Evaluation and comparison of the efficacy of locally delivered ocimum sanctum gel and 8-Hydroxydeoxyguanosine levels in gingival crevicular fluid in subjects with chronic periodontitis before and after scaling and root planning therapy.

Phase 2

Recruiting

Conditions: Healthy and Smoker patients with Chronic periodontitis and Non Smoker patients with Chronic periodontitis

Registration Number: CTRI/2017/12/010748

Lead Sponsor: No sponsor

Brief Summary: This is randomized control trial Study is conducted to evaluateO-HdGlevels in periodontally healthy Smoker chronic periodontitis and non smokerchronicperiodontitis patientsA total of 50 subjects with age 30 years andabove including both male and femalevisiting the Department of Periodontics at VSPM Dental College and research centreNagpur will be recruited

Studywas devided into 3

**GroupI**Periodontally and systemically healthy patients

**Group II** Smoker chronic periodontitis patients

**Group III** Non smoker chronic periodontitispatients

A brief description of entire procedure will be given to every patientbefore starting procedure. Written informed consent will be taken from thepatients who wish to enroll in the study

For all subjects following periodontal parameters will be recorded:

1       Plaque index (Silness and Loe 1964)

2       Gingival index (Loe and Silness 1963)

3       Sulcular bleeding index (Muhlemann 1975)

4       Probing pocket depth

5       Clinical Attachment loss

Scaling and root planning along with application of 10 % Tulsi gel willbe performed in smokers and non smoker groups on one side and on the other sideonly SRP will be performed

A re-evaluation examination willbe performed at 1 and 3 months following the completion of initial therapyAfter clinical examination GCFsampleswould be collected and GCF OHdG levels will be evaluated using Enzyme Linked ImmunosorbentAssay kit

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 50

Inclusion Criteria

Group I Periodontally healthy subjects Gingival index equel to 0 Periodontal pocket depth greater than equal to 3 mm and clinical attachment level equal to 0 Group II SmokerSubjects with mild to moderate Chronic periodontitis Gingival Index greater than or equal to 1mm Periodontal pocket depth than or equal to 5mm and Clinical attachment levelgreater than or equal to 3mm and H/O smoking at least 7-8 cigarettes per day for last 3 year GroupIII Non smoker subjects with mild to moderate Chronic periodontitis gingival index 1pocket depth of greater than or equal to 5mm and clinical attachment level greater than or equal to 3mm.

Exclusion Criteria

1Medically compromised patients 2Patient with systemic disease 3Pregnant and lactating mother 4Patient received periodontal therapy antibiotics or antioxidant therapy within 6 months 5Patient with acute illness.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To cheak Improvement in periodontal status and reduction of periodontal pocket depth and gain clinical attachment level in smoker and non smoker periodontitis patient	2 year

Secondary Outcome Measures

Name	Time	Method
To compare the efficacy of locally delivered ocimum sanctum gel and 8-OHdG level in gingival crevicular fluid in smokers and non smokers with chronic periodontitis patients	2 year

Trial Locations

Locations (1): VSPM Dental College and Research Center
🇮🇳
Nagpur, MAHARASHTRA, India
VSPM Dental College and Research Center
🇮🇳Nagpur, MAHARASHTRA, India
Dr Shweta Maske
Principal investigator
8805795569
shweta.maske17@gmail.com