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CTRI Number  CTRI/2024/08/072784 [Registered on: 20/08/2024] Trial Registered Prospectively
Last Modified On: 11/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing conventional Non Surgical Periodontal therapy with Minimally invasive Non Surgical Periodontal therapy 
Scientific Title of Study   Comparative analysis of conventional non-surgical periodontal therapy with minimally invasive Non Surgical periodontal therapy in patients with Periodontitis : A Split mouth single blind Randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dheeraj V 
Designation  Post Graduate Student 
Affiliation  Yenepoya Dental College 
Address  Room No 7, Department of Periodontology, Yenepoya Dental College, Yenepoya Deemed to be University, Deralakatte, Mangalore


KARNATAKA
575018
India 
Phone  9500761291  
Fax    
Email  dheeju20av@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Shashikanth Hegde 
Designation  Professor  
Affiliation  Yenepoya Dental College 
Address  Room No 7, Department of Periodontology, Yenepoya Dental College, Yenepoya Deemed to be University, Derelakatte, Mangalore


KARNATAKA
575018
India 
Phone  7846870977  
Fax    
Email  drshashikanthhegde@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dheeraj V 
Designation  Post Graduate Student 
Affiliation  Yenepoya Dental College 
Address  Room No 7, Department of Periodontology, Yenepoya Dental College, Yenepoya Deemed to be University, Deralakkatte, Mangalore

Salem
TAMIL NADU
575018
India 
Phone  9500761291  
Fax    
Email  dheeju20av@gmail.com  
 
Source of Monetary or Material Support  
Room no 7, Department of Periodontology, Yenepoya Dental College, Yenepoya Deemed to be University, Deralakatte, Mangalore- 575018 
 
Primary Sponsor  
Name  Dheeraj V 
Address  Room No 7, Department of Periodontology, 2nd Floor, Yenepoya Dental College, Yenepoya Deemed to be University, Deralakatte, Mangalore- 575018 
Type of Sponsor  Other [Self funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dheeraj V  Yenepoya Dental College  Room 7 2nd floor Department of Periodontology , Yenepoya Dental College ,Yenepoya Deemed to be University, Deralakatte, Mangalore, Dakshina Kannada KARANATAKA
Dakshina Kannada
KARNATAKA 		 9500761291

dheeju20av@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Periodontitis Stage II/III  
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Scaling and root planing   Conventional ultrasonic tips and conventional gracey curettes 
Intervention  Scaling and root planing with loupes  Minimally invasive ultrasonic tips (P1, P3), Mini five micro mini five and after five curettes 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Systemically healthy patients
2.Patients with severe/advanced periodontitis (i.e. stage II/III) with slow/moderate progression (i.e.grade A)
3. Age group: 25 to 60 years
4. Gender: males and females
5. Minimum of 20 Permanent teeth
6. Presence of at least two teeth with PD ≥5mm on both sides of either arches
 
 
ExclusionCriteria 
Details  1. Pregnant and lactating women
2. Tobacco smokers
3. History of periodontal treatment in the last 6 months
4. History of systemic antibiotics or anti-inflammatory medications in the last 6 months
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare and analyse conventional non surgical periodontal therapy with minimally invasive non surgical periodontal therapy   Baseline, 1 month , 3 month  
 
Secondary Outcome  
Outcome  TimePoints 
To compare and analyse conventional non surgical periodontal therapy with minimally invasive non surgical periodontal therapy  3 months 
 
Target Sample Size   Total Sample Size="19"
Sample Size from India="19" 
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 3 
Date of First Enrollment (India)   11/09/2024 
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="2"
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   Periodontitis, also known as gum disease is a serious infection that damages soft tissue  around the teeth. It is disease of the tissue surrounding the tooth structure. Periodontitis is caused by inflammation of the tissues that support the teeth. It can also lead to loss of the periodontal ligament attachment and bony support. The initial periodontal treatment aims to minimise supra/sub gingival plaque, calculus deposits and bacterial load through behavioural adjustments and risk factor management supported by non surgical debridement techniques like scaling and root planing in conventional method. In Minimally invasive non surgical periodontal therapy the use of ultrasonic devices with delicate tips, small curettes with longer terminal shanks and thinner blades, and use of magnification loupes is recommended to enable through subgingival debridement with minimal tissue trauma.   
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