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NCT Number: NCT02918903

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

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.

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Key information

Conditions

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of denntistry

Cairo, El-manyal, 11553, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Minimal caries removal

Procedure

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.

Complete caries removal

Procedure

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.

Primary outcomes

  1. Post operative pain assessed by direct questioning as binary outcome

    Time frame: 9 months

    Assessed by direct questioning pain history

Secondary outcomes

  1. incidence of pulp exposure

    Time frame: Within 30 minutes

    The outcome will be measured during the treatment visit which is estimated to be 30 minutes

  2. radio-graphic success

    Time frame: 9 months

    No external or internal root resorption, no periapical or furcation radiolucencies, no widening of periodontal membrane space

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 29, 2016
Registry last updated
Jun 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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