Anxiety During Caries Removal Using Chemo-mechanical Versus Conventional Methods

Cairo University (CU)

Status: Not yet enrolling

Conditions: Caries Active

Treatments: Procedure: Cariemove; Procedure: Drilling using bur

Study type: Interventional

Funder types: Other

Identifiers

NCT07344415

Cariemove

Details and patient eligibility

About

This study aims to clinically assess this newly introduced Egyptian chemo-mechanical caries removal gel versus conventional drilling method . The concept of preserving healthy tooth structures and employing atraumatic restorative techniques during cavity preparation aligns with the principles of minimally invasive dentistry. This approach prioritizes patient comfort, reassurance, and fosters a positive perception of dental treatment.

Full description

Dental caries is a multifactorial dynamic disease that involves mineral loss of dental hard tissue. Caries management is the action made to interfere with the loss of minerals that could be non-operative or operative interventions according to the stage and severity of the case. In deep carious lesions, removal of caries using rotary instruments has been the most prevalent technique. This could be attributed to being rapid and efficient in caries removal. However, such technique possesses some drawbacks in terms of patient discomfort, thermal stimulation to the pulp and unnecessary excessive removal of tissues. Minimally invasive dentistry is the philosophy that aims for lesion control as well as minimal operative intervention. Preserving dental tissue by early caries detection of as well as combining non-operative minimally invasive restorative procedures are its main objective. Therefore, alternative techniques have been proposed to overcome the drawbacks of rotary instrumentation of deep lesions. One of the techniques is chemico-mechanical caries removal. Chemico-mechanical caries removal is based on enzymatic action on carious tissues dissolving them to be easily removed using an excavator. Such system allows better patient perception by avoiding the vibration caused by rotary instruments. It also helps in avoiding excessive pulpal irritation caused by the heat generated while using rotary instruments. Cariemove ,a newly introduced Egyptian product, that is based on amino acids, sodium hypochlorite and carboxyglyciene has been introduced in the market. This system lacks sufficient literature about its clinical efficiency and level of anxiety of patients during caries removal.

Enrollment: 80 estimated patients

Sex: All

Ages: 10 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Open carious lesions with dentin involvement, but not involving the pulp in lower molars.
2. The access of the carious lesion has to be large enough to allow the penetration of the excavator.
3. Asymptomatic vital teeth, without clinical evidence of pulp, furcation, or periapical pathology.
4. Patients who sign informed consent.
5. Co-operative patients approving to participate in the trial.

Exclusion criteria

1. Patients with spontaneous or elicited pain from caries.
2. Patients with systemic diseases.
3. Presence of intraoral/extraoral swellings.
4. Deep dental caries involving pulp.
5. Presence of swelling/fistula in relation to carious tooth.
6. Inability to return for recall visits.
7. Patients with bad oral hygiene
8. Refuse to participate in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Chemo-mechanical

Experimental group

Treatment:

Procedure: Cariemove

Conventional rotary

Active Comparator group

Treatment:

Procedure: Drilling using bur