Clinical effectiveness of Chemomechanical versus Conventional caries removal for alternative restorative treatment.

Aims : To assess the clinical effectiveness of Chemomechanical

versus Conventional caries removal for alternative restorative

treatment (ART).

Objectives:

To compare the success of the restorations at 1, 6 and 12

months between the groups.

To compare the time taken and pain reaction measured by

the Sound, Eye, and Motor scale (SEM) between the

groups.

Justification for study (whether of national significance with

rationale) :

Chemomechanical caries removal technique provides less anxiety

and more clinical acceptance thus instilling a positive attitude

towards dental treatment in a person. This study would also

provide information regarding the efficacy of newer caries

removal techniques that can be used in community or field

settings.

Departments involved: Department of Public Health Dentistry,

Manipal college of Dental Sciences, Manipal.

Study period: 18 months

Sample size: G-power software, 82 (With the effect size of 0.5,

power of 95% and significance level of α=0.05, yielded a sample

size of 52. Considering an attrition of 20%, we inflated the sample

size to 82.)

Materials and methods:

a) Inclusion criteria:

Children aged 6-15 years, with one or more than one cavitated

carious lesions, single surface, occlusal load bearing area,

which are be accessible to hand instruments in permanent

dentition.

Consent given by children and their parents are included.

b) Exclusion criteria :

Presence or history of pain/abscess/fistula/swelling near to the

carious tooth.

Deep carious lesions exposing pulp of tooth.

Presence of tenderness on percussion.

Children with syndromes, undergoing orthodontic treatment,

developmental defects of teeth, or any other conditions that

contraindicate the caries excavation/restorations.

c) Biological materials required (type - blood, tissue etc and

quantity): Nil

d) Statistical methods: Intergroup comparisons would be done

with chi-square test/ Student t-test

9. Detailed description of procedure / processes:

School children would be screened based on inclusion and

exclusion criteria. Eligible children and their parents would be

approached for consent and participation in the study. Children

would be randomized into Group I and Group II based on the block

randomization.

Group 1 will receive Chemomechanical caries removal using

Carie care as per manufacturer instructions followed by

alternative restorative treatment using Fuji IX restorative

material.

Group 2 will receive conventional caries removal using

excavators followed by alternative restorative treatment using Fuji IX restorative material.

evaluated at 1, 6 and 12 months (scores 0, 1 and 7)

11. Potential risks: Children may experience mild discomfort

during excavation of caries.

Benefits: Treatment of caries at early stages prevents further

progression of the disease.

12. Ethical considerations and methods to address issues :

Informed consent, indirect identifiers for maintaining

confidentiality. Patient may experience pain which might

require root canal treatment. Camp cards will be provided to

avail the necessary treatment at subsidized rates.

13. Budget : 12,100