| CTRI Number |
CTRI/2024/07/070096 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
When combined with routine non-surgical gum therapy, the use of lasers can help reduce harmful bacteria in the mouths of people with type 2 diabetes.
|
|
Scientific Title of Study
|
Effect of diode laser application as an adjunct to non-surgical periodontal therapy on the reduction of red complex microorganisms in type 2 diabetic patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sherina Iqbal |
| Designation |
Postgraduate resident |
| Affiliation |
Mar Baselios Dental College |
| Address |
Room no 11
Department of Periodontics,
Mar Baselios Dental College,
Thangalum.
Ernakulam
KERALA
686691
India |
| Phone |
9995042580 |
| Fax |
|
| Email |
sherinaiqbal123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Majo Ambooken |
| Designation |
Professor and Head of the Department |
| Affiliation |
Mar Baselious Dental College |
| Address |
Room No 11
Department of periodontics,
Mar baselios dental college,
Thangalam.
Ernakulam
KERALA
686691
India |
| Phone |
8921303043 |
| Fax |
|
| Email |
drmajoa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Majo Ambooken |
| Designation |
Professor and Head of the Department |
| Affiliation |
Mar Baselios Dental College |
| Address |
Room no 11
Department of Periodontic
Mar Baselios dental college
Thangalam
Ernakulam
KERALA
686691
India |
| Phone |
8921303043 |
| Fax |
|
| Email |
drmajoa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 11
Department of periodontics
Mar basilos dental college
Thangalum, Kerala, 686691 |
|
|
Primary Sponsor
|
| Name |
Sherina Iqbal |
| Address |
Room no 11
Department of periodontics
Mar baselios dental college
Thangalam , Kothamangalam
Kerala 686691. |
| 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 |
| Dr Sherina Iqbal |
Mar baselios dental college |
Room no 11, Department of periodontics .
Ernakulam
KERALA |
9995042580
sherinaiqbal123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL REVIEW COMMITTEE,MAR BASELIOUS DENTAL COLLEGE |
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 |
Non-surgical intervention |
Single intervention-AMD Picasso diode Laser, wavelength- 810nm, power of 1.4 W,20ms interval,20ms duration
Control group-Ultrasonic scaling |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Stage 2 periodontitis patients with minimum of two sites have a probing pocket depth of 5mm in stleast two quadrants
Type 2 diabetic patients for aleast 2 year
Presence of st least 20 teeth in the mouth
Non smokers |
|
| ExclusionCriteria |
| Details |
Systemic disease that could affect periodontal treatment outcomes other than type 2 diabetic
History of major diabetic complication
History of any treatment for periodontal disease in the past 6 months
Use of any antibiotic or anti inflammatory drugs in the last 6 months
Pregnant or breastfeeding individuals |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of red complex bacteria and periodontal parameters in the management of stage 2 periodontitis in type 2 diabetics patients |
Baseline , 2 weeks , After 3Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Estimation of probing pocket depth,clinical attachment level ,gingival index,plaque index
Estimation of microbial load in periodontal pocket
Compare the effectiveness of SRP alone and SRP with adjunct diode laser |
Baseline ,2 week, after 3months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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 2 |
|
Date of First Enrollment (India)
|
22/07/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
It will be a split mouth longitudinal clinical study involving subjects with periodontal pocket depth 5-6 mm atleat two teeth.Subjects will receive full mouth ultrasonic supragingival scaling at first visit .The clinical parameters ,gingival index, plaque index ,probing pocket depth and clinical attachment level will be assessed at baseline ,2 weeks and 3 months. The sample collection for microbiological analysis will be done at 2 weeks and 3 months..After 2 weeks of recall ,plaque sample collection and reassessment of the clinical parameters will be done . A full mouth subgingival scaling followed by diode laser application on the test site ll be done in the same visit. The patient is recalled at the end of 3 months the clinical parameters are reassessed and plaque samples are again collected for microbiological analysis. The red complex bacterial count will be estimated for both study group using RT-PCR. |