NCT07604636

Brief Summary

Patients with residual periodontal pockets following non-surgical periodontal therapy remain at risk for disease progression and may require further periodontal surgery. Repeated scaling and root planing (SRP) is commonly used for residual pockets; however, complete elimination of periodontal pathogens is often difficult to achieve. Ozone therapy has antimicrobial, anti-inflammatory, and wound-healing properties that may improve periodontal treatment outcomes. The aim of this randomized controlled clinical trial is to clinically and microbiologically evaluate the adjunctive effects of gaseous ozone application during repeated SRP for residual periodontal pockets in patients undergoing periodontal maintenance therapy. Twenty-six patients diagnosed with stage III or IV periodontitis presenting with residual periodontal pockets ≥5 mm with bleeding on probing will be included. Residual pockets will be randomly assigned to either repeated SRP alone (control group) or repeated SRP combined with ozone application (test group). Clinical periodontal parameters and microbiological findings will be evaluated at baseline, 3 months, and 6 months after treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

May 17, 2026

Last Update Submit

May 17, 2026

Conditions

Keywords

Ozone TherapyScaling and Root PlaningPeriodontal MaintenanceResidual PocketPocket ClosurePeriodontal DebridementBANA TestPeriodontal Pathogens

Outcome Measures

Primary Outcomes (1)

  • Change in Probing Depth

    Assessment of changes in periodontal probing depth (PD) in residual periodontal pockets following repeated scaling and root planing with or without adjunctive gaseous ozone application.

    Baseline, 3 months, and 6 months after treatment

Secondary Outcomes (3)

  • Change in Clinical Attachment Level

    Baseline, 3 months, and 6 months after treatment

  • Bleeding on Probing

    Baseline, 3 months, and 6 months after treatment

  • BANA Test Results

    Baseline, 3 months, and 6 months after treatment

Study Arms (2)

Repeated Scaling and Root Planing

ACTIVE COMPARATOR

Residual periodontal pockets received repeated scaling and root planing alone following periodontal maintenance therapy.

Procedure: Scaling and Root Planing

Repeated Scaling and Root Planing Plus Ozone

EXPERIMENTAL

Residual periodontal pockets received repeated scaling and root planing combined with gaseous ozone application following periodontal maintenance therapy.

Procedure: Scaling and Root PlaningDevice: Gaseous Ozone Application

Interventions

Repeated scaling and root planing of residual periodontal pockets was performed using mini-curettes under local anesthesia following periodontal maintenance therapy.

Also known as: Subgingival Reinstrumentation
Repeated Scaling and Root PlaningRepeated Scaling and Root Planing Plus Ozone

Gaseous ozone was applied into residual periodontal pockets using the OzoneDTA device with a periodontal probe tip according to the manufacturer's instructions.

Also known as: Ozone Therapy
Repeated Scaling and Root Planing Plus Ozone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Systemically healthy individuals
  • Patients diagnosed with stage III or IV periodontitis
  • Patients undergoing periodontal maintenance therapy
  • Presence of at least two residual periodontal pockets ≥5 mm with bleeding on probing
  • Presence of radiographic bone loss ≥3 mm
  • Plaque Index (PI) \<1 before treatment
  • Ability and willingness to attend all follow-up visits
  • Written informed consent obtained

You may not qualify if:

  • Presence of systemic diseases affecting periodontal healing
  • Pregnancy or lactation
  • Tobacco or alcohol use
  • Use of medications affecting periodontal tissues or wound healing
  • Periodontal treatment within the previous 6 months
  • Presence of carious lesions or periapical pathology on selected teeth
  • Furcation involvement
  • Tooth mobility ≥ degree 1
  • Restorations on selected teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Faculty of Dentistry, Department of Periodontology

Erzurum, Turkey (Türkiye)

Location

Related Publications (1)

  • Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.

MeSH Terms

Conditions

PeriodontitisPeriodontal Pocket

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Clinical and microbiological measurements were performed by a blinded examiner who was not involved in treatment procedures.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This study was designed as a split-mouth randomized controlled clinical trial in which residual periodontal pockets within the same participant were randomly assigned to either repeated scaling and root planing alone or repeated scaling and root planing combined with gaseous ozone application.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 17, 2026

First Posted

May 22, 2026

Study Start

March 15, 2024

Primary Completion

December 15, 2024

Study Completion

January 20, 2025

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly available due to privacy and confidentiality considerations.

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