| CTRI Number |
CTRI/2017/08/009193 [Registered on: 01/08/2017] Trial Registered Prospectively |
| Last Modified On: |
16/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A clinical trial to study the effect of vitamin D in patients with gum diseases. |
|
Scientific Title of Study
|
A Randomized Controlled Trial for reinforcement of epithelial barrier function by vitamin D induction of the antimicrobial peptide cathelicidine. A novel therapeutic approach in Chronic periodontitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarita Joshi Narayan |
| Designation |
Professor and HOD |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences and Hospital |
| Address |
Department of Periodontics, 3rd Floor, RGC Campus, Cholanagar, Hebbal, RT Nagar Post, Bangalore.
Bangalore
KARNATAKA
5600032
India |
| Phone |
9845112838 |
| Fax |
|
| Email |
drsaritanarayan@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Bose |
| Designation |
Senior Lecturer |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences and Hospital |
| Address |
Department of Periodontics, 3rd Floor, RGC Campus, Cholanagar, Hebbal, RT Nagar Post, Bangalore.
Bangalore
KARNATAKA
5600032
India |
| Phone |
8105851209 |
| Fax |
|
| Email |
dr.aditi2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi Bose |
| Designation |
Senior Lecturer |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences and Hospital |
| Address |
Department of Periodontics, 3rd Floor, RGC Campus, Cholanagar, Hebbal, RT Nagar Post, Bangalore.
Bangalore
KARNATAKA
5600032
India |
| Phone |
8105851209 |
| Fax |
|
| Email |
dr.aditi2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi University of Health Sciences.
4th T Block, Jayanagar, Bengaluru, Karnataka 560041 |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi University of Health Sciences |
| Address |
Jaynagar, 4th T Block, Bangalore, Karnataka, India. |
| Type of Sponsor |
Research institution |
|
|
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 Sarita Joshi Narayan |
Sri Rajiv Gandhi College of Dental Sciences and Hospital |
Department of Periodontics. Room Number 12, Third Floor, RGC Campus, Cholanagar,R T Nagar Post.
Bangalore
KARNATAKA |
9845112838
drsaritanarayan@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Rajiv Gandhi College of Dental Sciences and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Chronic Periodontitis, (1) ICD-10 Condition: M272||Inflammatory conditions of jaws, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Subjects who have not been prescribed Vitamin D |
Subjects undergoing only scaling and root planing |
| Intervention |
Vitamin D tablets |
2000IU vitamin D tablets daily for 3 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria :
1.Study subjects should be >25 years of age.
2.Patients suffering from chronic periodontitis i.e.
a)Bleeding on probing
b)Probing pocket depth of ≥ 5 mm
c)Clinical attachment loss of ≥ 3 mm
3.Patients should be vitamin D sufficient (serum levels 30ng/ml and above) according to vitamin D council.
4.Systemically healthy individuals with minimum 20 teeth in occlusion.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
1.Patients with systemic diseases that can impair immune response such as diabetes mellitus, HIV, immunological disorder and hepatitis.
2.Patients on any systemic antibiotics, NSAIDS, steroid therapy and any other drugs which is known to affect the periodontal status.
3.Smokers and former smokers are excluded from the study.
4.Patients who have received periodontal treatment in the preceding year or who have taken antibiotics within the previous 3 months.
5.Pregnant or lactating women and those taking oral contraceptive drugs.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in GCF cathelicidine levels. |
90 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in epithelial barrier function |
90 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/01/2018 |
| Date of Study Completion (India) |
13/08/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Chronic Periodontitis is an inflammatory destructive disease of the periodontium resulting in damage to the epithelial barrier , the first line of defence which prevents the entry of microorganisms.Untreated periodontitis progressively results in tooth mortality which has significant social and economic burden on the patients.With shifting paradigms in health care facilities from cure to prevention much emphasis has been laid upon prevention of disease process at the primary level.There are 3 barriers against infection namely physical,chemical and immunological.The chemical barrier mainly comprises of anti microbial peptides (AMPs) which are endogenously produced antibiotics. Defensins and Cathelicidines are the most powerful AMPs detected in oral cavity.
The link between upscaling of AMP function and vitamin D is well established.Thus an increase in vitamin D should significantly improve the chemical barrier function by increasing AMPs. This study intends to explore an economically viable , easily available and a well accepted molecule like vitamin D in primary prevention of chronic periodontitis by reinforcing the epithelial barrier through increased action of Cathelicidine thus reducing a cascade of events which results in tooth mortality. |