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Irreversible PulpitisIPRNCT07391124

In Vivo Pulp Thermal Changes During Different Slenderization Techniques

A study testing High-Speed Air-Driven Drill (Airotor and Bur) and Orthodontic IPR Kit (Oscillating System) in people with Irreversible Pulpitis and Reversible Pulpitis, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this study is to learn about the temperature rise inside the living part of a tooth (the pulp) during different ways of removing a small amount of enamel (the hard outer layer of the tooth), a procedure called Interproximal Enamel Reduction (IPR). Read more about this study

Who is it for?
Ages 12 to 25 years
What is being tested?
High-Speed Air-Driven Drill (Airotor and Bur) and Orthodontic IPR Kit (Oscillating System)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 sitePakistan
Study dates
29 Sep 2024to 29 Oct 2026
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 12 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Participants 12 to 25 years of age.
  • Participants undergoing orthodontic treatment requiring extraction of the teeth being studied (Incisors or Premolars).
  • Selected tooth must be intact (no decay, large fillings, or fractures).
  • Tooth must test vital (alive and healthy) prior to the procedure.
  • Tooth must have healthy surrounding gum tissue.

Who cannot join

  • Teeth that are non-vital (dead), have root canal treatment, or signs of irreversible pulpitis.
  • Teeth with existing large or deep restorations (fillings) or crowns/veneers.
  • Teeth that have undergone any previous IPR or stripping procedure.
  • Teeth with significant developmental enamel defects (e.g., severe hypoplasia or fluorosis).
  • Participants with severe systemic diseases (e.g., uncontrolled diabetes) affecting dental health.
  • Participants taking medications that affect pulp sensation or vascular response (e.g., long-term anti-inflammatories).
  • Participants who are pregnant or breastfeeding.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Armed Forces Intitute of Denistry (AFID), Combined Military Hospital (CMH)

    Rawalpindi, Punjab Province, 44000

Other trials in Pakistan

About this study

Official title: Pulp Temperature Elevation During Interproximal Reduction: An In Vivo Quantification of Temperature Changes Across Different Slenderization Methods

The goal of this study is to learn about the temperature rise inside the living part of a tooth (the pulp) during different ways of removing a small amount of enamel (the hard outer layer of the tooth), a procedure called Interproximal Enamel Reduction (IPR).

The goal of this study is to learn about the temperature rise inside the living part of a tooth (the pulp) during different ways of removing a small amount of enamel (the hard outer layer of the tooth), a procedure called Interproximal Enamel Reduction (IPR).

Read more

The main question it aims to answer is:

Which IPR technique causes the highest temperature rise in the live tooth pulp?

This study is important because, until now, no research has measured these temperature changes in the live pulp of teeth inside a person's mouth (in vivo) that includes both premolars and front teeth (incisors). The original studies only used premolars, and the results might be different for front teeth due to the difference in enamel thickness.

Researchers will use 20 premolar teeth and 20 incisors that will be scheduled for extraction as part of orthodontic treatment. The teeth will be divided into two groups based on the IPR method used:

Group 1: IPR using a high-speed air-driven drill (airotor) and bur. Group 2: IPR using an orthodontic IPR kit (an oscillating system).

Participants will:

Receive local anesthesia to numb the tooth. Have the baseline temperature of the pulp recorded using temperature sensor on either side of the teeth.

Have the temperature changes in the pulp recorded using temperature sensor while IPR is performed on the sides of the tooth.

Have the tooth extracted afterward (as part of original orthodontic plan)

The key findings may provide information of the IPR method that cause a temperature rise high enough to harm the pulp. A rise beyond 5.5∘C may cause pulp damage.

Read the detailed description

Study Objectives The primary goal of this investigation is to evaluate the in vivo (inside the body) temperature rise within the dental pulp (the living tissue inside the tooth) when different techniques of Interproximal Enamel Reduction (IPR) are performed.

The core aims are:

  1. To measure and compare the magnitude of pulp temperature increase across two common IPR methods.
  2. To determine if any of the evaluated techniques have the potential to raise the pulp temperature above a critical threshold (5.5 degrees C), which is historically associated with irreversible pulp damage.
  3. To identify which IPR technique carries the highest possibility of thermal injury.

Rationale and Significance Previous studies that looked at this issue were performed ex vivo (on extracted, non-living teeth). This study is crucial because it measures temperature changes in live, intact teeth under actual clinical conditions, providing a more reliable assessment of risk.

A key difference in this research, compared to other literature, is the inclusion of both incisors (front teeth) and premolars. Since the enamel thickness on incisors is generally less than on premolars, there is a possibility that the heat generated during IPR may transfer more readily to the pulp in the anterior teeth, potentially leading to a greater temperature rise and a higher risk of adverse thermal effects. This study aims to clarify this potential risk.

Study Design and Methods This is a randomized clinical trial, an in vivo study involving participants undergoing orthodontic treatment where tooth extraction is required.

Participant Population The study will involve participants for whom the extraction of specific teeth (premolars and incisors) has been clinically advised as part of their orthodontic treatment plan. These teeth will be used for the IPR procedures just before they are extracted.

Procedure Groups (Interventions)

The teeth will be randomly assigned to one of the following two IPR technique groups, with the potential for each to generate a different amount of frictional heat:

  1. High-Speed Air-Driven Drill (Airotor and Bur): This method involves high rotational speed (potentially over 300,000 RPM) and thus has the highest possibility of causing the greatest temperature elevation due to intense friction.
  2. Orthodontic IPR Kit (Oscillating System): This technique operates at a much lower speed (around 5,000 RPM) and is expected to result in a moderate temperature increase, presenting a moderate possibility of thermal effect compared to the high-speed drill.

Measurement Prior to the IPR procedure, local anesthesia will be administered. A sensitive thermocouple directly on the surface of tooth to meausre baseline temperature of the pulp.

The chosen IPR procedure will be performed. The temperature changes in the pulp will be monitored at two time points and recorded during the IPR process.

The data gathered will be used to compare the techniques and determine the relative possibility of thermal damage posed by each method, particularly within the incisors, which are uniquely included in this research.

Being tested
High-Speed Air-Driven Drill (Airotor and Bur), Orthodontic IPR Kit (Oscillating System)
Keywords
IPR, interproximal reduction, slenderization, thermal pulp damage, irreversible pulpitis, premolars, incisors
Medical subject headings
Dental Pulp Necrosis, Bicuspid Aortic Valve Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-Speed Air-Driven Drill (Airotor and Bur)Device

    This method involves high rotational speed (potentially over 300,000 RPM) and thus has the highest possibility of causing the greatest temperature elevation due to intense friction during interproximal reduction.

  • Orthodontic IPR Kit (Oscillating System)Device

    This technique operates at a much lower speed (around 5,000 RPM) and is expected to result in a moderate temperature increase, presenting a moderate possibility of thermal effect compared to the high-speed drill during interproximal reduction.

Study groups in NCT07391124
Study groupRoleWhat they receive
Premolar GroupExperimentalBilateral premolars planned for extraction as part of orthodontic treatment in a patient will undergo intervention using both the IPR methods to measure the changes in pup temperature. First baseline temperature wil be recorded intraorally then one side premolar (e.g; right) will undergo IPR using Air-rotor system and then the other side premolar (e.g; left) will undergo IPR using oscillating strip
Receives: Device: High-Speed Air-Driven Drill (Airotor and Bur); Device: Orthodontic IPR Kit (Oscillating System)
Incisor GroupExperimentalPatients planned for lower single incisor extraction will be divided into two groups and undergo IPR using two different IPR techniques intraorally prior to extraction of the tooth.
Receives: Device: High-Speed Air-Driven Drill (Airotor and Bur); Device: Orthodontic IPR Kit (Oscillating System)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The highest temperature reached inside the pulp chamber for each tooth during the IPR procedure

    The highest temperature reached inside the pulp chamber for each tooth during the IPR procedure will be recorded using temperature sensor keeping it on the mid, mesial and distal facial surfaces of the tooth at different tie points; T0 (prior to IPR procedure), TD (during IPR procedure with the techniques specified) T1 (immediately after IPR), and T2 (after 5 mins post IPR)

    Measured: From enrollment to the date of planned extraction of the patient's teeth at 8 weeks so that all the measurements can be taken from T0 to T2 [T0 (prior to IPR procedure), TD (during IPR procedure with the techniques specified) T1 (immediately after IPR)]

  2. Mean maximum temperature rise per IPR technique

    Description: The calculated average of the maximum temperature rise for all teeth treated with a specific IPR technique.

    Analysis: This measure will be broken down by IPR technique and by tooth type (incisors vs. premolars).

    Conclusion: The method that consistently produces the lowest mean temperature rise across all groups is considered the most thermally conservative method.

    Measured: from enrollment to the point of extraction of patient's teeth at 8 weeks

Secondary outcomes (1)
  1. Residual Pulp Temperature Difference at 5 Minutes Post-IPR

    The remaining temperature difference between the recorded pulp temperature at the 5-minute mark (T2) and the tooth's original baseline temperature (T0).

    This directly measures the thermal recovery efficiency of the tooth. A difference closer to 0∘ C will indicate faster and more complete recovery, suggesting the IPR technique/tooth type is better able to manage thermal stress.

    Measured: From enrollment to the date of planned extraction of the patient's teeth at 8 weeks so that all the measurements can be taken from T0 to T2 [T0 (prior to IPR procedure), TD (during IPR procedure with the techniques specified) T1 (immediately after IPR)]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2026
  2. Study start29 Sep 2024
  3. Primary completion29 Oct 2026 (estimated)
  4. Study completion29 Oct 2026 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07391124
Sponsor's protocol ID
918/Trg
Acronym
IPR
Status last verified
Feb 2026
First submitted
30 Sep 2025
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Conditions for Sharing: Request Process: Requests must be made formally to the Principal Investigator (or corresponding author) of the study. Purpose: Requests must include a detailed research proposal outlining the scientific rationale for using the data. Anonymization: All shared data will be fully anonymized to protect participant confidentiality and meet the requirements set forth by the institutional ethics review board. Timing: Data will be made available following the publication of the main study results. Data Use Agreement: Researchers accessing the data will be required to sign a formal data use agreement to ensure the data is used only for the approved purpose and is not shared further.

Questions about this trial

What is this clinical trial studying?

A study testing High-Speed Air-Driven Drill (Airotor and Bur) and Orthodontic IPR Kit (Oscillating System) in people with Irreversible Pulpitis and Reversible Pulpitis, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.

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: under way, not looking for participants, as of the sponsor's last update on 17 Feb 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 Pakistan. 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?

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?

The highest temperature reached inside the pulp chamber for each tooth during the IPR procedure (time frame: From enrollment to the date of planned extraction of the patient's teeth at 8 weeks so that all the measurements can be taken from T0 to T2 [T0 (prior to IPR procedure), TD (during IPR procedure with the techniques specified) T1 (immediately after IPR)]). 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 17 Feb 2026.

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