| 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
|
|
|
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
|
|
|
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. |