Ozone Application in Periodontal Treatment

NCT ID: NCT05971706

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-27

Study Completion Date

2025-11-15

Brief Summary

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This clinical trial aims to evaluate the clinical, biochemical and microbiological efficacy of ozone treatment as an adjunct to nonsurgical periodontal treatment (NSPT) in periodontitis patients. The main question it aims to answer is:

• Is the application of gaseous ozone, as an adjunct to NSPT, to periodontal pockets in patients with periodontitis alters the clinical periodontal parameters, gingival crevicular fluid levels of inflammatory cytokines, and periodontal pathogens compared to NSPT alone? The study will be performed according to a split-mouth design, the contralateral quadrants with similar periodontal status in each patient will be randomly allocated to one of the following two different treatment modalities.

Participants will be applied NSPT consisting of supra and subgingival debridement.

* NSPT will be applied alone in one quadrant
* In addition to NSPT, ozone therapy procedures were performed using a device at contralateral sites.

Researchers will compare the sites with and without ozone therapy in addition to NSPT to see if ozone therapy adjunct to the NSPT affects clinical, biochemical, and microbiological changes

Detailed Description

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Conditions

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Periodontitis

Keywords

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periodontitis ozone treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ozone

Gaseous ozone was applied immediately after non-surgical periodontal treatment

Group Type EXPERIMENTAL

Ozone therapy using a device (Ozone DTA Ozone Generator, Denta Tec Dental AS, Norway)

Intervention Type DEVICE

Ozone therapy procedures will be performed immediately after non-surgical periodontal treatment and three times (every third day) within one week using a device equipped with a periodontal tip according to equipment producer recommendations. The periodontal tip will be halted 1 mm short of the pocket depth. Ozone will be applied only to the pockets; which depth is equal to or greater than 5 mm. Ozone application time to the pockets will be 30 seconds at a fixed concentration of 2,100 ppm (80% oxygen) through a connected handpiece.

Non-surgical periodontal treatment

Intervention Type PROCEDURE

Non-surgical periodontal treatment consists of oral hygiene instructions, full mouth supragingival scaling using hand instruments, ultrasonic devices, polishing, and subgingival debridement under local anesthesia with sharp Gracey and Universal curettes and ultrasonic instruments in a single appointment.

control

Only non-surgical periodontal treatment was applied

Group Type ACTIVE_COMPARATOR

Non-surgical periodontal treatment

Intervention Type PROCEDURE

Non-surgical periodontal treatment consists of oral hygiene instructions, full mouth supragingival scaling using hand instruments, ultrasonic devices, polishing, and subgingival debridement under local anesthesia with sharp Gracey and Universal curettes and ultrasonic instruments in a single appointment.

Interventions

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Ozone therapy using a device (Ozone DTA Ozone Generator, Denta Tec Dental AS, Norway)

Ozone therapy procedures will be performed immediately after non-surgical periodontal treatment and three times (every third day) within one week using a device equipped with a periodontal tip according to equipment producer recommendations. The periodontal tip will be halted 1 mm short of the pocket depth. Ozone will be applied only to the pockets; which depth is equal to or greater than 5 mm. Ozone application time to the pockets will be 30 seconds at a fixed concentration of 2,100 ppm (80% oxygen) through a connected handpiece.

Intervention Type DEVICE

Non-surgical periodontal treatment

Non-surgical periodontal treatment consists of oral hygiene instructions, full mouth supragingival scaling using hand instruments, ultrasonic devices, polishing, and subgingival debridement under local anesthesia with sharp Gracey and Universal curettes and ultrasonic instruments in a single appointment.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* systemically healthy
* no periodontal treatment within 6 months from the enrollment date
* no antibiotics or anti-inflammatory medication taken within 6 months from the enrollment date
* no smokers
* no pregnancy or lactation at the time of the stud
* no contraindication for periodontal treatment and ozone application

Exclusion Criteria

* Participants will be excluded if they had less than 20 teeth, partial dentures, or fixed prosthodontics.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biruni University

OTHER

Sponsor Role lead

Responsible Party

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Burcu KARADUMAN

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Biruni University

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Burcu Karaduman, Professor

Role: CONTACT

Phone: +905323763366

Email: [email protected]

Facility Contacts

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Burcu Karaduman

Role: primary

Other Identifiers

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Ozone

Identifier Type: -

Identifier Source: org_study_id