| CTRI Number |
CTRI/2024/06/069459 [Registered on: 25/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Treatments for Gum Disease: Diode Laser with and without Herbal Oil Irimedadi Taila |
|
Scientific Title of Study
|
Comparison of the Efficacy of Diode Laser Assisted Scaling and Root Planing with and without Herbal Adjunct Irimedadi Taila in Chronic Periodontitis Patients A Split Mouth 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 |
Dr Shirley Joshini Samvel |
| Designation |
PG student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Periodontology , Sri Ramachandra Dental College and Hospital , Sri Ramachandra Institute of Higher Education and Research ,
Ramachandra Nagar , Porur , Chennai - 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9361890718 |
| Fax |
|
| Email |
shirleysamvel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Moses Ravindran |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Periodontology , Sri Ramachandra Dental College and Hospital , Sri Ramachandra Institute of Higher Education and Research ,
Ramachandra Nagar , Porur , Chennai - 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841311211 |
| Fax |
|
| Email |
deepak_perio@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shirley Joshini Samvel |
| Designation |
PG student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Periodontology , Sri Ramachandra Dental College and Hospital , Sri Ramachandra Institute of Higher Education and Research ,
Ramachandra Nagar , Porur , Chennai - 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9361890718 |
| Fax |
|
| Email |
shirleysamvel@gmail.com |
|
|
Source of Monetary or Material Support
|
|
( Sri Ramachandra Institute of Higher Education and Research, Ramachandra Nagar, Porur , Chennai-600116) |
|
|
Primary Sponsor
|
| Name |
Dr Shirley Joshini Samvel |
| Address |
Sri Ramachandra Dental College and Hospital ,
Sri Ramachandra Institute of Higher Education and Research
Porur, Chennai-600116.
|
| 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 Shirley Joshini Samvel |
Sri Ramachandra Dental College and Hospital |
Department of Periodontology Sri Ramachandra Dental College and Hospital ,
Sri Ramachandra Institute of Higher Education and Research
Porur, Chennai-600116.
Chennai
TAMIL NADU |
9361890718
shirleysamvel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Commitee for Student Project , SRIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K053||Chronic periodontitis. Ayurveda Condition: DANTAVAIDARBAH/DANTAVIDARBA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Diode laser assisted Scaling and root planing without application of the product | Teeth on the control side are treated with scaling and root planing followed by diode laser Curettage
Duration : 1 day | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Irimedadi Taila, Reference: Ayurveda Text : Chakradatta , Chapter 48 Shloka 21, Route: Topical, Dosage Form: Taila, Dose: 3(drops), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis : Generalised Chronic periodontits
Periodontal Probing Depth : 4mm or more
Minimum 20 teeth present with no visible untreated caries , BOP Present ,
No Oral Prophylactic procedure for past 6 months
|
|
| ExclusionCriteria |
| Details |
i. Patients on Antibiotic / any other drugs for past 3 months
ii. Pregnant Women / lactating Mothers
iii. Medically Compromised Patients
iv. Patients with Adverse habits such as tobacco / Alcohol consumption
v. Patients with Partial Dentures
vi. Patients with Overhanging Restorations / Bridges / Orthodontic Appliances
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Probing Pocket Depth , Plaque Index , Gingival Index , Modified Sulcular Bleeding Index , Periodontal Inflammed Surface Area |
Baseline , 4 weeks , 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in overall Gingival and Periodontal Health |
Baseline , 4 weeks , 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="8"
Sample Size from India="8"
Final Enrollment numbers achieved (Total)= "8"
Final Enrollment numbers achieved (India)="8" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
08/07/2024 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Subjects with periodontitis will be included in this single centre, single blinded, split-mouth, randomized clinical trial. Teeth on the control group will be treated with Diode Laser assisted SRP, while those on the contralateral test side will be treated using Irimedadi Taila as adjunct to Diode Laser assisted SRP. Clinical parameters such as probing pocket depth (PPD), PISA Index , Plaque Index and Gingival Index , Sulcular Bleeding index will be recorded at baseline 4 weeks and 8 wee following the initial instrumentation |