| CTRI Number |
CTRI/2026/04/108708 [Registered on: 20/04/2026] Trial Registered Prospectively |
| Last Modified On: |
19/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Short Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF TWO DIFFERENT DRUGS FOR THE SUBGINGIVAL APPLICATION WITH SCALING AND ROOT PLANING IN PERIODONTITIS PATIENTS. |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF SUBGINGIVAL APPLICATION OF BLUE – M GEL AND CHITOSAN AS ADJUNCT TO SCALING AND ROOT PLANING IN PERIODONTITIS – 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 |
Ritika |
| Designation |
Undergraduate Student |
| Affiliation |
Inderprastha Dental College And Hospital |
| Address |
Second Floor, Room No. 2, Department of Periodontics, 46/1, Site-IV, Sahibabad Industrial Area, Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
8130112848 |
| Fax |
|
| Email |
ritikaaagautam@gmail.cpm |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddhanth Singh |
| Designation |
Senior Lecturer |
| Affiliation |
Inderprastha Dental College And Hospital |
| Address |
Second Floor, Room No. 2, Department of Periodontics, 46/1, Site-IV, Sahibabad Industrial Area, Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
8130112848 |
| Fax |
|
| Email |
siidhanths9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siddhanth Singh |
| Designation |
Senior Lecturer |
| Affiliation |
Inderprastha Dental College And Hospital |
| Address |
Second Floor, Room No. 2, Department of Periodontics, 46/1, Site-IV, Sahibabad Industrial Area, Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
8130112848 |
| Fax |
|
| Email |
siddhanths9@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Inderprastha Dental College And Hospital |
| Address |
46/1,Site-IV,Industrial Area, Sahibabad, Ghaziabad-201010 (U.P.) |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Siddhanth Singh |
Inderprastha Dental College And Hospital |
Second Floor, Room No.2, Department of Periodontics, 46, Site-IV, Industrial Area, Sahibabad, Ghaziabad-201010 (U.P.)
Ghaziabad
UTTAR PRADESH |
8130112848
siidhanths9@gmail.cpm |
|
|
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 |
| Healthy Human Volunteers |
Meet the Inclusion Criteria |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Age Group:
Participants must be between 20 to 50 years (inclusive)
2. Periodontal Condition:
Patients should have periodontal pocket depth of 4–6 mm
Indicates mild to moderate periodontitis (Stage I / Stage II)
3. Gender:
Both males and females are included
4. Systemic Health:
Participants must be systemically healthy
No underlying systemic diseases affecting periodontal health
5. Medication Status:
Should not be on long-term medication
|
|
| ExclusionCriteria |
| Details |
1. Systemic Diseases:
Patients with any known systemic conditions such as:
Diabetes
Hypertension
Thyroid disorders
Or any disease that can affect periodontal health
These conditions can alter healing and influence study outcomes
2. Recent Periodontal Therapy:
Patients who have undergone any periodontal treatment in the last 6 months
This ensures baseline conditions are not altered by recent therapy
3. Tobacco Use:
Patients with habits like:
Smoking
Tobacco chewing
Tobacco affects periodontal healing and disease progression
4. Pregnancy & Lactation:
Pregnant and breastfeeding women are excluded
Due to hormonal influences and ethical considerations
5. Recent Antibiotic Use:
Patients who have taken antibiotics in the past 3 months
As antibiotics may alter oral microbial flora and bias results |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
PPD (Probing Pocket Depth) is the most important clinical indicator of periodontal disease severity.
• A reduction in PPD reflects:
• Improvement in periodontal health
• Effectiveness of Scaling and Root Planing (SRP)
• Additional benefit of Blue-M gel and Chitosan gel |
This is assessed at:
• Baseline (Day 0)
• Day 14
• Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/04/2026 |
| 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="1"
Months="0"
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 - NO
|
|
Brief Summary
|
This study is a randomized controlled trial conducted to evaluate and compare the effectiveness of Blue-M gel and chitosan gel (1%) as adjuncts to scaling and root planing (SRP) in patients with periodontitis.
A total of 51 systemically healthy patients aged 20–50 years with periodontal pocket depth of 4–6 mm are included and randomly divided into three groups: • Group 1: SRP alone (control) • Group 2: SRP + Blue-M gel • Group 3: SRP + Chitosan gel
Clinical parameters such as probing pocket depth (PPD), clinical attachment level (CAL), gingival index (GI), gingival bleeding index, and OHI-S are recorded at baseline (Day 0), Day 14, and Day 28.
The primary aim is to assess the reduction in probing pocket depth and compare the clinical effectiveness of both adjunctive gels in improving periodontal health.
The study is expected to provide insights into minimally invasive, effective adjunct therapies that enhance healing and reduce inflammation in periodontitis patients |