| CTRI Number |
CTRI/2025/07/090841 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
compare the effect of Chlorhexidine Gel, Hyaluronan Gel And Blue-M Gel(R)in the treatment Of Chronic Periodontitis |
|
Scientific Title of Study
|
Comparative Evaluation of Effectiveness Of Chlorhexidine Gel, Hyaluronan Gel And Blue-M Gel(R), as an adjunct in the treatment Of Chronic 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 |
DR HAGE YAKANG |
| Designation |
Post Graduate Student |
| Affiliation |
GOVT DENTAL COLLEGE AND HOSPITAL NAGPUR, MAHARASHTRA |
| Address |
202, 2ND FLOOR DEPARTMENT OF PERIODONTOLOGY, GOVT DENTAL COLLEGE AND HOSPITAL NAGPUR, MAHARASHTRA
202, 2ND FLOOR DEPARTMENT OF PERIODONTOLOGY, GOVT DENTAL COLLEGE AND HOSPITAL NAGPUR, MAHARASHTRA
Nagpur
MAHARASHTRA
440003
India |
| Phone |
08413060310 |
| Fax |
|
| Email |
hageyakang97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaibhav karemore |
| Designation |
Associate Professor |
| Affiliation |
GOVT DENTAL COLLEGE AND HOSPITAL NAGPUR, MAHARASHTRA |
| Address |
202, 2ND FLOOR DEPARTMENT OF PERIODONTOLOGY, GOVT DENTAL COLLEGE AND HOSPITAL NAGPUR, MAHARASHTRA.
202, 2ND FLOOR DEPARTMENT OF PERIODONTOLOGY, GOVT DENTAL COLLEGE AND HOSPITAL NAGPUR, MAHARASHTRA.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
08413060310 |
| Fax |
|
| Email |
periodon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR HAGE YAKANG |
| Designation |
Post Graduate Student |
| Affiliation |
GOVT DENTAL COLLEGE AND HOSPITAL NAGPUR, MAHARASHTRA |
| Address |
202, 2ND FLOOR DEPARTMENT OF PERIODONTOLOGY, GOVT DENTAL COLLEGE AND HOSPITAL NAGPUR, MAHARASHTRA.
202, 2ND FLOOR DEPARTMENT OF PERIODONTOLOGY, GOVT DENTAL COLLEGE AND HOSPITAL NAGPUR, MAHARASHTRA.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
08413060310 |
| Fax |
|
| Email |
hageyakang97@gmail.com |
|
|
Source of Monetary or Material Support
|
| 202, 2nd floor, Department of Periodontology, GOVT DENTAL COLLEGE AND HOSPITAL NAGPUR, MAHARASHTRA |
|
|
Primary Sponsor
|
| Name |
Dr Yakang Hage |
| Address |
202, 2nd Floor, Department of Periodontology, GOVT DENTAL COLLEGE AND HOSPITAL NAGPUR, MAHARASHTRA |
| Type of Sponsor |
Other [Self- funded] |
|
|
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 HAGE YAKANG |
Government Dental College And Hospital Nagpur |
202, 2ND FLOOR DEPARTMENT OF PERIODONTOLOGY, GOVT DENTAL COLLEGE AND HOSPITAL NAGPUR, MAHARASHTRA
Nagpur
MAHARASHTRA |
08413060310
hageyakang97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College and Hospital |
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 |
| Comparator Agent |
Compare The Effectiveness Of Blue-M Gel(R) , as an adjunct in the treatment Of Chronic Periodontitis. |
All patients will be educated and motivated with emphasis on appropriate oral hygiene. Detailed history and assessment periodontal parameters such as inflammation, PI, GI, PPD and CAL of the patient will be done. 15 Sites (control group) Patients will receive non-surgical periodontal therapy with Blue-M Gel(R) as an adjunct after scaling and root planing. |
| Intervention |
Compare The Effectiveness Of Chlorhexidine Gel, as an adjunct in the treatment Of Chronic Periodontitis. |
All patients will be educated and motivated with emphasis on appropriate oral hygiene.
Detailed history and assessment periodontal parameters such as inflammation, PI, GI, PPD and CAL of the patient will be done.
15 Sites (control group) Patients will receive non-surgical periodontal therapy with chlorhexidine gel as an adjunct after scaling and root Planing. |
| Comparator Agent |
Compare The Effectiveness Of Hyaluronan Gel , as an adjunct in the treatment Of Chronic Periodontitis. |
All patients will be educated and motivated with emphasis on appropriate oral hygiene. Detailed history and assessment periodontal parameters such as inflammation, PI, GI, PPD and CAL of the patient will be done. 15 Sites (control group) Patients will receive non-surgical periodontal therapy with Hyaluronan Gel as an adjunct after scaling and root planing. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 )Age between 25 -60 years.
2 )Systemically healthy patients with presence of bleeding on probing.
3 )Subjects with Stage II Grade A periodontitis having PPD 5mm or less than 5mm at atleast 4 site.
4 )Subjects who didn’t receive any periodontal treatment for past 6 months.
|
|
| ExclusionCriteria |
| Details |
1)Patients with any systemic condition or immunocompromised.
2)Smoking, pregnancy, lactation.
3)Known hypersensitivity to one of the ingredients of hyaluronan gel preparation and oxygen releasing formula.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evalvate and compare the effect of Chlorhexidine Gel, Hyaluronan Gel And Blue-M Gel(R),as an adjunct in the treatment Of Chronic Periodontitis |
to evalvate and compare the effect of Chlorhexidine Gel, Hyaluronan Gel And Blue-M Gel(R),as an adjunct in the treatment Of Chronic Periodontitis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evalvate and compare the effect of Chlorhexidine Gel, Hyaluronan Gel And Blue-M |
to evalvate and compare the effect of Chlorhexidine Gel, Hyaluronan Gel And Blue-M |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="6"
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 randomized controlled trial evaluated the effectiveness of Chlorhexidine gel, Hyaluronan gel, and Blue-M® gel as adjuncts to scaling and root planing (SRP) in the treatment of chronic periodontitis. Clinical parameters including Plaque Index, Gingival Index, Probing Pocket Depth, and Clinical Attachment Level were assessed at baseline and follow-up. All three groups showed significant clinical improvement, but Blue-M® gel demonstrated superior outcomes in reducing inflammation and pocket depth, likely due to its oxygen-releasing and healing properties. Chlorhexidine was effective but caused some side effects, while Hyaluronan promoted healing. Blue-M® gel proved to be the most effective adjunctive agent overall |