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

NCT02918903 | Completed DMC

• 1 other identifier: CEBD-CU-2016-09-206
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Caries

Outcome Measures

Primary Outcomes (1)

• Post operative pain assessed by direct questioning as binary outcome

  Assessed by direct questioning pain history

  9 months

Secondary Outcomes (2)

• incidence of pulp exposure

  Within 30 minutes

• radio-graphic success

  9 months

Study Arms (2)

Minimal caries removal

EXPERIMENTAL

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

Complete caries removal

ACTIVE COMPARATOR

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

Interventions

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.

Minimal caries removal

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.

Complete caries removal

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of denntistry

Cairo, El-manyal, 11553, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 29, 2016
• Study Start: December 15, 2018
• Primary Completion: March 15, 2020
• Study Completion: July 15, 2020
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)