Evaluation of Pulp Symptoms After Minimal Caries Removal in Treatment of Deep Caries

Study Overview
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Brief Summary
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The objective of this study is to assess and compare the possible post-operative pulpal symptoms (Spontaneous pain, pain on percussion, swelling, sinus or fistula), incidence of pulp exposure, child acceptance, chair time and radiographic success between two techniques for managing dental caries: minimal caries removal and complete caries removal in primary molars.

Detailed Description
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Minimal Caries Removal (MCR) technique was described in 2015 by Chompu-inwai et al., as a treatment option for primary molars with deep carious lesions or reversible pulpitis where only soft demineralized dentin around the lateral walls of the carious lesion is removed. The aim of this study is to assess the success of such a technique in managing primary molars with asymptomatic deep caries in terms of; post-operative pulpal symptoms(spontaneous pain, pain on percussion, fistula or sinus), incidence of pulp exposure, child acceptance, chair time and radiographic success.

Official Title
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Evaluation of Pulpal Symptoms Following Minimal Caries Removal Technique in Comparison to Complete Caries Removal in Molars With Deep Caries

Conditions
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Deep Caries

Intervention / Treatment
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* Procedure: Minimal caries removal
* Procedure: Complete caries removal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary molar with deep dentin caries involving occlusal &/or occluso-proximal surfaces. Absence of clinical signs and symptoms of irreversible pulpitis such as spontaneous pain. Only presence of pain provoked with stimulation, such as complaints of food impaction when eating is allowed. Absence of clinical swelling or pus exudates/fistula of soft or periodontal tissues. Absence of abnormal tooth mobility. Absence of pain on percussion. Restorable tooth. Radiographic inclusion criteria: Extension of dental caries one-third or more of the entire dentin thickness. No super- imposition of dental caries on the dental pulp. No widened periodontal ligament (PDL) space. No radiolucency in the peri-apical or furcation areas. No pathologic internal or external root resorption. No pulp canal calcification or obliteration. Exclusion Criteria: Patients experience any signs or symptoms of pulpal or peri-apical pathology. Patients with systemic diseases requiring special dental consideration. Unmotivated, uncooperative patients. Patients unable to attend follow-up visits.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minimal caries removal<br>the patients in this group will be treated by minimal caries removal technique, where only caries at lateral walls of cavity is removed, stainless steel crown preparation is performed and then stainless steel crown is placed as final restoration. | Procedure: Minimal caries removal<br>* the experimental group will be treated by minimal caries removal where only caries at lateral walls of cavity will be removed then stainless steel crown will be placed as final restoration.<br>|
| Active Comparator: Complete caries removal<br>patients in this group will be treated by complete caries removal technique, where all caries will be removed, a base of resin modified glass ionomer is placed and then stainless steel crown is placed as final restoration. | Procedure: Complete caries removal<br>* the control group will be treated by complete caries removal where all caries along lateral and pulpal walls of cavity will be removed, a base of resin modified glass ionomer will be placed then stainless steel crown will be placed as final restoration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain assessed by direct questioning as binary outcome | Assessed by direct questioning pain history | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of pulp exposure | The outcome will be measured during the treatment visit which is estimated to be 30 minutes | Within 30 minutes | 
| radio-graphic success | No external or internal root resorption, no periapical or furcation radiolucencies, no widening of periodontal membrane space | 9 months |