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

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.

Study Overview

• Status: Completed
• Conditions: Deep Caries
• Intervention / Treatment: Procedure: Minimal caries removal; Procedure: Complete caries removal

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-manyal
    • Cairo, El-manyal, Egypt, 11553
      • Faculty of denntistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Minimal 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.
Active Comparator: 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.	Procedure: Complete 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2018
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): July 15, 2020

Study Registration Dates

• First Submitted: September 26, 2016
• First Submitted That Met QC Criteria: September 27, 2016
• First Posted (Estimate): September 29, 2016

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 27, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CEBD-CU-2016-09-206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No