Type 2 Diabetes Mellitus (T2DM)NCT07163975
Complete Pulpotomy and Root Canal Treatment Patients With Irreversible Pulpitis With Type 2 Diabetes Mellitus
A study testing complete pulpotomy and Root canal treatment in people with Type 2 Diabetes Mellitus (T2DM) and Irreversible Pulpitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
there is limited endodontic research on the effects of DM on pulp tissues. Diabetic human and animal histological research have demonstrated decreased wound repair, chronic pulp inflammation and reduced dentin bridge formation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Irreversible Pulpitis
- What is being tested?
- complete pulpotomy and Root canal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2025to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus defined by HbA1c levels 6.5% - 8% OR FPG ≥126 mg/dL OR 2-hour plasma glucose ≥200 mg/dL during an OGTT OR A random plasma glucose of 200 mg/dL or higher in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis
- Age between 18 - 70 years.
- Permanent mandibular posterior teeth with clinical and radiographic signs and symptoms indicative of irreversible pulpitis (PAI score ≤2)
- Tooth showing positive response to pulp sensibility testing with no tenderness on percussion.
- BMI<30 Kg/m2
Who cannot join
- Patients with immunocompromised diseases or chronic kidney disease
- Smokers, pregnant and lactating women
- Teeth with immature roots or retained deciduous tooth.
- Bleeding could not be controlled in ≥5 minutes.
- Tooth with signs and symptoms of apical periodontitis.
- Teeth with procedural errors, cracks, fractured teeth
Show all 9Show fewer
- 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.
- Patients taking drugs that affect bone metabolism such as immune- suppressants, SSRIs, bisphosphonates, hormone replacement therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
PGIDS Rohtak
Rohtak, Haryana, 124001
Jigyasa Duhan, MDS, +91 9896270449, prashitiduhan@rediffmail.com
Anmol Jain, +91 9599724799, drjain.anmol@gmail.com
About this study
Official title: Success of Complete Pulpotomy and Root Canal Treatment and Quality of Life in Patients With Symptomatic Irreversible Pulpitis With Type 2 Diabetes Mellitus: A Randomized Clinical Trial
there is limited endodontic research on the effects of DM on pulp tissues. Diabetic human and animal histological research have demonstrated decreased wound repair, chronic pulp inflammation and reduced dentin bridge formation. To date, no human clinical trial has examined the impact of diabetes mellitus on teeth with irreversible pulpitis. Due to the paucity of data in the literature, there is a clinical dilemma whether to recommend root canal therapy or vital pulp therapy in diabetic patients with irreversible pulpitis.
To the best of our knowledge, no prospective study has evaluated the outcome of complete pulpotomy versus root canal treatment in T2DM patients with irreversible pulpitis. The aim of this study is to compare and evaluate the success rates of pulpotomy and root canal treatment in type 2 diabetes mellitus patients in mature permanent teeth presenting with clinical symptoms of irreversible pulpitis.
Read the detailed description
Rationale: - Preservation of pulp vitality is a critical factor in long-term tooth survival. In extremely deep carious lesion with symptomatic irreversible pulpitis, vital pulp therapy procedures in the form of complete pulpotomy is a more conservative treatment strategy, based on the premise that a biologically active material placed in direct contact with the pulp wound can determine the pulpal response and result in the development of a reparative hard tissue bridge to preserve pulp vitality. Scientific literature indicates that type 2 diabetes mellitus has a detrimental effect on the wound healing capacity of dental pulp, however lacks evidence in clinical studies. to the best of our knowledge no study has been done till date comparing the outcome of complete pulpotomy and root canal treatment in patients with type 2 diabetes mellitus with clinical signs of irreversible pulpitis.
Aim- To compare the outcome of complete pulpotomy and root canal treatment in mandibular permanent posterior teeth with clinical signs indicative of irreversible pulpitis in patients with type 2 diabetes mellitus
Objectives-
- To evaluate the clinical and radiographic success of complete pulpotomy in type 2 diabetic patients in permanent mandibular posterior teeth with clinical signs indicative of irreversible pulpitis.
- To evaluate the clinical and radiographic success of root canal treatment in type 2 diabetic patients mandibular permanent posterior teeth with clinical signs indicative of irreversible pulpitis.
Population - Permanent mandibular posterior teeth with diagnosis of symptomatic irreversible pulpitis in patients with Type 2 Diabetes Mellitus.
Intervention/Treatment- complete pulpotomy
Comparator- Root canal treatment
Outcome- success of complete pulpotomy versus root canal treatment based on clinical and radiographic findings at 3, 6 and 12 months secondary outcome: assessment of quality of life 1 week, 6 and 12 months post treatment.
Time frame - 1 year
- Being tested
- complete pulpotomy, Root canal treatment
- Keywords
- pulpotomy, type 2 Diabetes Mellitus, irreversible pulpitis
- 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.
complete pulpotomyProcedure or surgery
the exposed pulp tissue will be amputated using fresh sterile large round diamond bur in a high-speed hand-piece under water coolant to the level of canal orifices. The pulp wound will be irrigated with 3% NaOCl. For hemostasis, sterile cotton soaked in 3% NaOCl will be placed over the pulpal wound for 2 minutes, repeated for up to 5 min if required. Root canal therapy will be initiated in cases in which haemostasis is not achieved within 5 minutes. After hemostasis, MTA will be placed in thickness of 2 to 3 mm over the pulp exposure site using a carrier. This will be followed by application of a layer of light-cure RMGIC and light-curing for 20 sec. The tooth then will be restored using composite resin following etch and rinse technique.
Root canal treatmentProcedure or surgery
RCT will be performed in single visit. Root canal orifices will be explored using a DG 16 probe. A size 10 or 15 K-file will be passively inserted into the coronal two- thirds of the canal to verify a smooth glide path.
Coronal enlargement will be done using Gates-Glidden drills. Working length will be determined with the help of electronic apex locator and will be confirmed radiographically. Canals will be prepared using the crown down technique with NiTi rotary instruments. The master apical file (MAF) size for each canal will be selected to be three sizes larger than the initial apical binding file at the WL. 5ml of 5.25% sodium hypochlorite using a 30-gauge side-vented needle will be used for optimal irrigation after each instrument.
After completion of canal instrumentation, the canals will be irrigated with 5.0 ml of 17% ethylene-diamine-tetra acetic acid for 1 minute followed by a final irrigation with 5.0 ml of 5.25% sodium hypochlorite. Canals will be dried with
| Study group | Role | What they receive |
|---|---|---|
| complete pulpotomy | Experimental | complete pulpotomy will be performed in teeth with irreversible pulpitis in diabetic patients. Receives: Procedure: complete pulpotomy |
| Root Canal Treatment | Active comparator | root canal treatment will be performed in teeth with irreversible pulpitis in diabetic patients. Receives: Procedure: Root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical success
Clinical success criteria No history of spontaneous pain or discomfort except for the initial days after treatment. No tenderness to palpation or percussion and the tooth is functional. Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract.
Measured: 12 months
radiographic success
Radiographic success criteria No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2
Measured: 12 months
Secondary outcomes (1)
quality of life assessment
OHRQoL assessment: OHIP-14 questionnare will be used to assess the quality of life. OHIP- 14 developed by Slade is a well-validated and reliable tool to assess OHRQoL. It consists of questionnaire in seven dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. It will be scored using a Lickert scale: never=0; hardly ever=1; occasionally=2; fairly often=3; very often=4. Total score will be calculated ranging from 0-56, with higher score denoting the worst At the follow-up visits (1 week, 6 months, and 1 year), the patients will be reporting their responses after receiving the treatment by selecting from the following 3 options: the treatment will be improving the situation, the treatment will be worsening the situation, and no change will be being noticed
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 May 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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
- Participant
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jigyasa Duhan, MDS, Principal investigator, PGIDS Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163975
- Sponsor's protocol ID
- Anmol Jain
- Status last verified
- Apr 2025
- First submitted
- 25 Aug 2025
- Last updated
- 9 Sep 2025
- 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 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success of Complete Pulpotomy and Root Canal Treatment and Quality of Life in Patients With Symptomatic Irreversible Pulpitis With Type 2 Diabetes Mellitus: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07163975
- Acronym / sponsor ID
- Anmol Jain
- Keywords
- pulpotomy, type 2 Diabetes Mellitus, irreversible pulpitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 9 Sep 2025 (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.
there is limited endodontic research on the effects of DM on pulp tissues. Diabetic human and animal histological research have demonstrated decreased wound repair, chronic pulp inflammation and reduced dentin bridge formation. To date, no human clinical trial has examined the impact of diabetes mellitus on teeth with irreversible pulpitis. Due to the paucity of data in the literature, there is a clinical dilemma whether to recommend root canal therapy or vital pulp therapy in diabetic patients with irreversible pulpitis.
To the best of our knowledge, no prospective study has evaluated the outcome of complete pulpotomy versus root canal treatment in T2DM patients with irreversible pulpitis. The aim of this study is to compare and evaluate the success rates of pulpotomy and root canal treatment in type 2 diabetes mellitus patients in mature permanent teeth presenting with clinical symptoms of irreversible pulpitis.
Detailed description
Rationale: - Preservation of pulp vitality is a critical factor in long-term tooth survival. In extremely deep carious lesion with symptomatic irreversible pulpitis, vital pulp therapy procedures in the form of complete pulpotomy is a more conservative treatment strategy, based on the premise that a biologically active material placed in direct contact with the pulp wound can determine the pulpal response and result in the development of a reparative hard tissue bridge to preserve pulp vitality. Scientific literature indicates that type 2 diabetes mellitus has a detrimental effect on the wound healing capacity of dental pulp, however lacks evidence in clinical studies. to the best of our knowledge no study has been done till date comparing the outcome of complete pulpotomy and root canal treatment in patients with type 2 diabetes mellitus with clinical signs of irreversible pulpitis.
Aim- To compare the outcome of complete pulpotomy and root canal treatment in mandibular permanent posterior teeth with clinical signs indicative of irreversible pulpitis in patients with type 2 diabetes mellitus
Objectives-
- To evaluate the clinical and radiographic success of complete pulpotomy in type 2 diabetic patients in permanent mandibular posterior teeth with clinical signs indicative of irreversible pulpitis.
- To evaluate the clinical and radiographic success of root canal treatment in type 2 diabetic patients mandibular permanent posterior teeth with clinical signs indicative of irreversible pulpitis.
Population - Permanent mandibular posterior teeth with diagnosis of symptomatic irreversible pulpitis in patients with Type 2 Diabetes Mellitus.
Intervention/Treatment- complete pulpotomy
Comparator- Root canal treatment
Outcome- success of complete pulpotomy versus root canal treatment based on clinical and radiographic findings at 3, 6 and 12 months secondary outcome: assessment of quality of life 1 week, 6 and 12 months post treatment.
Time frame - 1 year
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complete pulpotomy | Experimental | Procedure: complete pulpotomycomplete pulpotomy will be performed in teeth with irreversible pulpitis in diabetic patients. |
| Root Canal Treatment | Active comparator | Procedure: Root canal treatmentroot canal treatment will be performed in teeth with irreversible pulpitis in diabetic patients. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes mellitus defined by HbA1c levels 6.5% - 8% OR FPG ≥126 mg/dL OR 2-hour plasma glucose ≥200 mg/dL during an OGTT OR A random plasma glucose of 200 mg/dL or higher in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis
- Age between 18 - 70 years.
- Permanent mandibular posterior teeth with clinical and radiographic signs and symptoms indicative of irreversible pulpitis (PAI score ≤2)
- Tooth showing positive response to pulp sensibility testing with no tenderness on percussion.
- BMI<30 Kg/m2
Key exclusion criteria (9 listed)
- Patients with immunocompromised diseases or chronic kidney disease
- Smokers, pregnant and lactating women
- Teeth with immature roots or retained deciduous tooth.
- Bleeding could not be controlled in ≥5 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 |
|---|---|---|
| complete pulpotomythe exposed pulp tissue will be amputated using fresh sterile large round diamond bur in a high-speed hand-piece under water coolant to the level of canal orifices. The pulp wound will be irrigated with 3% NaOCl. For hemostasis, sterile cotton soaked in 3% NaOCl will be placed over the pulpal wound for 2 minutes, repeated for up to 5 min if required. Root canal therapy will be initiated in cases in which haemostasis is not achieved within 5 minutes. After hemostasis, MTA will be placed in thickness of 2 to 3 mm over the pulp exposure site using a carrier. This will be followed by application of a layer of light-cure RMGIC and light-curing for 20 sec. The tooth then will be restored using composite resin following etch and rinse technique. | Procedure or surgery | complete pulpotomy |
| Root canal treatmentRCT will be performed in single visit. Root canal orifices will be explored using a DG 16 probe. A size 10 or 15 K-file will be passively inserted into the coronal two- thirds of the canal to verify a smooth glide path. Coronal enlargement will be done using Gates-Glidden drills. Working length will be determined with the help of electronic apex locator and will be confirmed radiographically. Canals will be prepared using the crown down technique with NiTi rotary instruments. The master apical file (MAF) size for each canal will be selected to be three sizes larger than the initial apical binding file at the WL. 5ml of 5.25% sodium hypochlorite using a 30-gauge side-vented needle will be used for optimal irrigation after each instrument. After completion of canal instrumentation, the canals will be irrigated with 5.0 ml of 17% ethylene-diamine-tetra acetic acid for 1 minute followed by a final irrigation with 5.0 ml of 5.25% sodium hypochlorite. Canals will be dried with | Procedure or surgery | Root Canal Treatment |
Primary outcome
clinical success
Time frame: 12 months
Clinical success criteria No history of spontaneous pain or discomfort except for the initial days after treatment. No tenderness to palpation or percussion and the tooth is functional. Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract.
radiographic success
Time frame: 12 months
Radiographic success criteria No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2
1 secondary outcome
quality of life assessment
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
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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.
Jigyasa Duhan, MDS principal investigator
PGIDS Rohtak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing complete pulpotomy and Root canal treatment in people with Type 2 Diabetes Mellitus (T2DM) and Irreversible Pulpitis, 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 9 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: looking for participants now, as of the sponsor's last update on 9 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jigyasa Duhan, MDS (+91 9896270449, prashitiduhan@rediffmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical success (time frame: 12 months). 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 9 Sep 2025.