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

Efficacy of ozone gel with chlorhexidine gel delivered locally in periodontal pockets in chronic periodontitis patients. A randomized controlled double blind clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/06/043056

Enrollment

Registered

2022-06-07

Start date

Unknown

Completion date

Unknown

Last updated

2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Primary 1. To assess and compare the gingival index and plaque index in Group A and Group B at baseline and 3 months. 2. To assess and compare pocket depth reduction and clinical attachment levels in ozone gel group and chlorhexidine gel group at 3 months. 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. Timepoint: 3 MONTHS	—

Measure

Time frame

Primary 1. To assess and compare the gingival index and plaque index in Group A and Group B at baseline and 3 months. 2. To assess and compare pocket depth reduction and clinical attachment levels in ozone gel group and chlorhexidine gel group at 3 months. 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. Timepoint: 3 MONTHS

—

Secondary

Measure	Time frame
1. to compare the primary outcome in different groups for age and genderTimepoint: 3 months	—

Countries

India

Contacts

Public ContactDr Shivani Sachdeva

RDC Pravara institute of medical sciences

dr.shivani19@gmail.com09730548805

Outcome results