Influence of Ozone Application in Stepwise Excavation Procedure of Primary Molars With Deep Carious Lesion

NCT03737201 | Completed

• 1 other identifier: 213S004-2
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Deep Caries; Ozone

Keywords

ozone; Deep Carious Lesion; Primary Molars

Outcome Measures

Primary Outcomes (3)

• Changes microbiological count: from baseline to 4 months

  Mutans streptococci counts were calculated.

  Baseline and Four months later

• Changes microbiological count: from baseline to 4 months

  Lactobacilli counts were calculated.

  Baseline and Four months later

• Changes microbiological count: from baseline to 4 months

  Total number of colony forming units counts were calculated.

  Baseline and Four months later

Secondary Outcomes (3)

• 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

Study Arms (3)

ozone

EXPERIMENTAL

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.

Other: ozone

chlorhexidine digluconate

ACTIVE COMPARATOR

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.

Other: chlorhexidine digluconate

control

ACTIVE COMPARATOR

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.

Other: Control

Interventions

ozone OTHER

In the two-visit indirect pulp therapy, due to reduce the number of bacteria remaining in the cavity, the antimicrobial agents can be used as cavity disinfectants such as ozone.

ozone

chlorhexidine digluconate OTHER

In the two-visit indirect pulp therapy, due to reduce the number of bacteria remaining in the cavity, the antimicrobial agents can be used as cavity disinfectants such as chlorhexidine digluconate.

chlorhexidine digluconate

Control OTHER

without any cavity disinfectant

control

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

MeSH Terms

Interventions

Ozone; chlorhexidine gluconate

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: randomized, three-arm parallel, two-blinded clinical trial

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 9, 2018
• Study Start: January 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: January 1, 2018
• Last Updated: November 9, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share