Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars
1 other identifier
interventional
33
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
September 2, 2022
CompletedFirst Posted
Study publicly available on registry
September 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedSeptember 7, 2022
September 1, 2022
2 months
September 2, 2022
September 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Pain assessment
The pain will be assessed by Visual Analogue Scale (VAS)
at baseline
Secondary Outcomes (2)
Time taken for caries removal
at baseline
Efficacy of caries removal
at baseline
Study Arms (3)
Atraumatic Restorative Treatment (ART)
ACTIVE COMPARATORAtraumatic Restorative Treatment is a simple technique based on preservation of sound tooth structure and minimal patient's discomfort.
Smart Burs
EXPERIMENTALSmart Burs are minimally invasive technique which selectively removes the infected carious dentin leaving the affected intact dentin.
Chemo-Mechanical Caries Removal (CMCR)
EXPERIMENTALA chemical agent which selectively removes the carious dentin by breaking the denatured collagen fibers making them soft and preserving the healthy dentin without drilling.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Caries in second primary molars within enamel/ dentin without pulp disease.
- There is a clear band of dentin coronal.
- Cooperative and healthy children.
You may not qualify if:
- Presence of signs and symptoms of necrosis.
- Root caries.
- History of spontaneous pain.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rania Nasr, Professor
Cairo University
- STUDY DIRECTOR
Rasha Hatem, Associate Professor
Cairo University
- PRINCIPAL INVESTIGATOR
Reham Mahmoud, BDS
Cairo University
Central Study Contacts
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
- principle investigator
Study Record Dates
First Submitted
September 2, 2022
First Posted
September 7, 2022
Study Start
September 1, 2022
Primary Completion
November 1, 2022
Study Completion
February 1, 2023
Last Updated
September 7, 2022
Record last verified: 2022-09