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

NCT05529433 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2022-09-07

No results posted yet for this study

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.

Conditions

  • Dental Caries in Children

Interventions

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.

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.

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Rania Nasr, Professor · Cairo University

  • Rasha Hatem, Associate Professor · Cairo University

  • Reham Mahmoud, BDS · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2022-11-30
Completion
2023-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05529433 on ClinicalTrials.gov