| CTRI Number |
CTRI/2014/05/004636 [Registered on: 29/05/2014] Trial Registered Retrospectively |
| Last Modified On: |
02/12/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of gum disease using photodynamic therapy |
|
Scientific Title of Study
|
Efficacy of photodynamic therapy in the management of chronic localized periodontitis in terms of clinical attachment level,fluorescence spectrum and periodontopathogenic bacterial counts-A randomized controlled single blinded clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrBetsy Joseph |
| Designation |
senior lecturer |
| Affiliation |
Noorul islam college of dental science, kerala university |
| Address |
KP 1/11,
Kamalnagar,Nalanchira PO
Thiruvananthapuram
KERALA
695015
India |
| Phone |
04712590138 |
| Fax |
|
| Email |
jobets121@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrBeena VT |
| Designation |
Professor and Head |
| Affiliation |
Kerala University |
| Address |
Prof & HOD
Department of Oral pathology, Govt Dental College
Not Applicable
N/A
695005
India |
| Phone |
919847150407 |
| Fax |
|
| Email |
drvtbeena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Betsy Joseph |
| Designation |
Reader |
| Affiliation |
Department of Periodontics,Noorul Islam College of Dental Science , Neyyatinkara,Trivandrum |
| Address |
Paul Villa , KP 1/11,Kamalnagar, Nalanchira PO, Trivandrum
Thiruvananthapuram
KERALA
695015
India |
| Phone |
919037171356 |
| Fax |
|
| Email |
jobets121@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Science Technology Govt of India |
| Address |
Department of Science & Technology,
Technology Bhavan, New Mehrauli Road,
New Delhi - 110016 |
| Type of Sponsor |
Government funding agency |
|
|
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 Presanthila Janam |
Department of Periodontics |
Government Dental College
Trivandrum
Thiruvananthapuram
KERALA |
919387803891
pjanamperio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee , Govt. Dental College,Trivandrum |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Periodontal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
scaling |
|
| Intervention |
scaling ,photodynamic therapy |
|
| Intervention |
Scaling and root planing and Photodynamic therapy |
compared with scaling and root planing at 1 month, 3 months and 6 months recall visits |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
Selected patients should have a minimum of 20 teeth.
Age group: between 18 to 65 years, both males and females.
Has had no periodontal therapy in the 6 months prior to the initiation of study treatment
Single rooted teeth with no recession |
|
| ExclusionCriteria |
| Details |
Periodontal therapy in last 6 months
Systemic antibiotics within last 3 months
Pregnancy lactation Smoking Known allergy to Methylene Blue/ Toludine blue Abscess of the periodontium |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
pocket probing depth
|
1 month
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
clinical attachment level
gingival index
plaque index
fluorescence spectrum
periodontpathogenic bacterial counts |
1 month
3 months
6 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2011 |
| Date of Study Completion (India) |
Date Missing |
| 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
|
. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
this study is a randomized single blinded controlled clinical trial comparing the efficacy of photodynamic therapy to conventional Scaling and root planing in 160 patients. the primary outcome measures will be ocket probing depth at 1 month, 3 months and 6 months. the secondary outcome clinical attachment levels , gingival index ,plaque index . fluorescence spectrum and periodontopathogenic bacterial counts. at the same intervals. |