New dental material could save more teeth from root canals

NCT ID NCT07302438

Disease control Sponsor: All India Institute of Medical Sciences Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new material made from treated dentin and calcium silicate for treating deep cavities that have reached the tooth's nerve. The goal is to see if it can keep the nerve healthy better than the current standard material. Fifty-six people aged 14 to 35 with deep cavities and reversible pulpitis will be randomly assigned to receive either the new material or the standard one during a miniature pulpotomy. Success will be measured by nerve response to cold and other signs of healing over six months.

What this could mean

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

Active substance: Calcium silicate-doped treated dentin matrix
What this could lead to: If it works, this could provide a better material for preserving tooth nerve health after deep cavity treatment, reducing the need for more invasive procedures.
What could go wrong: This is a small, early-stage trial with only 56 participants, so results may not apply broadly. The new material may not perform better than the standard treatment.

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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 56 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 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

14 to 35 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * The healthy participants (ASA 1 and 2), between ages 14 - 35 years, reporting to AIIMS Nagpur from within a 100 kms radius with carious pulp exposure in mature permanent teeth and with the following clinical and radiographic features will be included in the study: I. Clinical features 1. The clinical diagnosis of reversible pulpitis characterized by mild pain (on Numerical Rating Scale 11) that goes away within a couple of seconds following the removal of the stimulus (113) 2. Positive response to pulp sensibility tests. II. Radiographic features 1. Normal periapical tissues \[Periapical index (PAI) score ≤2\](114) 2. The presence of carious lesion with radiolucency penetrating three-fourths (deep caries) or the entire (extremely deep caries) dentin thickness Exclusion Criteria: * The patients with the following clinical and radiographic features will be excluded from the study: I. Clinical features 1. A history of spontaneous unprovoked toothache, pain on percussion, a sinus tract, compromised periodontal status (periodontal pockets \> 4mm), excessive mobility, crack 2. Profuse hemorrhage from exposure site (\>5 minutes) 3. The presence of serous or purulent exudates from the exposure site. 4. Teeth that have experienced traumatic occlusion, non-carious lesions, developmental defects etc. II. Radiographic features 1. The evidence of internal or external resorption, or the calcification of the pulp chamber or canals or presence of condensing osteitis. 2. The presence of radiolucency in the furcation or periapical regions.

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Conditions

The condition(s) this trial relates to.

dental caries dentin caries pulpitis

As listed by the trial registrant

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

Deep carious lesions Reversible pulpitis

How to take part

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

The places running it

2 sites. 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.

New dental material could save more teeth from root canals

What the study statuses mean