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CTRI Number  CTRI/2026/03/106311 [Registered on: 16/03/2026] Trial Registered Prospectively
Last Modified On: 16/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing plaque index, patient Comfort and Dentist Choice between Guided Biofilm Therapy and Ultrasonic Piezo Scaling 
Scientific Title of Study   Comparison of Patient Perceptions and Practitioner Preferences in Guided Biofilm Therapy Versus Ultrasonic Piezo Scaling: 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  Dr Kata Sai Sruthi 
Designation  Postgraduate 
Affiliation  GSL DENTAL COLLEGE AND HOSPITAL 
Address  ROOM NO 10, DEPARTMENT OF PERIODONTICS, GSL DENTAL COLLEGE & HOSPITAL NH-16 LAKSHMIPURAM RAJAHMUNDRY 533296 ANDHRAPRADESH INDIA

East Godavari
ANDHRA PRADESH
533296
India 
Phone  6304476298  
Fax    
Email  sruthikata@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anupama Masapu 
Designation  professor and head of the department 
Affiliation  GSL DENTAL COLLEGE AND HOSPITAL 
Address  ROOM NO 10, DEPARTMENT OF PERIODONTICS, GSL DENTAL COLLEGE & HOSPITAL, NH-16, LAKSHMIPURAM RAJAHMUNDRY, 533296, ANDHRAPRADESH, INDIA.

East Godavari
ANDHRA PRADESH
533296
India 
Phone  9985313267  
Fax    
Email  anu3267@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kata Sai Sruthi 
Designation  postgraduate 
Affiliation  GSL DENTAL COLLEGE AND HOSPITAL 
Address  ROOM NO 10, DEPARTMENT OF PERIODONTICS, GSL DENTAL COLLEGE & HOSPITAL NH-16 LAKSHMIPURAM RAJAHMUNDRY 533296 ANDHRAPRADESH INDIA

East Godavari
ANDHRA PRADESH
533296
India 
Phone  6304476298  
Fax    
Email  sruthikata@gmail.com  
 
Source of Monetary or Material Support  
ROOM NO 10, DEPARTMENT OF PERIODONTICS, GSL DENTAL COLLEGE & HOSPITAL NH-16 LAKSHMIPURAM RAJAHMUNDRY 533296 ANDHRAPRADESH INDIA 
 
Primary Sponsor  
Name  GSL DENTAL COLLEGE AND HOSPITAL 
Address  ROOM NO 10, DEPARTMENT OF PERIODONTICS, GSL DENTAL COLLEGE & HOSPITAL NH-16 LAKSHMIPURAM RAJAHMUNDRY 533296 ANDHRAPRADESH INDIA 
Type of Sponsor  Other [PRIVATE DENTAL COLLEGE] 
 
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 Kata Sai Sruthi  GSL DENTAL COLLEGE AND HOSPITAL  ROOM NO 10, DEPARTMENT OF PERIODONTICS, GSL DENTAL COLLEGE & HOSPITAL NH-16 LAKSHMIPURAM RAJAHMUNDRY 533296 ANDHRAPRADESH INDIA
East Godavari
ANDHRA PRADESH 
6304476298

sruthikata@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GSL DENTAL COLLEGE AND HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K050||Acute gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  guided biofilm therapy  Subgingival and supragingival biofilm removal using air polishing and guided biofilm therapy protocol to evaluate plaque index and patient perception at baseline 
Comparator Agent  ultrasonic piezo scaling  Conventional supragingival and subgingival scaling performed using an ultrasonic piezoelectric scaler to compare plaque index reduction and patient perception at baseline 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Participants eligible for the study were adults aged 18 to 60 years with a minimum of 20 natural teeth. The teeth included in the study were required to be free from dental caries, abrasion, erosion, or any other structural defects. Only systemically healthy individuals diagnosed with Stage I or Stage II periodontitis were included. Additionally, participants were required to have no caries or abrasions present in the teeth selected for evaluation 
 
ExclusionCriteria 
Details  The exclusion criteria included individuals with systemic diseases such as diabetes, heart disease, or cancer, and those suffering from respiratory diseases including chronic obstructive pulmonary disease or asthma. Participants who had used antibiotics within three months prior to the start of the study were also excluded. In addition, pregnant or lactating women, individuals with a known allergy to chlorhexidine or erythritol, and smokers consuming more than 10 cigarettes per day were not eligible for inclusion. Furthermore, individuals who were unwilling to undergo the proposed treatment were excluded from the study 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Plaque index and questionnaires assessing comfort, pain, sensitivity, efficiency, and satisfaction levels ranges from 0-10 after treatment  BASELINE 
 
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)   01/05/2026 
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="30" 
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  
Periodontal diseases, primarily caused by microbial biofilm, remain one of the most prevalent oral health problems and a major reason for tooth loss in adults. Although conventional scaling and root planing (SRP) with hand and ultrasonic instruments has long been considered the gold standard for biofilm removal, it is often time-consuming. technique-sensitive, and associated with adverse effects such as cementum loss. postoperative sensitivity, and considerable patient discomfort. These limitations highlight the need for less invasive, more efficient, and patient-friendly alternatives. Guided Biofilm Therapy (GBT), which integrates air-polishing with ultrasonic instrumentation, offers a systematic and minimally invasive approach that may reduce treatment time, enhance patient comfort, and improve clinical efficiency while maintaining therapeutic effectiveness. Therefore, it is necessary to evaluate and compare GBT with conventional scaling to determine its clinical relevance, patient acceptance, and practitioner preference.
 
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