| CTRI Number |
CTRI/2025/09/095081 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing Two Types of Chitosan Gels for Treating Gum Pockets and Their Impact on Saliva Enzyme Levels in Men and Women |
|
Scientific Title of Study
|
Comparing Thermosensitive and Non-Thermosensitive Chitosan gels in treating periodontal pockets and their effect on Salivary Pyruvate kinase levels in age matched men and women: a split-mouth clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jammula Surya Prasanna |
| Designation |
Senior Professor |
| Affiliation |
Panineeya Mahavidyala Institute of Dental Sciences and Research Centre |
| Address |
Room No. 101, Department of Periodontics, Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre, Road No. 5, Kamalanagar, Dilsukhnagar, Hyderabad.
Hyderabad
TELANGANA
500060
India |
| Phone |
9440387830 |
| Fax |
|
| Email |
surya.prasanna@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jammuna Surya Prasanna |
| Designation |
Senior Professor |
| Affiliation |
Panineeya Mahavidyala Institute of Dental Sciences and Research Centre |
| Address |
Room No. 101, Department of Periodontics, Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre, Road No. 5, Kamalanagar, Dilsukhnagar, Hyderabad.
Hyderabad
TELANGANA
500060
India |
| Phone |
9440387830 |
| Fax |
|
| Email |
surya.prasanna@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Vinnakota Aparna |
| Designation |
post graduate |
| Affiliation |
Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre |
| Address |
Room No. 101, Department of Periodontics, Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre, Road No. 5, Kamalanagar, Dilsukhnagar, Hyderabad.
Hyderabad
TELANGANA
500060
India |
| Phone |
7330927014 |
| Fax |
|
| Email |
aparnavinnakota30@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Panineeya Mahavidyalaya Institute of Dental Sciences and Research centrer |
| Address |
road no 5 kamalanagar Dilsukhnagar , Hyderabad,500060,Telangana,India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vinnakota Aparna |
Panineeya Mahavidyalaya Institute of Dental Sciences and Research centre |
Room No. 101, Department of Periodontics, Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre, Road No. 5, Kamalanagar,Dilsukhnagar,500060, Hyderabad.
Hyderabad
TELANGANA |
07330927014
aparnavinnakota30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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 |
| Comparator Agent |
group 1 Scaling and Root Planing with chitosan gel with thermosensitive property |
18 subjects (males and females) treated with scaling and root planing with chitosan thermosensitive gel.
At baseline, saliva samples are collected from all participants for the estimation of pyruvate kinase enzyme (using ELISA) and a baseline assessment of clinical periodontal parameters is performed: bleeding on probing (BOP), Russell’s periodontal index (RPI), probing pocket depth (PPD), and clinical attachment level (CAL).
After treatment, the same clinical periodontal parameters (BOP, RPI, PPD, CAL) are assessed at 1, 3, and 6 months.
Additionally, salivary samples for pyruvate kinase estimation are collected again after 1 month.
|
| Comparator Agent |
group 2 Scaling and Root Planing with chitosan gel without thermosensitive property |
18 subjects (males and females) treated with scaling and root planing,chitosan gel lacking thermosensitive properties.
At baseline, saliva samples are collected from all participants for the estimation of pyruvate kinase enzyme (using ELISA) and a baseline assessment of clinical periodontal parameters is performed: bleeding on probing (BOP), Russell’s periodontal index (RPI), probing pocket depth (PPD), and clinical attachment level (CAL).
After treatment, the same clinical periodontal parameters (BOP, RPI, PPD, CAL) are assessed at 1, 3, and 6 months.
Additionally, salivary samples for pyruvate kinase estimation are collected again after 1 month.
|
| Intervention |
group 3 SCALING AND ROOT PLANING |
10 subjects (males and females) treated with scaling and root planing and receive no gel.
At baseline, saliva samples are collected from all participants for the estimation of pyruvate kinase enzyme (using ELISA) and a baseline assessment of clinical periodontal parameters is performed: bleeding on probing (BOP), Russell’s periodontal index (RPI), probing pocket depth (PPD), and clinical attachment level (CAL).
After treatment, the same clinical periodontal parameters (BOP, RPI, PPD, CAL) are assessed at 1, 3, and 6 months.
Additionally, salivary samples for pyruvate kinase estimation are collected again after 1 month.
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy.
Patients who have not received periodontal therapy within 6 months.
Periodontal pockets with 4-7mm.
No antimicrobials for 1 month prior to the study.
|
|
| ExclusionCriteria |
| Details |
Presence of other systemic disorder, genetic disorders, and diseases which will Affect periodontal health.
Patients with Acute oral disease.
Smokers and tobacco chewers and alcoholics
Patient who are allergic to drugs.
Pregnant and lactating women.
Patients who do not comply to oral hygiene instructions and recall maintenance.
Patients who are medically and mentally challenged |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. What is the comparative performance of chitosan gels with thermosensitive properties versus those without them in managing periodontal pockets?
2.How do chitosan gels impact the levels of pyruvate kinase (PK) enzyme in saliva? |
BASELINE TO 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
How effective are chitosan gels on clinical parameters of moderate to severe periodontitis ?
|
BASELINE TO 6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
09/03/2026 |
| 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="6"
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
|
Periodontitis is influenced by the accumulation of dysbiotic subgingival biofilm, which amplifies the immune response. Various enzymes produced by the body contribute to periodontal diseases and can be utilized to monitor disease progression and assess the effectiveness of periodontal therapy. These enzymes reflect metabolic changes in the gingiva and periodontium, making them useful for diagnosing disease activity. As these enzymes are secreted into bodily fluids like saliva and gingival crevicular fluid (GCF), these fluids can serve as diagnostic mediators. pyruvate kinase (PK) being one of the enzymes identified in periodontal disease. PK plays a significant role in the development of periodontitis due to the increased metabolic demands of immune cells. It also modulates the production of pro-inflammatory cytokines, thereby influencing the progression of periodontal disease. Antimicrobial polymers, particularly chitosan, emerge as potential treatments for oral diseases. Chitosan has various biological properties, including antibacterial, anti-inflammatory, and regenerative effects. This drug is available in various forms for local drug deliveries. Thermosensitive chitosan hydrogels, which transition from liquid to gel at body temperature, are being explored for controlled drug delivery and periodontal therapy. This study aims to evaluate different chitosan formulations for their effectiveness in treating periodontitis and their impact on pyruvate kinase levels. |