| CTRI Number |
CTRI/2019/05/019477 [Registered on: 31/05/2019] Trial Registered Prospectively |
| Last Modified On: |
01/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A novel drug to treat gum diseases. |
|
Scientific Title of Study
|
Evaluation of clinical and antimicrobial efficacy of chitosan nanoparticle gel (1%) as a local drug delivery in chronic periodontitis patients- a randomised controlled split mouth trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nageswaran GR |
| Designation |
Post graduate student |
| Affiliation |
Dayananda Sagar College of Dental Sciences |
| Address |
Department of Periodontics,Dayananda Sagar College of Dental Sciences, Shavige Malleshwara Hills, Kumaraswamy Layout,Bengaluru
Dayananda Sagar College of Dental Sciences, Shavige Malleshwara Hills, Kumaraswamy Layout,Bengaluru
Bangalore
KARNATAKA
560078
India |
| Phone |
8098821190 |
| Fax |
|
| Email |
g.nageswaran61@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita A M |
| Designation |
Professor and Head of the Department |
| Affiliation |
Dayananda Sagar College of Dental Sciences |
| Address |
Department of Periodontics,Dayananda Sagar College of Dental Sciences, Shavige Malleshwara Hills, Kumaraswamy Layout,Bengaluru
Dayananda Sagar College of Dental Sciences, Shavige Malleshwara Hills, Kumaraswamy Layout,Bengaluru
Bangalore
KARNATAKA
560078
India |
| Phone |
9845433660 |
| Fax |
|
| Email |
amsavita25@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Nageswaran GR |
| Designation |
Post graduate student |
| Affiliation |
Dayananda Sagar College of Dental Sciences |
| Address |
Department of Periodontics,Dayananda Sagar College of Dental Sciences, Shavige Malleshwara Hills, Kumaraswamy Layout,Bengaluru
Dayananda Sagar College of Dental Sciences, Shavige Malleshwara Hills, Kumaraswamy Layout,Bengaluru
Bangalore
KARNATAKA
560078
India |
| Phone |
8098821190 |
| Fax |
|
| Email |
g.nageswaran61@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dayananda Sagar College of Dental Sciences |
| Address |
Shavige Malleshwara Hills, Kumaraswamy Layout, Bengaluru, Karnataka-560078 |
| Type of Sponsor |
Other [Private dental college] |
|
|
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 |
| NageswaranGR |
Dayananda Sagar College of Dental Sciences |
Department of Periodontics, Dental block ,Shavige Malleshwara Hills, Kumaraswamy Layout, Bengaluru, Karnataka.
Bangalore
KARNATAKA |
8098821190
g.nageswaran61@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, DSCDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
local drug delivery |
Comparison of results obtained with local drug delivery to scaling and root planing alone.The drug will be administered through a syringe only once at the baseline. The drug will be administered till the entire depth of pocket is filled with the drug. |
| Comparator Agent |
Scaling and root planing |
Comparing the results obtained with local drug delivery with those obtained with scaling and root planing |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Probing pocket depth 5mm to 8mm.
Clinical attachment level of 3mm.
Vertical bone loss greater than 3mm on digital radiographs |
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases.
Patients who have undergone periodontal treatment in last 6 months.
Pregnant and lactating mothers.
Smokers, alcoholics, drug abusers. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the antimicrobial efficacy of Chitosan nanoparticle gel (1%) as local drug delivery against periopathogens Porphyromonas gingivalis, Tanerella forsythia. |
6 weeks interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival index,plaque index, |
6 week interval |
|
|
Target Sample Size
|
Total Sample Size="29"
Sample Size from India="29"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/06/2019 |
| Date of Study Completion (India) |
12/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Manuscript under preparation. Will be sent for publication after reviewed by all the contributing authors |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A split mouth study was conducted wherein 29 patients were selected and the results obtained with local drug delivery were compared with those obtained with those obtained with scaling and root planing.Scaling and root planing is the commonly employed procedure for the treatment of periodontal diseases.However tissue invasive bacteria may still be present and harboring the periodontal tissues.Hence the use of adjunctive antimicrobial therapy is advised.There are many commercially available agents for local drug delivery but are associated with disadvantages like antimicrobial resistance, lack of substantivity etc. Chitosan is a drug which once administered will exhibit its effect for extended period of time and hence iwas tried against the periodontal pathogens |