Anxiety During Caries Removal Using Chemo-mechanical Versus Conventional Methods
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cariemove, Drilling using bur.
- Who it may be relevant to
- Registry conditions: Caries Active. Basic parameters: 10 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Level of Anxiety During Caries Removal Using a New Chemo-mechanical Caries Removal System Versus Conventional Drilling Method: A Randomized Controlled Trial
Overview
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.
Detailed 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.
Interventions
- Procedure Cariemove
It is a newly introduced Egyptian product. It consists of a transparent liquid containing 0.5% sodium hypochlorite, 0.1 M mixtures of three amino acids, leucine, lysine and glutamic acid. - Procedure Drilling using bur
Rotary dental burs using high speed hand piece under water spray cooling system
Primary outcome measures
- Level of anxiety and discomfort [Time frame: Baseline (Day 1)]
Eligibility criteria
Inclusion criteria
- Open carious lesions with dentin involvement, but not involving the pulp in lower molars.
- The access of the carious lesion has to be large enough to allow the penetration of the excavator.
- Asymptomatic vital teeth, without clinical evidence of pulp, furcation, or periapical pathology.
- Patients who sign informed consent.
- Co-operative patients approving to participate in the trial.
Exclusion criteria
- Patients with spontaneous or elicited pain from caries.
- Patients with systemic diseases.
- Presence of intraoral/extraoral swellings.
- Deep dental caries involving pulp.
- Presence of swelling/fistula in relation to carious tooth.
- Inability to return for recall visits.
- Patients with bad oral hygiene
- Refuse to participate in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dentistry Cairo University — Cairo
Identifiers
NCT: NCT07344415 · Cariemove