Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars
Primary Purpose
Dental Caries in Children
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Atraumatic Restorative Treatment (ART)
Smart Burs
Chemo-Mechanical Caries Removal (CMCR)
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries in Children
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Atraumatic Restorative Treatment (ART)
Smart Burs
Chemo-Mechanical Caries Removal (CMCR)
Arm Description
Atraumatic Restorative Treatment is a simple technique based on preservation of sound tooth structure and minimal patient's discomfort.
Smart Burs are minimally invasive technique which selectively removes the infected carious dentin leaving the affected intact dentin.
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.
Outcomes
Primary Outcome Measures
Pain assessment
The pain will be assessed by Visual Analogue Scale (VAS)
Secondary Outcome Measures
Time taken for caries removal
The time is measured by a stopwatch in minutes
Efficacy of caries removal
The efficacy of caries removal will be assessed by Caries Detector dye.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05529433
Brief Title
Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars
Official Title
Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Atraumatic Restorative Treatment (ART)
Arm Type
Active Comparator
Arm Description
Atraumatic Restorative Treatment is a simple technique based on preservation of sound tooth structure and minimal patient's discomfort.
Arm Title
Smart Burs
Arm Type
Experimental
Arm Description
Smart Burs are minimally invasive technique which selectively removes the infected carious dentin leaving the affected intact dentin.
Arm Title
Chemo-Mechanical Caries Removal (CMCR)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Atraumatic Restorative Treatment (ART)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Smart Burs
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Chemo-Mechanical Caries Removal (CMCR)
Other Intervention Name(s)
Selecti-Solve gel (Denta Pharma, Egypt)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain assessment
Description
The pain will be assessed by Visual Analogue Scale (VAS)
Time Frame
at baseline
Secondary Outcome Measure Information:
Title
Time taken for caries removal
Description
The time is measured by a stopwatch in minutes
Time Frame
at baseline
Title
Efficacy of caries removal
Description
The efficacy of caries removal will be assessed by Caries Detector dye.
Time Frame
at baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reham Mahmoud, BDS
Phone
+201117892999
Email
reham_mahmoud@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Rania Nasr, Professor
Phone
+201005037367
Email
rania.nasr@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rania Nasr, Professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rasha Hatem, Associate Professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Reham Mahmoud, BDS
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars
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