| 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
|
|
|
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
|
|
|
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. |