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

NCT ID: NCT05529433

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2023-02-28

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.

Conditions

Dental Caries in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Atraumatic Restorative Treatment (ART)

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

Group Type: ACTIVE_COMPARATOR

Atraumatic Restorative Treatment (ART)

Intervention Type: PROCEDURE

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

Group Type: EXPERIMENTAL

Smart Burs

Intervention Type: PROCEDURE

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)

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.

Group Type: EXPERIMENTAL

Chemo-Mechanical Caries Removal (CMCR)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Selecti-Solve gel (Denta Pharma, Egypt)

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Reham Mahmoud Abdel Sattar El sayed

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rania Nasr, Professor

Role: STUDY_DIRECTOR

Cairo University

Rasha Hatem, Associate Professor

Role: STUDY_DIRECTOR

Cairo University

Reham Mahmoud, BDS

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Central Contacts

Reham Mahmoud, BDS

Role: CONTACT

reham_mahmoud@dentistry.cu.edu.eg

+201117892999

Rania Nasr, Professor

Role: CONTACT

rania.nasr@dentistry.cu.edu.eg

+201005037367

Other Identifiers

b9xe7bsh

Identifier Type: -

Identifier Source: org_study_id