| CTRI Number |
CTRI/2025/06/088153 [Registered on: 03/06/2025] Trial Registered Prospectively |
| Last Modified On: |
02/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate sclerostin levels which determine the severity of the disease in gum fluid in participants with gum disease by using local drug delivery agent called chitosan fiber followed by the comparison of the sclerostin levels before and after the treatment. |
|
Scientific Title of Study
|
Evaluation of Sclerostin Levels in Periodontitis Patients Treated with Chitosan Fiber as an Adjunct to Scaling and Root Planing: A Clinico-biochemical 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 |
Dr Poojitha Koppada |
| Designation |
Post Graduation Student |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
GITAM Dental College and Hospital
Department of periodontics
Room number 6
Gandhinagar Campus
Rushikonda
Visakhapatnam
GITAM Dental College and Hospital
Department of periodontics
Room number 6
Gandhinagar Campus
Rushikonda
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
8919797776 |
| Fax |
|
| Email |
pujithapooja95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P TANUJA |
| Designation |
Professor |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
GITAM Dental College and Hospital
Department of periodontics
Room number 6
Gandhinagar Campus
Rushikonda
Visakhapatnam
GITAM Dental College and Hospital
Department of periodontics
Room number 6
Gandhinagar Campus
Rushikonda
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9441313131 |
| Fax |
|
| Email |
drtanujap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poojitha Koppada |
| Designation |
Post Graduation Student |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
GITAM Dental College and Hospital
Department of periodontics
Room number 6
Gandhinagar Campus
Rushikonda
GITAM Dental College and Hospital
Department of periodontics
Room number 6
Gandhinagar Campus
Rushikonda
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
8919797776 |
| Fax |
|
| Email |
pujithapooja95@gmail.com |
|
|
Source of Monetary or Material Support
|
| GITAM Dental College and Hospital Department of periodontics
Gandhinagar Campus Rushikonda
Visakhapatnam Andhra Pradesh 530045 |
|
|
Primary Sponsor
|
| Name |
Dr Poojitha Koppada |
| Address |
Door no 2 22 8 by 4
MIG 111 by 2 SF 1 3rd floor
Khayyum residency
MVP colony sector 6
Pincode 530017
Visakhapatnam
Andhra pradesh |
| 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 Poojitha Koppada |
GITAM Dental College and Hospital |
Department of Periodontics
Room number 6
Gandhinagar Campus
Rushikonda
Pin 530045
Visakhapatnam
ANDHRA PRADESH |
8919797776
pujithapooja95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GITAM 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, (2) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Scaling and Root planing alone |
Evaluation and comparison of sclerostin levels in GCF and clinical parameters such as plaque index , probing pocket depth and clinical attachment loss at baseline and at 3 months post-operatively. |
| Intervention |
Scaling and Root Planing followed by placement of Chitosan Fiber |
Evaluation and comparison of sclerostin levels in GCF and clinical parameters such as plaque index , probing pocket depth and clinical attachment loss at baseline and at 3 months post-operatively. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with chronic periodontitis with pocket depth of more than or equal to 5mm
Selected teeth should be devoid of root demineralisation and or root caries
Systemically healthy subjects
Subjects with good compliance
|
|
| ExclusionCriteria |
| Details |
Subjects with systemic diseases and conditions
Subjects who underwent periodontal treatment within 6 months prior to the study
Smokers and Tobacco users
Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sclerostin levels in the gingival crevicular fluid
|
Sclerostin levels in the gingival crevicular fluid evaluation and comparison at 3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Plaque index
Probing pocket depth
Clinical attachment loss |
Plaque index evaluation and comparison at 3 months
Probing pocket depth evaluation and comparison at 3 months
Clinical attachment loss evaluation and comparison at 3 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
24/06/2025 |
| 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="1"
Months="0"
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 title of the study is Evaluation of Sclerostin
Levels in Periodontitis Patients Treated with Chitosan Fiber as an Adjunct to
Scaling and Root Planing A Clinico-biochemical Study. A total of 20 sites from 10 systemically healthy subjects satisfying the inclusion criteria and providing consent for study participation will be selected and split into two groups, test sites and control sites. The test sites will be receiving scaling and root planing followed by the placement of chitosan fiber subgingivally as a local drug delivery agent. The control sites will be receiving scaling and root planing alone. The sclerostin levels from the GCF samples will be assessed using ELISA kit prior to the procedure and after 3 months post operatively. These levels will be evaluated and compared in both the groups. Clinical parameters such as Plaque index , Probing pocket depth and Clinical attachment loss will also be evaluated and compared in both the groups pre operatively and after 3 months post operatively. |