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

Not Applicable

Completed

• Conditions: Deep Caries
• Interventions: Procedure: Complete caries removal; Procedure: Minimal caries removal

• Registration Number: NCT02918903
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-29
• Study Start: 2018-12-15
• Primary Completion: 2020-03-15
• Study Completion: 2020-07-15
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-27
• Last Update Posted: 2021-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

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Exclusion Criteria

1. Patients experience any signs or symptoms of pulpal or peri-apical pathology.
2. Patients with systemic diseases requiring special dental consideration.
3. Unmotivated, uncooperative patients.
4. Patients unable to attend follow-up visits.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Complete caries removal	Complete caries removal	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.
Minimal caries removal	Minimal caries removal	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.

Primary Outcome Measures

Name	Time	Method
Post operative pain assessed by direct questioning as binary outcome	9 months	Assessed by direct questioning pain history

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of denntistry; 🇪🇬 Cairo, El-manyal, Egypt