An interventional study of High-Speed Air-Driven Drill (Airotor and Bur) and Orthodontic IPR Kit (Oscillating System) in Irreversible Pulpitis, Reversible Pulpitis and Thermal Injury, sponsored by Armed Forces Institute of Dentistry, Pakistan. Active, not recruiting at 1 site in Pakistan. Open to participants aged 12 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Armed Forces Institute of Dentistry, Pakistan · Not applicable, Interventional, and Prevention
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).
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.
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:
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:
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.
149 studies on the registry are indexed under Dental Pulp Necrosis; 39 are open to participants now.
This study's planned enrollment of 30 is below the median of 44 across 139 interventional studies indexed under Dental Pulp Necrosis.
Browse Dental Pulp Necrosis studies →Armed Forces Institute of Dentistry, Pakistan is the lead sponsor of 27 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bilateral 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
Device: High-Speed Air-Driven Drill (Airotor and Bur) · Device: Orthodontic IPR Kit (Oscillating System)
Patients 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.
Device: High-Speed Air-Driven Drill (Airotor and Bur) · Device: Orthodontic IPR Kit (Oscillating System)
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.
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.
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)
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)]
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.
Time frame: from enrollment to the point of extraction of patient's teeth at 8 weeks
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.
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)]
Plan to share: 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.
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Armed Forces Institute of Dentistry, Pakistan