| CTRI Number |
CTRI/2024/07/070460 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing saliva tests in gum disease patients treated with laser and deep cleaning. |
|
Scientific Title of Study
|
Comparative evaluation of salivary biomarkers in stage II periodontitis patients using diode laser as an adjunct to scaling and root planing. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dona George |
| Designation |
Postgraduate resident |
| Affiliation |
Mar Baselios Dental College |
| Address |
Room no 11
Department Of Periodontics and Oral Implantology
Mar Baselios Dental College
Thangalam, Kothamangalam
Ernakulam
KERALA
686691
India |
| Phone |
8891110475 |
| Fax |
|
| Email |
donageorge1992.dg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Majo Ambooken |
| Designation |
Professor and Head Of The Department |
| Affiliation |
Mar Baselios Dental College |
| Address |
Room no 11
Department Of Periodontics and Oral Implantology
Mar Baselios Dental College
Thangalam, Kothamangalam
Ernakulam
KERALA
686691
India |
| Phone |
9447268750 |
| 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 Periodontics and Oral Implantology
Mar Baselios Dental College
Thangalam, Kothamangalam
Ernakulam
KERALA
686691
India |
| Phone |
9447268750 |
| Fax |
|
| Email |
drmajoa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Periodontics and Oral Implantology
Room no 11
Mar Baselios Dental College
Thankalam
Kothamangalam
Ernakulam
Pincode 686691
|
|
|
Primary Sponsor
|
| Name |
Dona George |
| Address |
Post Graduate Resident
Room No 11
Department Of Periodontics and Oral Implantology
Mar Baselios Dental College
Thangalam
Kothamangalam,Ernakulam,India
Pin-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 Dona George |
Mar Baselios Dental College |
Department Of Periodontics
Room no 11
Ernakulam
KERALA |
8891110475
donageorge1992.dg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee ,Mar Baselios Dental College,Thangalam ,Kothamangalam Review 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 |
| Comparator Agent |
Scaling and root planing |
Control group- scaling and root planing.
Test group-Scaling and root planing with diode laser will be done in the first week. Single-time intervention following in 3 months.
|
| Intervention |
Scaling and root planing with diode laser |
A diode laser (AMD PICASSO LASER) at 810 nm wavelength using a power of 1.4W, 20 ms interval, 20 ms duration will be applied after the first week.
Scaling and root planing by ultrasonic scaler and hand instruments will be done.
Single-time intervention following in 3 months.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18 and 60 years
Stage 11 periodontitis patients with at least two teeth in each quadrant having PPD greater than or equal to 5 mm |
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases
Tobacco smokers, alcohol or drug-dependent subjects
Patients who had received periodontal treatment or antibiotics in the past 6 months
Pregnant or lactating women
Persons with immune deficiency |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Laser therapy could enhance scaling and root planning outcomes in stage II periodontitis, and salivary analysis may serve as a non-invasive tool for evaluating treatment success. |
Baseline, first week,at 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| secondary outcome included improvements in clinical parameters such as reduced pocket depths ,gingival inflammation,and enhanced patient reported outcomes,highlighting the multifaceted benefits of laser therapy in managing periodontal diseases |
baseline,one week,third month |
|
|
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 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 comparative longitudinal study conducted among the subjects selected from the outpatient department of periodontics and oral implantology, Mar Baselios Dental College, Kothamangalam. The involved subjects had periodontal pocket depth greater than or equal to 5 mm in at least two teeth in each quadrant. Subjects for the study will be selected based on inclusion and exclusion criteria and a full mouth periodontal examination will be conducted .oral prophylaxis will be performed in all patients and divided randomly into two groups. Group A (the control group ) receives supra gingival scaling and Group B receives scaling root planing and laser therapy. The clinical parameters namely plaque index(PI), Gingival Index(GI ) , Probing Pocket Depth (PPD) and Clinical attachment levels (CAL ) will be assessed at baseline, one week before SRP and 3 months post treatments. The salivary samples will be collected and assessed at baseline, and 3 months post-treatment. The allocation of patients for specific interventions will be assigned by the guide. Diode laser ( AMD Picasso Laser ) at 810 nm wavelength using a power of 1.4 W,20 ms interval,20ms duration will be used in the test group. PROGNOSEEZ PLUS - A Multiplex Real-time PCR kit will be used for the detection of salivary biomarkers. DNA quantification by RT-PCR analysis of salivary biomarkers will be done at Shankaranarayana Life Sciences LLP, Bangalore |