenerative Endodontic Procedure and Root Canal Treatment for the Management of Apical Periodontitis
A study testing Root canal treatment and Regenerative endodontic procedure in people with Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Background Root canal therapy is the primary treatment of choice for necrotic mature teeth with periapical lesions (PRLs), which does not restore the tooth's vitality. Provided that injectable platelet-rich fibrin (i-PRF) has shown promising results in regenerative medicine as a novel platelet concentration, the… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Root canal treatment and Regenerative endodontic procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2023to 1 Sep 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Consenting healthy adults with age range of 18- 40 years
- Patient presenting with atleast one permanent mandibular molar with necrotic pulp (negative response to sensibility testing by cold and electric pulp test).
- Radiographic evidence of periapical radiolucency of strictly endodontic origin score ≥3 according to the classification of Ørstavik et al (diagnosis of asymptomatic apical periodontitis or chronic apical abscess) with lesion size ≤ 5mm
Who cannot join
- Non-restorable teeth or tooth with severe coronal defect where rubber dam isolation is not possible
- Teeth with root fractures or pathological root resorptions
- Teeth with endodontic- periodontal communications
- Patients with generalized chronic periodontitis or periodontal pocket more than 3 mm
- Teeth with previous root canal treatment
- Severe root canal curvatures
- Pregnant or lactating women
- Patients with a history of systemic diseases and/or receiving medications that affect healing or blood coagulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome of Regenerative Endodontic Procedure in Comparison to Nonsurgical Root Canal Treatment for the Management of Necrotic Mature Molar Teeth With Periapical Lesions - A Randomized Controlled Trial
Background Root canal therapy is the primary treatment of choice for necrotic mature teeth with periapical lesions (PRLs), which does not restore the tooth's vitality. Provided that injectable platelet-rich fibrin (i-PRF) has shown promising results in regenerative medicine as a novel platelet concentration, the purpose of this study is to ascertain whether i-PRF, as opposed to blood clot (BC), can serve as a biological scaffold, thereby expanding the indications for regenerative endodontic procedures (REPs) in mature teeth.
Novelty There is no study available that has evaluated the outcome of REP in the necrotic mature mandibular molars with periapical lesions. Furthermore, the efficacy of novel i-PRF as a scaffold in REPs remains to be explored.
Read more
Objectives To evaluate and compare the outcome of REPs in comparison to conventional RCT in necrotic mature molars with PRLs and to evaluate the efficacy of i-PRF and BC in REP as a scaffold. Secondary objective is to evaluate pain for first postoperative week and subjective responses to pulp sensibility tests at 12 months follow-up.
Method 120 patients presenting with necrotic pulp and periapical lesions will be randomly allotted to one of the three groups - REP using i-PRF or BC or RCT group. Comparative evaluation of outcome of REP and RCT will be performed at 12-months follow-up.
Read the detailed description
Regenerative endodontic procedures (REPs) are biologically based procedures used to replace damaged structures such as dentin and root structures, as well as pulp-dentin complex cells (4, 5). Majority of studies have focused on treating immature necrotic teeth with the REP approach in order to preserve root development and regenerate functional pulp tissue (6-9). REPs have recently been proposed as an alternative approach to treating necrotic mature permanent teeth with apical periodontitis due to their promising results (10-12). However, it did face a few challenges, including fewer stem cells, narrower apical foramina for induction of blood and stem cell migration, and difficulty disinfecting the root completely (11).
The most common scaffold for revascularization involves creation of blood clot (BC) by inducing bleeding from the periapical tissue using an endodontic file. However, blood clots are a meagre source of growth factors, and the precise method required to control the rate and volume of bleeding is still uncertain (13-15). Second-generation platelet concentrate, or platelet-rich fibrin (PRF), is a type of natural autologous fibrin matrix containing trapped leukocytes and platelets to ensure a sustained release of cytokines and growth factors. However, their applicability is restricted because of its solid nature. The development of a liquid form of PRF (injectable PRF) in 2016 was made possible by the use of gentle or low speed centrifugation, which has benefits for bone, periodontal cartilage, and pulp tissue regeneration (16,17). After application, injectable PRF (i-PRF) gradually changes into a growth factor-rich PRF clot that releases growth factors steadily over the course of 10 to 14 days (16).
To the best of our knowledge, no study has been conducted that utilized i-PRF as a scaffold for REPs in mature teeth. Therefore, the aim of this trial is to evaluate and compare the efficacy of i-PRF and blood clot as scaffolds in REPs in comparison to nonsurgical root canal treatment in necrotic mature molars with periapical lesions (PRLs).
- Conditions
- Apical Periodontitis
- Being tested
- Root canal treatment, Regenerative endodontic procedure
- Keywords
- regenerative endodontics, root canal treatment
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal treatmentProcedure or surgery
Two-visit root canal treatment will be performed.
Regenerative endodontic procedureProcedure or surgery
Regenerative endodontic procedure with i-PRF and blood clot induction will be performed.
| Study group | Role | What they receive |
|---|---|---|
| root canal treatment | Experimental | Two-visit root canal treatment will be performed. Receives: Procedure: Root canal treatment |
| REP with I-PRF | Active comparator | The first appointment will be performed similar to the conventional RCT group. in the second appointment, i-PRF will be prepared by collecting venous blood and centrifugate at 700rpm for 3 minutes. i-PRF will be injected into canal followed by a bioceramic material. Receives: Procedure: Regenerative endodontic procedure |
| REP with blood clot | Active comparator | The first appointment will be performed similar to the conventional RCT group. In the second appointment, after anesthetizing with 3% mepivacine, the canals will be re-entered and irrigated well with 17% EDTA. Bleeding will be induced by inserting sterile #25 K-file into the 2-3 mm beyond the apical foramen into periapical tissues. Receives: Procedure: Regenerative endodontic procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical and radiographic success
Clinical and radiographic success of REPs in comparison to conventional RCT in necrotic mature molars with PRLs
Measured: 12 month follow-up.
Secondary outcomes (2)
postoperative pain
Postoperative pain at first week after procedure
Measured: 1 week
Pulp sensibility response
Subjective response to pulp sensibility test
Measured: 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 posted21 Dec 2023
- Study start1 May 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jigyasa 1 duhan, MDS, Principal investigator, PGIDS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179433
- Sponsor's protocol ID
- Dr.Jigyasa Duhan
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Regenerative Endodontic Procedure in Comparison to Nonsurgical Root Canal Treatment for the Management of Necrotic Mature Molar Teeth With Periapical Lesions - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06179433
- Acronym / sponsor ID
- Dr.Jigyasa Duhan
- Conditions
- Apical Periodontitis
- Keywords
- regenerative endodontics, root canal treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 21 Dec 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.
Background Root canal therapy is the primary treatment of choice for necrotic mature teeth with periapical lesions (PRLs), which does not restore the tooth's vitality. Provided that injectable platelet-rich fibrin (i-PRF) has shown promising results in regenerative medicine as a novel platelet concentration, the purpose of this study is to ascertain whether i-PRF, as opposed to blood clot (BC), can serve as a biological scaffold, thereby expanding the indications for regenerative endodontic procedures (REPs) in mature teeth.
Novelty There is no study available that has evaluated the outcome of REP in the necrotic mature mandibular molars with periapical lesions. Furthermore, the efficacy of novel i-PRF as a scaffold in REPs remains to be explored.
Objectives To evaluate and compare the outcome of REPs in comparison to conventional RCT in necrotic mature molars with PRLs and to evaluate the efficacy of i-PRF and BC in REP as a scaffold. Secondary objective is to evaluate pain for first postoperative week and subjective responses to pulp sensibility tests at 12 months follow-up.
Method 120 patients presenting with necrotic pulp and periapical lesions will be randomly allotted to one of the three groups - REP using i-PRF or BC or RCT group. Comparative evaluation of outcome of REP and RCT will be performed at 12-months follow-up.
Detailed description
Regenerative endodontic procedures (REPs) are biologically based procedures used to replace damaged structures such as dentin and root structures, as well as pulp-dentin complex cells (4, 5). Majority of studies have focused on treating immature necrotic teeth with the REP approach in order to preserve root development and regenerate functional pulp tissue (6-9). REPs have recently been proposed as an alternative approach to treating necrotic mature permanent teeth with apical periodontitis due to their promising results (10-12). However, it did face a few challenges, including fewer stem cells, narrower apical foramina for induction of blood and stem cell migration, and difficulty disinfecting the root completely (11).
The most common scaffold for revascularization involves creation of blood clot (BC) by inducing bleeding from the periapical tissue using an endodontic file. However, blood clots are a meagre source of growth factors, and the precise method required to control the rate and volume of bleeding is still uncertain (13-15). Second-generation platelet concentrate, or platelet-rich fibrin (PRF), is a type of natural autologous fibrin matrix containing trapped leukocytes and platelets to ensure a sustained release of cytokines and growth factors. However, their applicability is restricted because of its solid nature. The development of a liquid form of PRF (injectable PRF) in 2016 was made possible by the use of gentle or low speed centrifugation, which has benefits for bone, periodontal cartilage, and pulp tissue regeneration (16,17). After application, injectable PRF (i-PRF) gradually changes into a growth factor-rich PRF clot that releases growth factors steadily over the course of 10 to 14 days (16).
To the best of our knowledge, no study has been conducted that utilized i-PRF as a scaffold for REPs in mature teeth. Therefore, the aim of this trial is to evaluate and compare the efficacy of i-PRF and blood clot as scaffolds in REPs in comparison to nonsurgical root canal treatment in necrotic mature molars with periapical lesions (PRLs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| root canal treatment | Experimental | Procedure: Root canal treatmentTwo-visit root canal treatment will be performed. |
| REP with I-PRF | Active comparator | Procedure: Regenerative endodontic procedureThe first appointment will be performed similar to the conventional RCT group. in the second appointment, i-PRF will be prepared by collecting venous blood and centrifugate at 700rpm for 3 minutes. i-PRF will be injected into canal followed by a bioceramic material. |
| REP with blood clot | Active comparator | Procedure: Regenerative endodontic procedureThe first appointment will be performed similar to the conventional RCT group. In the second appointment, after anesthetizing with 3% mepivacine, the canals will be re-entered and irrigated well with 17% EDTA. Bleeding will be induced by inserting sterile #25 K-file into the 2-3 mm beyond the apical foramen into periapical tissues. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Consenting healthy adults with age range of 18- 40 years
- Patient presenting with atleast one permanent mandibular molar with necrotic pulp (negative response to sensibility testing by cold and electric pulp test).
- Radiographic evidence of periapical radiolucency of strictly endodontic origin score ≥3 according to the classification of Ørstavik et al (diagnosis of asymptomatic apical periodontitis or chronic apical abscess) with lesion size ≤ 5mm
Key exclusion criteria (8 listed)
- Non-restorable teeth or tooth with severe coronal defect where rubber dam isolation is not possible
- Teeth with root fractures or pathological root resorptions
- Teeth with endodontic- periodontal communications
- Patients with generalized chronic periodontitis or periodontal pocket more than 3 mm
- Teeth with previous root canal treatment
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 treatmentTwo-visit root canal treatment will be performed. | Procedure or surgery | root canal treatment |
| Regenerative endodontic procedureRegenerative endodontic procedure with i-PRF and blood clot induction will be performed. | Procedure or surgery | REP with I-PRF, REP with blood clot |
Primary outcome
clinical and radiographic success
Time frame: 12 month follow-up.
Clinical and radiographic success of REPs in comparison to conventional RCT in necrotic mature molars with PRLs
2 secondary outcomes
postoperative pain
Time frame: 1 week
Pulp sensibility response
Time frame: 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 21 Dec 2023.
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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.
jigyasa 1 duhan, MDS principal investigator
PGIDS
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 treatment and Regenerative endodontic procedure in people with Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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 3 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 21 Dec 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 India. 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?
clinical and radiographic success (time frame: 12 month follow-up.). 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 21 Dec 2023.