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

NCT ID: NCT02918903

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-15
• Study Completion Date: 2020-07-15

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.

Conditions

Deep Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Minimal caries removal

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Complete caries removal

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nouran Mamdouh Ahmed

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of denntistry

Cairo, El-manyal, Egypt

Countries

Egypt

Other Identifiers

CEBD-CU-2016-09-206

Identifier Type: -

Identifier Source: org_study_id