| CTRI Number |
CTRI/2024/10/075983 [Registered on: 28/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Local application of synthetically manufactured gel for gum disease |
|
Scientific Title of Study
|
Evaluation of locally delivered alpha 2 macroglobulin for the management of periodontitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poulami Chakraborty |
| Designation |
Post graduate student |
| Affiliation |
Saveetha dental college and hospital |
| Address |
Saveetha dental college and hospital, Clinic 25, department of periodontics, Saveetha dental college and hospital, 162, Poonamallee High Road, Velappanchavadi, Chennai, Tamil Nadu, 600077
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9863566324 |
| Fax |
|
| Email |
152205004.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ND Jayakumar |
| Designation |
Professor and Dean of faculty |
| Affiliation |
Saveetha dental college and hospital |
| Address |
Saveetha dental college and hospital, Clinic 25, department of periodontics, Saveetha dental college and hospital, 162, Poonamallee High Road, Velappanchavadi, Chennai, Tamil Nadu, 600077
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9444071930 |
| Fax |
|
| Email |
Jayakumarnd@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
ND Jayakumar |
| Designation |
Professor and Dean of faculty |
| Affiliation |
Saveetha dental college and hospital |
| Address |
Saveetha dental college and hospital, Clinic 25, department of periodontics, Saveetha dental college and hospital, 162, Poonamallee High Road, Velappanchavadi, Chennai, Tamil Nadu, 600077
TAMIL NADU
600077
India |
| Phone |
9444071930 |
| Fax |
|
| Email |
Jayakumarnd@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals 162, Poonamallee High Road, velappanchavadi, Chennai, Tamilnadu, India. PIN - 600077 |
|
|
Primary Sponsor
|
| Name |
Poulami Chakraborty |
| Address |
Clinic 25, Department of Periodontics, Saveetha Dental College and Hospitals, 162 Poonamallee High Road,Velappanchavadi, Chennai, Tamilnadu, India |
| Type of Sponsor |
Other [Self funding ] |
|
|
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 Poulami Chakraborty |
Saveetha dental college and hospital |
Room No. Clinic 25, Department of periodontics, Saveetha dental college and hospital
Thiruvallur
TAMIL NADU |
9863566324
152205004.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha dental college - Institutional Human 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 |
Alpha 2 macroglobulin hydrogel as local drug delivery agent |
First patient to be treated with scaling and root planing followed by application of alpha 2 macroglobulin hydrogel as local drug delivery agent in periodontal pockets. This application is one time only and not repeated in this study period. To be evaluated after 30th day and 45 day. The total duration of study period is 45 days. |
| Comparator Agent |
Control group |
Patient to be treated with scaling and root planing. To be evaluated at 30th day and 45 day following treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with atleast 1 site probing depth more than 4mm
2. Patient requiring non surgical treatment were eligible for the study |
|
| ExclusionCriteria |
| Details |
Patients with habits like-smoking, tobacco chewing, having uncontrolled diabetes, hypertension or immunocompromised conditions, pregnant women or lactating mothers, noncompliant or physically challenged people. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical attachment loss and Pocket probing depth, Gingival Index, OHI |
Baseline, 30th day, 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MMP-9 gene expression |
Baseline, 45th day |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
19/11/2024 |
| Date of Study Completion (India) |
01/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/08/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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 disease is a multifactorial chronic inflammatory disease caused by a complex of bacteria interacting with host tissues and cells, which ultimately leads to destruction of the periodontal structures
- Pathogens is involves colonization of periodontal-pathogenic bacteria subgingivally and host response of periodontopathogens which leads to increased production of inflammatory mediators and MMPs.
- Mechanical debridement is gold standard for eradicating periodontopathogens .
- Alpha 2 macroglobulins are large glycoproteins and an integral part of innate immunity. These belong to the family of antiproteases. Alpha -2 macroglobulin inhibits the excess of proteinases released during tissue injury and contributes in protecting body from wide disturbances. When there is imbalance between level of protease inhibitors and level of protease secretion in body it leads to rapid tissue destruction. Locally delivering protease inhibitors at the site of inflammation may enhance pro-resolving responses.
- The aim of this study is to incorporate A2M into hydrogel and apply it as local drug delivery agent in periodontitis management
|