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

Dental Caries in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05529433
• Other study ID #: b9xe7bsh
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: February 2023

Study information

• Verified date: September 2022
• Source: Cairo University
• Contact: Reham Mahmoud, BDS
• Phone: +201117892999
• Email: reham_mahmoud[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 33
• Est. completion date: February 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment	The pain will be assessed by Visual Analogue Scale (VAS)	at baseline
Secondary	Time taken for caries removal	The time is measured by a stopwatch in minutes	at baseline
Secondary	Efficacy of caries removal	The efficacy of caries removal will be assessed by Caries Detector dye.	at baseline