In Vivo Pulp Thermal Changes During Different Slenderization Techniques

NCT07391124 | Active Not Recruiting

• 1 other identifier: 918/Trg
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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). 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.

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

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  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

  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)]

Study Arms (2)

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

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.

Device: High-Speed Air-Driven Drill (Airotor and Bur); Device: Orthodontic IPR Kit (Oscillating System)

Interventions

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.

Incisor Group; Premolar Group

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.

Incisor Group; Premolar Group

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Armed Forces Institute of Dentistry, Pakistan: lead

Study Sites (1)

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

Rawalpindi, Punjab Province, 44000, Pakistan

Location

Related Links

• 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.

MeSH Terms

Conditions

Dental Pulp Necrosis; Bicuspid Aortic Valve Disease

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Aortic Valve Disease; Heart Valve Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Alaina Tariq Mughal, BDS, FCPS (R)

  Armed Forces Institute of Dentistry, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: February 5, 2026
• Study Start: September 29, 2024
• Primary Completion (Estimated): October 29, 2026
• Study Completion (Estimated): October 29, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

PA (1)