Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars

Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars: A Randomized Clinical Trial

The aim of the clinical trial is to assess pain during Atraumatic Restorative Treatment (ART), Smart Burs and Chemo-mechanical Caries Removal (CMCR) in primary molars.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Caries in Children
• Intervention / Treatment: Procedure: Atraumatic Restorative Treatment (ART); Procedure: Smart Burs; Procedure: Chemo-Mechanical Caries Removal (CMCR)

Detailed Description

The principles of the caries removal have changed greatly in the last decade. The use of local anesthesia with conventional techniques"high-speed hand piece" increase the fear and anxiety of the child. Minimally invasive techniques reduce the pain and anxiety of the child by eliminating the use of local anesthesia.

In ART, soft carious tissue is removed by hand instruments. Although this technique is very simple.

Moreover, Smart Burs are more efficient in removal of soft infected dentine than ART leaving the affected dentin intact; as when they touch hard dentin, they become dull.

Finally, the recent effective method of caries removal is CMCR. The chemical agent contains proteolytic enzyme which destructs partially degraded collagen, leaving the infected dentin soft and easy to be excavated.

Therefore, the aim of this study is to assess pain during Atraumatic Restorative treatment, Smart Burs and Chemo-Mechanical Caries Removal in primary molars.

• Study Type: Interventional
• Enrollment (Anticipated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reham Mahmoud, BDS; Phone Number: +201117892999; Email: reham_mahmoud@dentistry.cu.edu.eg
• Study Contact Backup: Name: Rania Nasr, Professor; Phone Number: +201005037367; Email: rania.nasr@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Caries in second primary molars within enamel/ dentin without pulp disease.
• There is a clear band of dentin coronal.
• Cooperative and healthy children.

Exclusion Criteria:

• Presence of signs and symptoms of necrosis.
• Root caries.
• History of spontaneous pain.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Atraumatic Restorative Treatment (ART); Atraumatic Restorative Treatment is a simple technique based on preservation of sound tooth structure and minimal patient's discomfort.	Procedure: Atraumatic Restorative Treatment (ART); Atraumatic Restorative Treatment is highly accepted by the patients as there is no need for local anesthesia. It is a minimal invasive technique which preserves sound tooth structure as caries removal will be done by a sharp spoon excavator. It requires less time during caries removal. There is a chemical bond between the tooth and the glass ionomer adhesive material. So, there is no need for cutting sound tooth structure for retention of the restoration.
Experimental: Smart Burs; Smart Burs are minimally invasive technique which selectively removes the infected carious dentin leaving the affected intact dentin.	Procedure: Smart Burs; Smart Bur is a polymer bur which removes only soft infected dentin as the cutting edges become dull in contact with the hard affected dentin.Caries removal will be done by Smart Bur mounted on a low speed hand-piece leaving the affected dentin intact. It requires less time for caries removal.
Experimental: Chemo-Mechanical Caries Removal (CMCR); A chemical agent which selectively removes the carious dentin by breaking the denatured collagen fibers making them soft and preserving the healthy dentin without drilling.	Procedure: Chemo-Mechanical Caries Removal (CMCR); Selecti-Solve gel is a dental gel which main active ingredient is Papain enzyme which selectively removes the caries without pain and has bacteriostatic, bactericidal and anti-inflammatory properties. The use of CMCR is recommended as an alternative treatment technique in anxious patients. The gel will be applied with a blunt spoon instrument and distributed well into the cavity according to manufacturer's instructions.; Other Names: Selecti-Solve gel (Denta Pharma, Egypt)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment	The pain will be assessed by Visual Analogue Scale (VAS)	at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time taken for caries removal	The time is measured by a stopwatch in minutes	at baseline
Efficacy of caries removal	The efficacy of caries removal will be assessed by Caries Detector dye.	at baseline

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Rania Nasr, Professor, Cairo University; Study Director: Rasha Hatem, Associate Professor, Cairo University; Principal Investigator: Reham Mahmoud, BDS, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: b9xe7bsh

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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