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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02918903
Enrollment
70
Registered
2016-09-29
Start date
2018-12-15
Completion date
2020-07-15
Last updated
2021-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Caries

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.

Interventions

PROCEDUREMinimal caries removal

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.

PROCEDUREComplete caries removal

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Post operative pain assessed by direct questioning as binary outcome9 monthsAssessed by direct questioning pain history

Secondary

MeasureTime frameDescription
incidence of pulp exposureWithin 30 minutesThe outcome will be measured during the treatment visit which is estimated to be 30 minutes
radio-graphic success9 monthsNo external or internal root resorption, no periapical or furcation radiolucencies, no widening of periodontal membrane space

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026