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Effect of Ozone Gel on Treatment of Chronic Periodontitis

Primary Purpose

Periodontal Diseases

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

scaling and root planing

placebo gel

Ozonated olive oil gel

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring Ozone gel, Antioxidants, Chronic periodontitis, Superoxide dismutase

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

The participant's age ranged between 30 and 60 years.
All of the patients suffered from chronic periodontitis with attachment loss ≥ 5mm.
Willingness to participate and sign the informed consent.

Exclusion Criteria:

Any systemic disease that affect the periodontium.
Pregnancy, lactation, postmenopausal women
People who take anti-inflammatory drugs, antibiotics or vitamins within the previous 3 month.
People who use mouth washes regularly
Heavy smoking (> 10 cigarettes/day)
History of alcohol abuse.
Participation in other clinical trials.

Sites / Locations

October 6 University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo gel

Ozonated olive oil gel

Arm Description

scaling and root planing with placebo gel

scaling and root planing with Ozonated olive oil gel

Outcomes

Primary Outcome Measures

Superoxide dismutase activity

Superoxide dismutase activity in the gingival crevicular fluid was carried out at baseline, 1, 3 and 6 months post treatment.

Secondary Outcome Measures

Plaque Index

plaque index was recorded at baseline and at 1, 3 and 6 months post treatment.

Gingival index

Gingival index was recorded at base line,1,3,6 months post treatment

Probing pocket depth

Probing pocket depth was recorded at base line, 1, 3, 6 months post treatment

Clinical attachment level

Clinical attachment level was recorded at baseline, 1, 3 and 6 months post treatment

Bone density

Bone density was carried out using Digora software (Digora system, Soredex, Orion Corp., Finland) at baseline and 6 months

Full Information

NCT ID

NCT02066337

First Posted

January 30, 2014

Last Updated

February 19, 2014

Sponsor

October 6 University

1. Study Identification

Unique Protocol Identification Number

NCT02066337

Brief Title

Effect of Ozone Gel on Treatment of Chronic Periodontitis

Official Title

Effect of Ozone Gel on Alveolar Bone Density and Superoxide Dismutase in Chronic Periodontitis: A Randomized Controlled Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

October 6 University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To evaluate the efficacy of locally delivered ozone gel as an adjunct to conventional periodontal therapy on selected clinical parameters as well as alveolar bone density (BD) and superoxide dismutase (SOD) activity in patient with chronic periodontitis.

Detailed Description

In this study, the investigators tested the effect of ozone gel as a local delivery system in treatment of chronic periodontitis in term of probing pocket depth reduction, mean gain in clinical attachment level, a more rise in BD values as well as greater reduction in SOD activity compared to scaling and root planing (SRP) alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontal Diseases

Keywords

Ozone gel, Antioxidants, Chronic periodontitis, Superoxide dismutase

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

placebo gel

Arm Type

Placebo Comparator

Arm Description

scaling and root planing with placebo gel

Arm Title

Ozonated olive oil gel

Arm Type

Active Comparator

Arm Description

scaling and root planing with Ozonated olive oil gel

Intervention Type

Procedure

Intervention Name(s)

scaling and root planing

Intervention Type

Drug

Intervention Name(s)

placebo gel

Intervention Type

Drug

Intervention Name(s)

Ozonated olive oil gel

Other Intervention Name(s)

Ozonated olive oil gel = Oxactiv gel

Primary Outcome Measure Information:

Title

Superoxide dismutase activity

Description

Superoxide dismutase activity in the gingival crevicular fluid was carried out at baseline, 1, 3 and 6 months post treatment.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Plaque Index

Description

plaque index was recorded at baseline and at 1, 3 and 6 months post treatment.

Time Frame

6 months

Title

Gingival index

Description

Gingival index was recorded at base line,1,3,6 months post treatment

Time Frame

6 months

Title

Probing pocket depth

Description

Probing pocket depth was recorded at base line, 1, 3, 6 months post treatment

Time Frame

6 months

Title

Clinical attachment level

Description

Clinical attachment level was recorded at baseline, 1, 3 and 6 months post treatment

Time Frame

6 months

Title

Bone density

Description

Bone density was carried out using Digora software (Digora system, Soredex, Orion Corp., Finland) at baseline and 6 months

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The participant's age ranged between 30 and 60 years. All of the patients suffered from chronic periodontitis with attachment loss ≥ 5mm. Willingness to participate and sign the informed consent. Exclusion Criteria: Any systemic disease that affect the periodontium. Pregnancy, lactation, postmenopausal women People who take anti-inflammatory drugs, antibiotics or vitamins within the previous 3 month. People who use mouth washes regularly Heavy smoking (> 10 cigarettes/day) History of alcohol abuse. Participation in other clinical trials.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Enas Elgendy, ph.D

Organizational Affiliation

October 6 University

Official's Role

Principal Investigator

Facility Information:

Facility Name

October 6 University

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

Effect of Ozone Gel on Treatment of Chronic Periodontitis

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