| CTRI Number |
CTRI/2024/06/069650 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative evaluation of scaling and root planning with photobiomodulation therapy on telomere length in patients with periodontitis. |
|
Scientific Title of Study
|
Comparative evaluation of SRP with and without photobiomodulation on telomere length in patients with periodontitis- a clinical molecular study. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinitha Saravanan |
| Designation |
post graduate student |
| Affiliation |
Sharavathi dental college and hospital, shimoga |
| Address |
Department of periodontics
sharavathi dental college and hospital, shimoga
karnataka
Shimoga
KARNATAKA
577205
India |
| Phone |
7795640184 |
| Fax |
|
| Email |
vinitha2212@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSoumya BG |
| Designation |
Professor |
| Affiliation |
Sharavathi dental college and hospital,shimoga |
| Address |
department of periodontics
sharavathi dental college and hospital
shimoga
karnataka
Shimoga
KARNATAKA
577205
India |
| Phone |
7795640184 |
| Fax |
|
| Email |
drbgsoumya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSoumya BG |
| Designation |
Professor |
| Affiliation |
Sharavathi dental college and hospital,shimoga |
| Address |
department of periodontics
sharavathi dental college and hospital
shimoga
karnataka
KARNATAKA
577205
India |
| Phone |
7795640184 |
| Fax |
|
| Email |
drbgsoumya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sharavathi Dental college and hospital,Shimoga.Karnataka 577205 |
|
|
Primary Sponsor
|
| Name |
Vinitha Saravanan |
| Address |
Department of periodontics
sharavathi dental collega and hospital
shimoga
karnataka 577205 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DrVinitha Saravanan |
Sharavathi dental college and hospital |
Department of periodontology
Sharavathi dental college and hospital
NH 206, Alkola,T.H Road, Karnataka 577205
Shimoga
KARNATAKA |
7795640184
vinitha2212@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sharavathi ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
laser therapy |
photobiomodulation therapy at 810nm wavelength for 40seconds at 4joules of energy and 100mW.
It is done at 3sessions at intervals of every 24-48hours time period after scaling and root planning. |
| Comparator Agent |
scaling and root planning |
patients undergo scaling and at after 1 week root planning on all quadrants |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from stage II Grade A periodontitis
Possessing atleast 20 teeth
Clinical Attachment Loss ≥ 3mm
Age Range of 35-50 years
Presence of local factors and bleeding on probing
|
|
| ExclusionCriteria |
| Details |
Patients with systemic disease
Patients who have undergone antimicrobial and/or antibiotic therapy in the last 3 months
Lactating and pregnant mothers
Smokers , alcoholic and / or any other recreational drug
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to measure the length of telomere in human DNA before and after treatment |
at baseline
at 21days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| decrease in the loss of length of telomere in DNA |
at baseline and at 21days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 1 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vinitha2212@gmail.com].
- For how long will this data be available start date provided 01-08-2024 and end date provided 01-08-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
In this study,5ml of blood samples are drawn at baseline and on 21days.Patients are divided into two groups who shall undergo scaling and root planing while the patients of experimental group undergo photobiomodulation therapy along with scaling and root planing. Patients suffering from chronic generalized periodontitis often show characteristics of exaggerated inflammation that are associated with untimely reduction in the length of telomere in human DNA which is also co-related to aging and disorders such as alzhimers and diabetes. Photobiomodulation therapy reduces the inflammatort factors and may also stop the untimely reduction of DNA length. Thus proving to be beneficial to the patient in the long run. |