| CTRI Number |
CTRI/2022/08/044884 [Registered on: 24/08/2022] Trial Registered Prospectively |
| Last Modified On: |
17/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
“Efficacy of Antimicrobial Photodynamic Therapy using photosensitizer as an Adjunct to Non-Surgical Periodontal Therapy in controlled Type 2 Diabetes Mellitus Patients with Chronic Periodontitis. |
|
Scientific Title of Study
|
“Efficacy of Antimicrobial Photodynamic Therapy using Indocyanine Green as an Adjunct to Non-Surgical Periodontal Therapy in controlled Type 2 Diabetes Mellitus Patients with Chronic Periodontitis: A Clinical and Microbiological Study.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Agarwal |
| Designation |
Post graduate student |
| Affiliation |
JSS Dental College and Hospital |
| Address |
JSS Dental College and Hospital, JSSAHER,
Sri shivarathreeswara nagar , Bannimantap
Mysore
KARNATAKA
570015
India |
| Phone |
8801847970 |
| Fax |
|
| Email |
priyuagarwal.31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratibha Shashikumar |
| Designation |
Reader |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Department of Periodontology
JSS Dental College and Hospital, JSSAHER,
Sri shivarathreeswara nagar , Bannimantap
Department of Periodontology
JSS Dental College and Hospital, JSSAHER,
Sri shivarathreeswara nagar , Bannimantap
Mysore
KARNATAKA
570015
India |
| Phone |
9986544409 |
| Fax |
|
| Email |
drpratibhavg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Agarwal |
| Designation |
Post graduate student |
| Affiliation |
JSS Dental College and Hospital |
| Address |
JSS Dental College and Hospital, JSSAHER,
Sri shivarathreeswara nagar , Bannimantap
Mysore
KARNATAKA
570015
India |
| Phone |
8801847970 |
| Fax |
|
| Email |
priyuagarwal.31@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Dental college and Hospital
JSSAHER, SS nagar, Mysuru Karnataka 570015 |
|
|
Primary Sponsor
|
| Name |
JSSAHER |
| Address |
Department of Periodontology
JSS Dental College and Hospital, JSSAHER, SS nagar, Mysuru-570015 Karnataka |
| 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 Priyanka Agarwal |
JSS Dental College and Hospital |
Room no.9 Department of Periodontology JSS Dental College and Hospital, JSSAHER
Sri shivarathreeswara nagar , Bannimantap
Mysore
KARNATAKA |
8801847970
priyuagarwal.31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Dental College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indocyanine green with photodynamic therapy as an adjunct to Non surgical Periodontal Therapy |
Antimicrobial Photodynamic therapy using Indocyanine greean as a photosenitizer will be performed in patients diagnosed with chronic generalized periodontitis and Type 2 Diabetes Mellitus. Photodynamic therpay will be done using Diode Laser of 808nm. At baseline patients will be subjected to Scaling and root planning followed by Photodynamic therapy. Patients will be recalled after 3 months for follow up of clinical parameters and miccrobilogical analysis. The intervention is only once . |
| Comparator Agent |
Non surgical Periodontal Therapy in Type 2 diabetes mellitus patients diagnosed with Chronic Generalized Periodontitis. |
In this group only Non surgical Periodontal Therapy will be performed and compared with the test group. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age 30-60 years with confirmed diagnosis of Type-2 diabetes mellitus
• Patients with ≥20 remaining teeth with generalized moderate to severe Periodontitis.
• Patients with periodontal pocket in at least 3 teeth and depth of 4-7mm and clinical attachment level of ≥2mm.
• Patients who have given consent and are co-operative and able to come for regular follow up. |
|
| ExclusionCriteria |
| Details |
1.Pregnant women and Lactating mothers.
2.Patients with a history of antibiotic therapy in last six months of baseline therapy.
3.Patients who have undertaken any periodontal therapy in past 6 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At the end of the trial the primary outconme being expected is improvement in the Clinical Paramaters of Periodontal status, determined by Clinical Attachment level gain and reduction of Probing pocket depth. Also reduction in the colony forming units of the microbes being assessed is being expected. |
Clinical parameters will be assessed at baseline and at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Photodynamic therapy may be advantageous in the treatment of Chronic periodontitis as compared to SRP alone in Type 2 Diabetes mellitus patients. |
baseline and 3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
17/09/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Periodontitis is a multifactorial inflammatory disease associated with the loss of supporting structures of the tooth and is one of the major causes of tooth loss in adults. Periodontitis is considered sixth complication of diabetes. Periodontitis and diabetes have a two-way relationship. DM increases the risk of periodontitis, and severe periodontitis co-exists with severe DM. Hence, it is mandatory for diabetic patients to receive adequate treatment for periodontitis. Meta-analysis studies have confirmed that HbA1c reduction of around 0.4% can be anticipated following effective periodontal therapy. Intervention : 40 patients fulfilling the inclusion criteria and who have willingly given consent will be considered in the study. Test group will receive scaling and root planing along with photodynamic therapy, while control group will receive only scaling and root planing. Patient will be evaluated for the plaque index, probing pocket depth, clinical attachment level and gingival index along with the collection of subgingival plaque for microbiological assessment on the day of therapy and after 3 months. Patient will be given oral hygiene instructions and advised to avoid taking antibiotics for 3 months and recalled after 3 months. Method: In the first visit patient will be given oral hygiene instructions which will include modified Bass method of brushing and dental flossing Patients will be recalled after 7 days for baseline blood investigation (HbA1c), measurement of clinical parameters, collection of subgingival plaque samples followed by scaling and root planing in control group and scaling in root planing followed by aPDT in test group. Subgingival plaque samples will be sent for microbiological analysis. Photodynamic therapy will be done using Indocyanine green as a photosensitizer and photoactivated by the diode laser of wavelength 810nm for 60s. Patients will be evaluated for all the clinical parameters; sub gingival plaque samples will be taken and blood investigation (HbA1c) will be done after 3 months. Patients will be monitored periodically for oral hygiene maintenance and recalled for further periodontal therapy as needed. Clinical parameters to be used are: On the day of treatment and 3 months follow-up full mouth clinical parameters will be recorded. 1.Plaque index 2.Gingival index 3.Clinical Attachment Level (CAL) using a UNC-15 probe from a fixed reference point to the base of the pocket. Clinical parameters will be evaluated at the baseline and at the end of 3 months. An improvement in clinical and microbiological parameters and reduction in is being expected after 3 months in test group. |