Ozone Application in Stepwise Excavation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 105
- Primary Endpoint
- Changes microbiological count: from baseline to 4 months
Study Overview
Brief Summary
Purpose: The purpose of this study was to investigate the clinical and microbiological effectiveness of the ozone application in stepwise excavation of primary molars.
Methods: This study was conducted in vivo conditions with 105 lower primary second molars that had deep caries lesions with the risk of pulpal exposure. The teeth were randomly divided into three groups: Conventional stepwise excavation without any disinfectant, 2% chlorhexidine digluconate(CHX) and ozone application. In four different stages (after; initial excavation, ozone/CHX application, four months, final excavation), dentine samples were collected for microbiological analysis of mutans streptococci, lactobacilli and total number of colony forming units. Clinical changes as dentine colour, humidity, consistency were recorded. The data were analysed by Mann-Whitney U, Friedman and chi-square test.
Detailed Description
Informed consent including possible risks, discomforts and benefits about the procedure were obtained from all parents of the young patients.
The required sample size for this study was 35 in each subgroup (82 percent power, two-sided five percent significance level) for the detection of a significant difference. This study was conducted on 105 patients aged 6 to 10 years (59 girls, 46 boys) who attended the Pediatric Dentistry Department. None of the patients included in the study were medically compromised. Each patient had one mandibular second primary molar with deep carious lesion and pulp perforation risk. All teeth with deep carious lesions were examined clinically and radiographically.
The following inclusion criteria were used;
- Active carious lesion in deep dentine of primary second molars,
- Absence of clinical symptoms of irreversible pulpitis such as spontaneous pain or longtime pain against thermal and chemical stimuli,
- Absence of sensitivity to percussion or palpation, pathological mobility, swelling or fistula any discoloration except for carious lesion.
- Absence of any interradicular lesions, periapical radiolucency, pathological resorptions and pulpal calcifications.
A randomized, controlled, clinical trial was designed in a sample of 105 primary molars (35 teeth in each group) as three treatment groups: Step-wise excavation without any disinfectant (control group), step-wise excavation with CHX application (positive control group), and step-wise excavation with gaseous ozone application (experimental group).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Previously untreated, vital and asymptomatic lower primary molars with deep caries lesions considered likely to result in pulp exposure if they were treated by a single and terminal excavation
- •Positive pulp sensibility tested by an electric pulp tester and cold stimulation,
- •Mild discomfort from chemical and thermal stimuli,
- •Cooperative children and parents willing to follow the instructions and report for follow-up.
Exclusion Criteria
- •Signs of irreversible pulpitis (spontaneous pain, prolonged pain response etc.)
- •The presence of percussion or palpation sensitivity, pathological mobility, or infection symptoms like fistula or abscess or discoloration in the clinical examination,
- •Absence of normal lamina dura and periodontal range, presence of lesion, internal or external resorption or calcification in or around the root in the radiological examination,
- •Children with special health care needs.
Arms & Interventions
control
Thirty five molar teeth with deep caries lesion were selected to apply conventional two-visit indirect pulp therapy (control). The peripheral demineralized dentin and the superficial necrotic dentin were completely removed, and left some caries at the central part. The remaining caries dentin was covered with calcium hydroxide base material and cavity sealed with glass ionomer cement.
Intervention: Control (Other)
chlorhexidine digluconate
Thirty five molar teeth with deep caries lesion were selected to apply two-visit indirect pulp therapy with chlorhexidine digluconate. The peripheral demineralized dentin and the superficial necrotic dentin were completely removed, and left some caries at the central part. Following the excavation, 2% chlorhexidine digluconate was applied to the cavity for 60 seconds using a brush. According to the manufacturer instructions, puddled solution was removed with a new brush without dry to leave site moist. The remaining caries dentin was covered with calcium hydroxide base material and cavity sealed with glass ionomer cement.
Intervention: chlorhexidine digluconate (Other)
ozone
Thirty five molar teeth with deep caries lesion were selected to apply two-visit indirect pulp therapy with ozone. The peripheral demineralized dentin and the superficial necrotic dentin were completely removed, and left some caries at the central part. The cavity was exposed to gaseous ozone for 60 seconds, with an ozone delivery system. The remaining caries dentin was covered with calcium hydroxide base material and cavity sealed with glass ionomer cement to reopen 4 months later.
Intervention: ozone (Other)
Outcomes
Primary Outcomes
Changes microbiological count: from baseline to 4 months
Time Frame: Baseline and Four months later
Mutans streptococci counts were calculated.
Secondary Outcomes
- Changes characteristics of the dentin humidity: from baseline to 4 months(Baseline and Four months later)
- Changes characteristics of the dentin consistency: from baseline to 4 months(Baseline and Four months later)
- Changes characteristics of the dentin color: from baseline to 4 months(Baseline and Four months later)
Investigators
Merve AKCAY
Assoc. Prof.
Izmir Katip Celebi University