Deep Caries Clinical Trial
Official title:
Ozone Application in Stepwise Excavation
Verified date | November 2018 |
Source | Izmir Katip Celebi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 105 |
Est. completion date | January 1, 2018 |
Est. primary completion date | July 1, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 10 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Izmir Katip Celebi University | The Scientific and Technological Research Council of Turkey |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes microbiological count: from baseline to 4 months | Mutans streptococci counts were calculated. | Baseline and Four months later | |
Primary | Changes microbiological count: from baseline to 4 months | Lactobacilli counts were calculated. | Baseline and Four months later | |
Primary | Changes microbiological count: from baseline to 4 months | Total number of colony forming units counts were calculated. | Baseline and Four months later | |
Secondary | Changes characteristics of the dentin humidity: from baseline to 4 months | Dentine was probed and if moisture leakage was occurred, it was classified as wet or if did not it would be classified as dry. | Baseline and Four months later | |
Secondary | Changes characteristics of the dentin consistency: from baseline to 4 months | The consistency of dentin was determined by probing and classified as; very soft, soft, medium hard and hard. | Baseline and Four months later | |
Secondary | Changes characteristics of the dentin color: from baseline to 4 months | The colour of dentin was classified as, light yellow, yellow, light brown, dark brown/black. | Baseline and Four months later |
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