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

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02918903
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 19
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Deep Caries	Procedure: Minimal caries removal; Procedure: Complete caries removal	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of Pulpal Symptoms Following Minimal Caries Removal Technique in Comparison to Complete Caries Removal in Molars With Deep Caries
• Actual Study Start Date: Dec 15, 2018
• Actual Primary Completion Date: Mar 15, 2020
• Actual Study Completion Date: Jul 15, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Post operative pain assessed by direct questioning as binary outcome [9 months]

   Assessed by direct questioning pain history

Secondary Outcome Measures

1. incidence of pulp exposure [Within 30 minutes]

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

2. radio-graphic success [9 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 8 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of denntistry	Cairo	El-manyal	Egypt	11553

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nouran Mamdouh Ahmed, Assistant lecturer, Cairo University
• ClinicalTrials.gov Identifier: NCT02918903
• Other Study ID Numbers: CEBD-CU-2016-09-206
• First Posted: Sep 29, 2016
• Last Update Posted: Jun 30, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 30, 2021