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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Dental Caries in Children

Treatments: Procedure: Smart Burs; Procedure: Atraumatic Restorative Treatment (ART); Procedure: Chemo-Mechanical Caries Removal (CMCR)

Study type: Interventional

Funder types: Other

Identifiers

NCT05529433

b9xe7bsh

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 estimated patients

Sex: All

Ages: 4 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

33 participants in 3 patient groups

Atraumatic Restorative Treatment (ART)

Active Comparator group

Description:

Atraumatic Restorative Treatment is a simple technique based on preservation of sound tooth structure and minimal patient's discomfort.

Treatment:

Procedure: Atraumatic Restorative Treatment (ART)

Smart Burs

Experimental group

Description:

Smart Burs are minimally invasive technique which selectively removes the infected carious dentin leaving the affected intact dentin.

Treatment:

Procedure: Smart Burs

Chemo-Mechanical Caries Removal (CMCR)

Experimental group

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.

Treatment:

Procedure: Chemo-Mechanical Caries Removal (CMCR)