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

Phase 3

Not yet recruiting

• Conditions: Other infectious disease, (2) ICD-10 Condition: B999||Unspecified infectious disease,

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

Brief Summary

This study is a randomized, double blind, single centre, parallel group, Phase III clinical study to evaluate treatment outcome for two groups; first is the OZONE GEL (experimental /test drug) and second is the CHLOREXIDINE GROUP (gold standard). The aim of the study is to evaluate the which has better treatment outcome in reduction of periodontal pocket depth and decreasing colony forming units in chronic periodontitis patients. The primary variables will be age, gender, probing pocket depth, gain in the attachment levels, plaque index, modified gingival index, colony forming units, recurrence and healing.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-03-06
• Study Start: 2022-06-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

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 3–4 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	3 MONTHS
1.To assess and compare the gingival index and plaque index in Group A and Group B at baseline and 3 months.	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 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.	3 MONTHS

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rural Dental College, Pravara Institute of Medical Sciences; 🇮🇳 Ahmadnagar, MAHARASHTRA, India

Rural Dental College, Pravara Institute of Medical Sciences

🇮🇳Ahmadnagar, MAHARASHTRA, India

DR SHIVANI SACHDEVA

Principal investigator

9730548805

dr.shivani19@gmail.com