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.
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
- Conditions the study is for
- Irreversible Pulpitis, Reversible Pulpitis, Thermal Injury
- 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
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:
- To measure and compare the magnitude of pulp temperature increase across two common IPR methods.
- 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.
- 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:
- 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.
- 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.
- Conditions
- Irreversible Pulpitis, Reversible Pulpitis, Thermal Injury, Pulp Hyperemia, Pulp Necrosis, Pulp Inflammation
- 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 group | Role | What they receive |
|---|---|---|
| Premolar Group | Experimental | 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 Receives: Device: High-Speed Air-Driven Drill (Airotor and Bur); Device: Orthodontic IPR Kit (Oscillating System) |
| Incisor Group | Experimental | 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. 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.
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)]
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)
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.
- First posted5 Feb 2026
- Study start29 Sep 2024
- Primary completion29 Oct 2026 (estimated)
- Study completion29 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Dentistry, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaina Tariq Mughal, Armed Forces Institute of Dentistry, Pakistan
- Investigators
- Alaina Tariq Mughal, BDS, FCPS (R), Principal investigator, Armed Forces Institute of Dentistry, Pakistan
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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulp Temperature Elevation During Interproximal Reduction: An In Vivo Quantification of Temperature Changes Across Different Slenderization Methods
- ClinicalTrials.gov ID
- NCT07391124
- Acronym / sponsor ID
- IPR / 918/Trg
- Conditions
- Irreversible Pulpitis, Reversible Pulpitis, Thermal Injury, Pulp Hyperemia, Pulp Necrosis, Pulp Inflammation
- Keywords
- IPR, interproximal reduction, slenderization, thermal pulp damage, irreversible pulpitis, premolars, incisors
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- 29 Sep 2024 (actual)
- Primary completion
- 29 Oct 2026 (estimated)
- Study completion
- 29 Oct 2026 (estimated)
- First posted
- 5 Feb 2026 (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.
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.
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:
- To measure and compare the magnitude of pulp temperature increase across two common IPR methods.
- 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.
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premolar Group | Experimental | Device: High-Speed Air-Driven Drill (Airotor and Bur), Device: Orthodontic IPR Kit (Oscillating System)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 |
| Incisor Group | Experimental | 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. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| 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 during interproximal reduction. | Device | Incisor Group, Premolar Group |
| 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 during interproximal reduction. | Device | Incisor Group, Premolar Group |
Primary outcome
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 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)
Mean maximum temperature rise per IPR technique
Time frame: from enrollment to the point of extraction of patient's teeth at 8 weeks
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.
1 secondary outcome
Residual Pulp Temperature Difference at 5 Minutes 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)]
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 17 Feb 2026.
- In vivo study measuring pulp ΔT during IPR with high-speed, oscillating, and manual methods on premolars. All methods were deemed thermally safe (ΔT\<5.5 ∘C). This justifies extending the safety analysis to incisors.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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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. This study is not recruiting at the moment.
Alaina Tariq Mughal, BDS, FCPS (R) principal investigator
Armed Forces Institute of Dentistry, Pakistan
1 site in 1 country: see every site and its status.
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.