Irreversible PulpitisNCT06586775
Outcome of Complete Pulpotomy in Healthy and Type 2 Diabetic Patients in Permanent Teeth With Irreversible Pulpitis
A study testing Pulpotomy in people with Irreversible Pulpitis and Diabetes Mellitus, Type 2, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Endodontic research on the effects of DM on pulp tissues is scarce. Diabetic human and animal histological research demonstrated a decreased reparatory response in the pulp, resulting in chronic pulp inflammation and reduced dentin bridge formation. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis, Diabetes Mellitus, Type 2, Healthy
- What is being tested?
- Pulpotomy
- 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 Aug 2023to 1 Feb 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus with HbA1c > 6.5% > 7% with no other co-morbidities.
- Age and gender matched healthy patients
- Age between 35 - 70 years.
- Mature permanent teeth with clinical and radiographic signs and symptoms indicative of irreversible pulpitis (PAI score ≤2)
- Tooth showing positive response to pulp sensibility testing.
Who cannot join
- Patients with immunocompromised diseases or systematic diseases (other than diabetes mellitus)
- Smokers, pregnant and lactating women
- Teeth with immature roots or retained deciduous tooth.
- Bleeding could not be controlled in ≥8 minutes.
- Tooth with signs and symptoms of apical periodontitis.
- Tooth with probing depth more than 4mm.
- Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis and/or analgesic usage in past 3 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome of Complete Pulpotomy in Healthy and Type 2 Diabetic Patients in Permanent Teeth With Irreversible Pulpitis - A Preliminary Prospective Interventional Study.
Endodontic research on the effects of DM on pulp tissues is scarce. Diabetic human and animal histological research demonstrated a decreased reparatory response in the pulp, resulting in chronic pulp inflammation and reduced dentin bridge formation. To date, there is no human clinical trial examining the impact of diabetes mellitus on teeth with irreversible pulpitis. As a result of the paucity of data in the literature, there is a clinical dilemma whether to recommend vital pulp therapy techniques or root canal treatment in diabetic patients with irreversible pulpitis.
To the best of our knowledge, no prospective study has evaluated the outcome of complete pulpotomy in T2DM patients and healthy controls with irreversible pulpitis. The aim of this preliminary study is to compare and evaluate the success rates of pulpotomy in healthy and type 2 diabetes mellitus patients in mature permanent teeth presenting with clinical symptoms of irreversible pulpitis.
Read the detailed description
Introduction:
Endodontic disease can affect both the pulp and the periapical areas of the tooth. The resultant immune-pathological reaction could be acute or chronic inflammation, depending on the ability of pulp and periapical tissue to respond to and recover from the noxious stimuli. T2DM has been recognized as a crucial factor affecting the pulpal and periapical tissues, in terms of susceptibility, progression, and healing. Endodontic research on the effects of DM on pulp tissues is scarce. Diabetic human and animal histological research demonstrated a decreased reparatory response in the pulp, resulting in chronic pulp inflammation and reduced dentin bridge formation. To date, there is no human clinical trial examining the impact of diabetes mellitus on teeth with irreversible pulpitis. As a result of the paucity of data in the literature, there is a clinical dilemma whether to recommend vital pulp therapy techniques or root canal treatment in diabetic patients with irreversible pulpitis.
To the best of our knowledge, no prospective study has evaluated the outcome of complete pulpotomy in T2DM patients and healthy controls with irreversible pulpitis. The aim of this preliminary study is to compare and evaluate the success rates of pulpotomy in healthy and type 2 diabetes mellitus patients in mature permanent teeth presenting with clinical symptoms of irreversible pulpitis.
AIM The aim of this study is to evaluate and compare the outcome of complete pulpotomy in healthy and type 2 diabetes mellitus patients presenting with clinical and radiographic signs and symptoms indicative of irreversible pulpitis.
OBJECTIVES
- To evaluate the clinical and radiographic success of pulpotomy with clinical and radiographic signs indicative of irreversible pulpitis.
- To investigate the effect of treatment outcome on glycated hemoglobin (HbA1c) in type 2 diabetic patients with irreversible pulpitis.
RESEARCH QUESTION Does the complete pulpotomy in type 2 diabetes mellitus patients is as effective as complete pulpotomy in healthy patients in mature permanent teeth presenting with clinical and radiographic signs and symptoms indicative of irreversible pulpitis? PICO
- P (Population) - Diabetic patients with mature permanent teeth with clinical and radiographic signs of irreversible pulpitis
- I (Intervention) - Complete pulpotomy in diabetic patients
- C (Comparison) - Complete pulpotomy in healthy patients
- O (Outcome) - Assessment of clinical and radiographic success at 3, 6 and 12 months follow-up.
- Conditions
- Irreversible Pulpitis, Diabetes Mellitus, Type 2, Healthy
- Being tested
- Pulpotomy
- Keywords
- Pulpotomy, irreversible pulpitis, Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpotomyProcedure or surgery
complete pulpotomy
| Study group | Role | What they receive |
|---|---|---|
| diabetic group | Experimental | complete pulpotomy will be performed in teeth with irreversible pulpitis in diabetic patients. Receives: Procedure: Pulpotomy |
| Healthy group | Active comparator | complete pulpotomy will be performed in teeth with irreversible pulpitis in systemically healthy patients. Receives: Procedure: Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment outcome
Outcome of complete pulpotomy in healthy and diabetic patients through clinical and radiographic findings.
Measured: 6 and 12 month follow-up.
Secondary outcomes (1)
1) Effect of treatment on glycated haemoglobin levels in diabetic patients
Changes in glycated haemoglobin levels
Measured: 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Aug 2023
- Primary completion31 Oct 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr.keerthana G, MDS, Principal investigator, PGIDS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586775
- Sponsor's protocol ID
- Keerthana ENDO
- Status last verified
- Nov 2023
- First submitted
- 6 Dec 2023
- Last updated
- 30 Sep 2026
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Complete Pulpotomy in Healthy and Type 2 Diabetic Patients in Permanent Teeth With Irreversible Pulpitis - A Preliminary Prospective Interventional Study.
- ClinicalTrials.gov ID
- NCT06586775
- Acronym / sponsor ID
- Keerthana ENDO
- Conditions
- Irreversible Pulpitis, Diabetes Mellitus, Type 2, Healthy
- Keywords
- Pulpotomy, irreversible pulpitis, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 19 Sep 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.
Endodontic research on the effects of DM on pulp tissues is scarce. Diabetic human and animal histological research demonstrated a decreased reparatory response in the pulp, resulting in chronic pulp inflammation and reduced dentin bridge formation. To date, there is no human clinical trial examining the impact of diabetes mellitus on teeth with irreversible pulpitis. As a result of the paucity of data in the literature, there is a clinical dilemma whether to recommend vital pulp therapy techniques or root canal treatment in diabetic patients with irreversible pulpitis.
To the best of our knowledge, no prospective study has evaluated the outcome of complete pulpotomy in T2DM patients and healthy controls with irreversible pulpitis. The aim of this preliminary study is to compare and evaluate the success rates of pulpotomy in healthy and type 2 diabetes mellitus patients in mature permanent teeth presenting with clinical symptoms of irreversible pulpitis.
Detailed description
Introduction:
Endodontic disease can affect both the pulp and the periapical areas of the tooth. The resultant immune-pathological reaction could be acute or chronic inflammation, depending on the ability of pulp and periapical tissue to respond to and recover from the noxious stimuli. T2DM has been recognized as a crucial factor affecting the pulpal and periapical tissues, in terms of susceptibility, progression, and healing. Endodontic research on the effects of DM on pulp tissues is scarce. Diabetic human and animal histological research demonstrated a decreased reparatory response in the pulp, resulting in chronic pulp inflammation and reduced dentin bridge formation. To date, there is no human clinical trial examining the impact of diabetes mellitus on teeth with irreversible pulpitis. As a result of the paucity of data in the literature, there is a clinical dilemma whether to recommend vital pulp therapy techniques or root canal treatment in diabetic patients with irreversible pulpitis.
To the best of our knowledge, no prospective study has evaluated the outcome of complete pulpotomy in T2DM patients and healthy controls with irreversible pulpitis. The aim of this preliminary study is to compare and evaluate the success rates of pulpotomy in healthy and type 2 diabetes mellitus patients in mature permanent teeth presenting with clinical symptoms of irreversible pulpitis.
AIM The aim of this study is to evaluate and compare the outcome of complete pulpotomy in healthy and type 2 diabetes mellitus patients presenting with clinical and radiographic signs and symptoms indicative of irreversible pulpitis.
OBJECTIVES
- To evaluate the clinical and radiographic success of pulpotomy with clinical and radiographic signs indicative of irreversible pulpitis.
- To investigate the effect of treatment outcome on glycated hemoglobin (HbA1c) in type 2 diabetic patients with irreversible pulpitis.
RESEARCH QUESTION Does the complete pulpotomy in type 2 diabetes mellitus patients is as effective as complete pulpotomy in healthy patients in mature permanent teeth presenting with clinical and radiographic signs and symptoms indicative of irreversible pulpitis? PICO
- P (Population) - Diabetic patients with mature permanent teeth with clinical and radiographic signs of irreversible pulpitis
- I (Intervention) - Complete pulpotomy in diabetic patients
- C (Comparison) - Complete pulpotomy in healthy patients
- O (Outcome) - Assessment of clinical and radiographic success at 3, 6 and 12 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetic group | Experimental | Procedure: Pulpotomycomplete pulpotomy will be performed in teeth with irreversible pulpitis in diabetic patients. |
| Healthy group | Active comparator | Procedure: Pulpotomycomplete pulpotomy will be performed in teeth with irreversible pulpitis in systemically healthy patients. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes mellitus with HbA1c > 6.5% > 7% with no other co-morbidities.
- Age and gender matched healthy patients
- Age between 35 - 70 years.
- Mature permanent teeth with clinical and radiographic signs and symptoms indicative of irreversible pulpitis (PAI score ≤2)
- Tooth showing positive response to pulp sensibility testing.
Key exclusion criteria (7 listed)
- Patients with immunocompromised diseases or systematic diseases (other than diabetes mellitus)
- Smokers, pregnant and lactating women
- Teeth with immature roots or retained deciduous tooth.
- Bleeding could not be controlled in ≥8 minutes.
- Tooth with signs and symptoms of apical 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 |
|---|---|---|
| Pulpotomycomplete pulpotomy | Procedure or surgery | Healthy group, diabetic group |
Primary outcome
Treatment outcome
Time frame: 6 and 12 month follow-up.
Outcome of complete pulpotomy in healthy and diabetic patients through clinical and radiographic findings.
1 secondary outcome
1) Effect of treatment on glycated haemoglobin levels in diabetic patients
Time frame: 3 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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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.keerthana G, 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 Pulpotomy in people with Irreversible Pulpitis and Diabetes Mellitus, Type 2, 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 5 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: finished, as of the sponsor's last update on 30 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment outcome (time frame: 6 and 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 30 Sep 2026.