An interventional study of polymer burs and Carisolv in Pain During Caries Excavation, sponsored by Rehman Medical Institute - RMI. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Rehman Medical Institute - RMI · Not applicable, Interventional, and Supportive care
The goal of this randomized controlled trial is to compare the amount of pain experienced during removal of dental caries using Smart burs, Carisolv, and conventional diamond burs in adults aged 18-45 years with active caries in asymptomatic mandibular molars.
The main questions it aims to answer are:
Does the method used for caries removal affect the amount of pain experienced?
Is there a difference in pain perception between Smart burs, Carisolv, and conventional diamond burs?
Researchers will compare the three treatment groups to see whether pain perception during caries excavation differs between the methods.
Participants will:
Be randomly assigned to one of three groups: Smart burs, Carisolv, or conventional diamond burs.
Undergo caries removal using the assigned method.
Rate their pain during the procedure using a 0-10 Visual Analogue Scale (VAS).
Dental caries is a biofilm-mediated disease in which the progression of the carious lesion results in the demineralization and structural breakdown of dental hard tissues. Contemporary operative dentistry emphasizes minimally invasive management, with the selective removal of irreversibly damaged, infected dentin while preserving tissue that may remain structurally and biologically capable of repair. The choice of caries excavation technique may influence the amount of sound tooth structure removed, the mechanical stimulation of dentin, treatment time, and patient comfort.
Conventional rotary excavation is commonly performed using diamond or carbide burs. Although effective, rotary instrumentation may involve unnecessary removal of sound or potentially remineralizable dentin and can produce mechanical and thermal stimuli that may contribute to discomfort during treatment. Alternative excavation methods have therefore been developed to achieve more selective removal of carious tissue.
Smart polymer burs are designed to selectively remove softer, infected dentin while minimizing cutting of harder, sound dentin. The burs are manufactured from a polymer material with a hardness intermediate between infected and sound dentin. They are used at low rotational speed and are intended to reduce unnecessary removal of tooth structure. When the bur encounters harder dentin, its cutting efficiency is reduced, thereby supporting a more conservative excavation approach.
Carisolv is a chemomechanical caries-removal system. Its gel formulation contains sodium hypochlorite together with amino acids and is intended to soften altered carious dentin. Following chemical softening, the softened tissue is removed with appropriate hand instrumentation. The technique is based on selective removal of carious tissue rather than conventional high-speed mechanical cutting.
The present study is designed as a three-arm, parallel-group randomized clinical trial. After assessment and enrollment, participants will be allocated to one of three intervention groups using a simple randomization procedure. The intervention will be performed on the eligible carious tooth according to the assigned excavation technique. The same clinical operator or appropriately trained operator will follow a standardized protocol for the respective technique to minimize variation in treatment delivery.
For the Smart-bur group, carious dentin will be excavated using the designated polymer bur with a slow-speed handpiece according to the manufacturer's recommended operating conditions. For the Carisolv group, the Carisolv gel will be applied to the carious dentin according to the manufacturer's instructions, allowed to act on the affected tissue, and the softened carious material will subsequently be removed using suitable hand instruments. For the conventional group, caries will be excavated using conventional diamond burs with rotary instrumentation according to routine operative dentistry principles.
Radiographic and clinical assessment will be used before treatment to confirm the suitability of the selected tooth and to reduce the likelihood of including teeth with pulpal involvement. Treatment will be carried out under standardized clinical conditions. Participants will be monitored throughout the procedure, and the assigned excavation technique will be discontinued or modified if clinically indicated for patient safety or appropriate dental treatment.
Baseline demographic and relevant clinical information will be documented on a standardized data-collection form. Treatment allocation and study-related observations will be recorded by the research team under appropriate supervision. Data will subsequently be entered into a statistical database for analysis.
The principal analytical comparison will assess whether the three excavation techniques differ in the level of pain reported during the caries-removal procedure. Continuous variables will initially be summarized using appropriate descriptive statistics. Distributional assumptions will be assessed before selection of the final comparative statistical test. For normally distributed data, one-way analysis of variance will be used to compare the three independent groups. If the assumptions for parametric analysis are not satisfied, an appropriate non-parametric alternative will be considered. Statistical significance will be assessed at an alpha level of 0.05.
The study is intended to provide clinical evidence regarding the effect of different caries excavation approaches on patient comfort and to contribute to the evidence base for minimally invasive operative dentistry. The findings may help clinicians understand whether selective polymer-bur or chemomechanical excavation techniques provide a clinically meaningful difference in patient-reported discomfort compared with conventional rotary excavation.
1,137 studies on the registry are indexed under Dental Caries; 201 are open to participants now.
This study's planned enrollment of 66 is close to the median of 60 across 936 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Rehman Medical Institute - RMI is the lead sponsor of 21 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Device: polymer burs
Device: Carisolv
Device: Conventional Diamond Burs
Carious dentin will be selectively excavated using Smart polymer burs operated at low speed (500-800 rpm), aiming to preserve sound dentin.
Carious dentin will be chemically softened using Carisolv gel and subsequently removed with hand instruments.
Carious dentin will be removed using conventional rotary diamond burs under standard clinical operative dentistry procedures.
Intraoperative Pain Perception During Caries Excavation assessed using Visual Analogue Scale (VAS)
Intraoperative pain perception will be determined on visual analogue scale (VAS) to measure the pain intensity experienced by the patients during caries excavation. VAS involves scores from 0 to 10 where 0 indicates no pain and 10 represents worst pain possible. The VAS score will be recorded immediately after completion of caries excavation.
Time frame: immediately after completion of caries excavation
Plan to share: No — IPD will not be shared to protect participant privacy and confidentiality and in accordance with institutional ethical requirements. Only de-identified aggregate data will be reported.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Rehman Medical Institute - RMI