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CTRI Number  CTRI/2025/10/096083 [Registered on: 15/10/2025] Trial Registered Prospectively
Last Modified On: 14/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Guided Biofilm Therapy Using Erythritol vs. Glycine: A Clinical Comparison 
Scientific Title of Study   Guided biofilm therapy- A pioneering approach utilizing piezo instrumentation using erythritol compared with glycine air polishing: A 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  Vemula Niharika  
Designation  Student 
Affiliation  LENORA INSTITUTE OF DENTAL SCIENCES  
Address  Department of Periodontics 2nd floor Lenora Institute of dental sciences Rajanagaram Rajahmundry 533294

East Godavari
ANDHRA PRADESH
533294
India 
Phone  8106103236  
Fax    
Email  niharikavemula20@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nandipati Sowmya Reddy  
Designation  Assistant Professor  
Affiliation  LENORA INSTITUTE OF DENTAL SCIENCES 
Address  Department of Periodontics 2nd floor Lenora Institute of dental sciences Rajanagaram Rajahmundry 533294

East Godavari
ANDHRA PRADESH
533294
India 
Phone  6381512793  
Fax    
Email  sowmyareddy848@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nandipati Sowmya Reddy  
Designation  ASSISTANT PROFESSOR 
Affiliation  LENORA INSTITUTE OF DENTAL SCIENCES 
Address  Department of Periodontics 2nd floor Lenora Institute of dental sciences Rajanagaram Rajahmundry 533294

East Godavari
ANDHRA PRADESH
533294
India 
Phone  6381512793  
Fax    
Email  sowmyareddy848@gmail.com  
 
Source of Monetary or Material Support  
Self funded (Lenora Institute of dental sciences) 
 
Primary Sponsor  
Name  Vemula Niharika  
Address  Department of periodontics 2nd floor Lenora institute of dental sciences Rajanagaram Rajahmundry 533294 Rajahmundry  
Type of Sponsor  Other [Self funded (Niharika Vemula)] 
 
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 Niharika Vemula   Lenora Institute of dental sciences   Department of Periodontics 2nd floor Lenora Institute of dental sciences Rajanagaram Rajahmundry 533294
East Godavari
ANDHRA PRADESH 
8106103236

niharikavemula20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  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  Erythritol  Topical application after scaling  
Comparator Agent  Glycine   Topical application after scaling  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  a. A minimum of 20 teeth
b. Diagnosed stage II, III grade A or B periodontitis

 
 
ExclusionCriteria 
Details  a. Systemic antibiotic therapy in the 3 months preceding the base line examination.
b. Anti- inflammatory medication, corticosteroids or other immune- suppressive drugs during the previous 6 months.
c. Heavy smokers, more than 10 cigarettes daily and/or presenting with dark brown stains along with cigar and pipe smoking.
d. Self- reported pregnancy or lactation.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Plaque index
Gingival index  
Baseline 1 month and 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   26/10/2025 
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="3"
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  

 The primary outcome is to evaluate the effectiveness of erythritol and glycine for biofilm removal by combining an air abrasive device with ultrasonic piezo instrumentation (Guided Biofilm Therapy) after initial scaling.

Thirty periodontal patients were randomly divided into two groups (n=15). Group A will be receiving erythritol-based air polishing, while Group B will be receiving glycine-based polishing. At baseline, all patients will be undergoing comprehensive periodontal examination, with Plaque Index (PI), Gingival Index (GI) will be recorded. A disclosing agent will be applied prior to treatment for targeted biofilm removal. Group A will be treated with an AIRFLOW® device using erythritol powder, and Group B with glycine powder, according to manufacturer’s protocol followed by supragingival and subgingival polishing will be performed by a single calibrated operator. Oral hygiene instructions will be given at each visit. Clinical parameters will be reassessed at 1 month and 3 months to evaluate the effectiveness of both powders in non-surgical periodontal therapy. This study hypothesizes that the gingival health condition of the patients of group A  will be superior to that of group B. 

 
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