Influence of Ozone Application in Stepwise Excavation Procedure of Primary Molars With Deep Cario… (NCT03737201) | Clinical Trial Compass
CompletedNot Applicable
Influence of Ozone Application in Stepwise Excavation Procedure of Primary Molars With Deep Carious Lesion
105 participantsStarted 2017-01-01
Plain-language 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.
Who can participate
Age range
6 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes microbiological count: from baseline to 4 months
Timeframe: Baseline and Four months later
2
Changes microbiological count: from baseline to 4 months
Timeframe: Baseline and Four months later
3
Changes microbiological count: from baseline to 4 months