| CTRI Number |
CTRI/2017/12/010748 [Registered on: 05/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
15/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
Evaluation and comparison of the efficacy of locally delivered ocimum sanctum gel and 8-Hydroxydeoxyguanosine levels in gingival crevicular fluid in smoker and non smoker with chronic periodontitis patients before and after phase I therapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shweta Maske |
| Designation |
PG Student |
| Affiliation |
VSPM dental college |
| Address |
Dept of Periodontics and Implantology
VSPM Dental College and Research Centre
Digdoh Hills Hingna Road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8805795569 |
| Fax |
|
| Email |
shweta.maske17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surekha Rathod |
| Designation |
Professor and Guide |
| Affiliation |
VSPM Dental College |
| Address |
Dept of Periodontics and Implantology
VSPM Dental College and Research Centre
Digdoh Hills Hingna Road
Nagpur
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhay Kolte |
| Designation |
Professor Head of department and Guide |
| Affiliation |
VSPM Dental College and Research Centre |
| Address |
Department of Periodontics and Implantology
VSPM Dental College and Research Centre
Digdoh Hills Hingna Road
Nagpur 440019
Maharashtra
India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
No sponsor |
| Address |
NONE |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shweta Maske |
VSPM Dental College and Research Center |
Department of Periodontics
room no 104
VSPM dental college and research center Nagpur.
Nagpur
MAHARASHTRA |
8805795569
shweta.maske17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VSPM Dental College and Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Healthy and Smoker patients with Chronic periodontitis and Non Smoker patients with Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
plane scaling and root planning |
Application of 10 % Tulsi gel in group I and group II patient of one side and plane scaling and root planing on other side in group I and group II patients |
| Intervention |
Scaling and root planing and local drug delivery. |
Topical Application of 10 % Tulsi gel in group I and group II patient of one side on baseline and plane scaling and root planing on other side in group I and group II patients |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
1 Medically compromised patients
2 Patient with systemic disease
3 Pregnant and lactating mother
4 Patient received periodontal therapy antibiotics or antioxidant therapy within 6 months
5 Patient with acute illness |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
08/03/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet have publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is randomized control trial Study is conducted to evaluateO-HdGlevels in periodontally healthy Smoker chronic periodontitis and non smokerchronic
periodontitis patientsA total of 50 subjects with age 30 years and
above including both male and female
visiting the Department of Periodontics at VSPM Dental College and research centre
Nagpur will be recruited
Study
was devided into 3 Group
I Periodontally and systemically healthy patients
Group II Smoker chronic periodontitis patients
Group III Non smoker chronic periodontitis
patients
A brief description of entire procedure will be given to every patient
before starting procedure. Written informed consent will be taken from the
patients 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 will
be performed in smokers and non smoker groups on one side and on the other side
only SRP will be performed
A re-evaluation examination will
be performed at 1 and 3 months following the completion of initial therapyAfter clinical examination GCFsamples
would be collected and GCF OHdG levels will be evaluated using Enzyme Linked Immunosorbent
Assay kit |