STUDY TO COMPARE THE CLINICAL OUTCOME OF OZONE GEL VERSUS CHLORHEXIDINE GEL IN PERIODONTITIS PATIENTS.

Phase 3

• Conditions: Health Condition 1: B998- Other infectious diseaseHealth Condition 2: B999- Unspecified infectious disease

• Registration Number: CTRI/2022/06/043056
• Lead Sponsor: SHIVANI SACHDEVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Systemically healthy subjects with probing pocket depth of 3-7mm

2.Patients exhibited 1-2 mm of clinical attachment loss

3.Horizontal bone loss with no furcation involvement

4.Age range of 20-50 years old of any gender.

5.Patients willing to give written and informed consent before any study specific procedure.

6.Hemodynamically stable patients

Exclusion Criteria

1.Patients requiring periodontal flap surgery

2.Recurrent history of periodontal infections and wearing orthodontic brackets.

3.Use of antibiotics in the past 3â??4 weeks

4.History of use of gel application or use of mouthwash within last month

5.Patient with acute necrotizing ulcerative gingivitis, acute herpetic gingivostomatitis, allergic gingivitis, gingivitis associated with skin diseases, gingivitis associated with endocrine-metabolic disturbances, gingivitis associated with hematologic-immunologic disturbances, gingival enlargement associated with medications, gingival tumors.

5.Active Hepatitis B virus or Hepatitis C virus, HIV/AIDS

6.Subjects who having psychiatry/physical morbidity and cannot perform proper manual brushing

7.Individuals with known systemic disease

8.Smokers

9.Pregnant, lactating women, allergic to ozone gel and the patients with history of any previous periodontal or antibiotic therapy.

Subjects having any kind of disorder that compromises the ability of subject to think rationally and/or prevent from completing the study as per protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary <br/ ><br>1.To assess and compare the gingival index and plaque index in Group A and Group B at baseline and 3 months. <br/ ><br>2.To assess and compare pocket depth reduction and clinical attachment levels in ozone gel group and chlorhexidine gel group at 3 months. <br/ ><br>3.To assess and compare the colony forming units (CFU) of E.coli in plaque samples at baseline and 3 months GROUP A and GROUP B. <br/ ><br>Timepoint: <br/ ><br>3 MONTHS

Secondary Outcome Measures

Name	Time	Method
1. to compare the primary outcome in different groups for age and genderTimepoint: 3 months