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

Deep Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02918903
• Other study ID #: CEBD-CU-2016-09-206
• Status: Completed
• Phase: N/A
• Start date: December 15, 2018
• Est. completion date: July 15, 2020

Study information

• Verified date: June 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deep Caries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of denntistry	Cairo	El-manyal

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative pain assessed by direct questioning as binary outcome	Assessed by direct questioning pain history	9 months
Secondary	incidence of pulp exposure	The outcome will be measured during the treatment visit which is estimated to be 30 minutes	Within 30 minutes
Secondary	radio-graphic success	No external or internal root resorption, no periapical or furcation radiolucencies, no widening of periodontal membrane space	9 months