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CTRI Number  CTRI/2024/03/064188 [Registered on: 15/03/2024] Trial Registered Prospectively
Last Modified On: 18/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Use of an air polishing powder along with ultrasonic tooth cleaning for treatment of gum disease.  
Scientific Title of Study   Evaluation Of Scaling And Root Planing With Or Without Glycine Powder Air Polishing In The Improvement Of Periodontal Parameters Among Patients With Mild To Moderate Periodontitis – A Split Mouth 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  Dr. Vuyyala Pani Pranavi 
Designation  Post Graduate Student 
Affiliation  Dayananda Sagar College Of Dental Sciences 
Address  Room 402, Department of Periodontology, Dayananda Sagar College of Dental Sciences, Shavige Malleshwara Hills, Kumaraswamy Layout, Bangalore

Bangalore
KARNATAKA
560078
India 
Phone  7259910753  
Fax    
Email  pranavi1996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Archana R Naik 
Designation  Reader 
Affiliation  Dayananda Sagar College Of Dental Sciences 
Address  Room 402, Department of Periodontology, Dayananda Sagar College of Dental Sciences, Shavige Malleshwara Hills, Kumaraswamy Layout, Bangalore

Bangalore
KARNATAKA
560078
India 
Phone  9986204322  
Fax    
Email  archananaik@dscds.edu.in  
 
Details of Contact Person
Public Query  
Name  Vuyyala Pani Pranavi 
Designation  Post Graduate Student 
Affiliation  Dayananda Sagar College Of Dental Sciences 
Address  Room 402, Department of Periodontology, Dayananda Sagar College of Dental Sciences, Shavige Malleshwara Hills, Kumaraswamy Layout, Bangalore

Bangalore
KARNATAKA
560078
India 
Phone  7259910753  
Fax    
Email  pranavi1996@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
Infrastructure support provided by Dayananda Sagar College of Dental Sciences, Bangalore. 
 
Primary Sponsor
Modification(s)  
Name  Dr Vuyyala Pani Pranavi 
Address  Room No. 402, Department of Periodontics, Dayananda Sagar College of Dental Sciences, Kumaraswamy layout, Bangalore. 
Type of Sponsor  Other [Self] 
 
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 Vuyyala Pani Pranavi  Dayananda Sagar College of Dental Sciences  Room 402, Department of Periodontology,Shavige Malleshwara Hills, Kumaraswamy Layout, Bangalore
Bangalore
KARNATAKA 		 7259910753

pranavi1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Dayananda Sagar College of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Glycine Powder Air Polishing  Intervetion will be applied only once after Scaling and Root Planing and assessments will be made at baseline and at the end of 1 month. 
Comparator Agent  Scaling and Root Planing (SRP)  Scaling and Root Planing will be done only once and assessments will be made at baseline and at the end of 1 month. 
 
Inclusion Criteria  
Age From  28.00 Year(s)
Age To  68.00 Year(s)
Gender  Both 
Details  1. Patients between 28–68 years of age (male and female).
2. Minimum of 3 teeth in each quadrant that had not received periodontal debridement
in last 3 months.
3. Pocket depth of 4 to 6mm on at least 2 or 3 teeth adjacent to each other on both sides either in the maxilla or mandible excluding the third molars. 
 
ExclusionCriteria 
Details  1.Patients with acute infectious oral lesions.
2.Patients who have furcation defects.
3.Patients using antibiotics within in last 4 weeks.
4.Patients who are pregnant and lactating mothers. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of
scaling and root planing (SRP) along with glycine powder air polishing (GPAP) and scaling
and root planing (SRP) alone in the improvement of periodontal parameters among patients with mild to moderate periodontitis.  		 At Baseline & at 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
plaque index (Silness J and Loe H
1964), gingival index (Loe H and Silness J 1963), probing pocket depth, clinical
attachment level, bleeding on probing (Gingival Bleeding Index Ainamo and Bay,
1975) 		 At Baseline & at 1 month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   31/03/2024 
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="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pranavi1996@gmail.com].

  6. For how long will this data be available start date provided 05-12-2024 and end date provided 05-03-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The prevalence of periodontitis is present worldwide. Periodontitis is an inflammatory disease of the gums and underlying bone, supporting the teeth. Scaling and root planing (deep cleaning) is required to eliminate or control the disease progression. However, SRP might not be able to provide complete debridement in all periodontal pockets. In an attempt to provide complete debridement in patients receiving SRP, glycine powder air-polishing (GPAP) has been tried to maximize the effectiveness of biofilm removal.

To the best of our knowledge, there are not many studies done in India that evaluate the effects of  Glycine powder air- polishing (GPAP) along with scaling and root planing (SRP) for the improvement of periodontal parameters among patients with mild to moderate periodontitis. The GPAP technique has the potential to resolve the above said challenges & hence a useful tool for all clinicians. Hence the purpose of this randomized controlled study is to evaluate the efficacy of scaling and root planing (SRP) along with glycine powder air polishing (GPAP) and scaling and root planing (SRP) alone in the improvement of periodontal parameters among patients with mild to moderate periodontitis.  
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