Diabetic tooth pain study: can a simpler procedure replace root canals?

NCT ID NCT07163975

Disease control Sponsor: Postgraduate Institute of Dental Sciences Rohtak Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study compares two dental procedures—complete pulpotomy and root canal treatment—in 106 adults with type 2 diabetes who have a painful tooth condition called irreversible pulpitis. The goal is to see which treatment is more successful at relieving pain, healing the tooth, and improving quality of life. Participants will be randomly assigned to one of the two treatments and followed for one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: complete pulpotomy (a dental procedure that removes the inflamed pulp and seals the tooth) and root canal treatment
What this could lead to: If successful, this study could show that a simpler, less invasive procedure (pulpotomy) works as well as root canal for diabetic patients with tooth pain, potentially saving more natural tooth structure.
What could go wrong: This is a small, early-stage trial with only 106 participants, so results may not apply to everyone. The success of either treatment depends on individual health factors, and there is always a risk of infection or treatment failure.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 106 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

pulpitis type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Irreversible pulpitis Type 2 diabetes mellitus (T2DM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Diabetic tooth pain study: can a simpler procedure replace root canals?

What the study statuses mean