| CTRI Number |
CTRI/2025/08/092876 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effect of Deep Gum Cleaning on Natural Proteins Linked to Gum Health |
|
Scientific Title of Study
|
Effect of scaling and root planning
On the expression of
neuregulin-4
Levels and its receptor erbb4 in gcf in
Stage ii periodontitis patients with
And without type 2 diabetis mellitus.
|
| 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 Sai Pragathi |
| Designation |
Post graduate student |
| Affiliation |
Vydehi institute of dental sciences and research centre |
| Address |
Department of periodontics,room number6,
Vydehi institute of dental sciences and research centre, Bangalore
Bangalore
KARNATAKA
560066
India |
| Phone |
09606192641 |
| Fax |
|
| Email |
drsaipragathireddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Shruthi |
| Designation |
Reader |
| Affiliation |
Vydehi institute of dental sciences and research centre |
| Address |
Department of periodontics,room number 6,
Vydehi institute of dental sciences and research centre, Bangalore
Bangalore
KARNATAKA
560066
India |
| Phone |
9886824276 |
| Fax |
|
| Email |
shruthi_s1984@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sai Pragathi |
| Designation |
Post graduate student |
| Affiliation |
Vydehi institute of dental sciences and research centre |
| Address |
Department of periodontics,room number 6,
Vydehi institute of dental sciences and research centre, Bangalore
Bangalore
KARNATAKA
560066
India |
| Phone |
09606192641 |
| Fax |
|
| Email |
drsaipragathireddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of periodontics,room number6,
Vydehi institute of dental sciences and research centre, Bangalore,560066,Karnataka |
|
|
Primary Sponsor
|
| Name |
Sai pragathi |
| Address |
Department of periodontics,room number 6, second floor 82, Nallurahalli Main Rd, near BMTC 18th Depot, Vijayanagar, Nallurhalli, Whitefield, Bengaluru, Karnataka 560066 |
| Type of Sponsor |
Other [] |
|
|
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 |
| Sai Pragathi |
Vydehi institute of dental sciences and research center |
Department of periodontics,room number 6, second floor
82, Nallurahalli Main Rd, near BMTC 18th Depot, Vijayanagar, Nallurhalli, Whitefield, Bengaluru, Karnataka 560066
Bangalore
KARNATAKA |
9606192641
drsaipragathireddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| vydehi institute of dental sciences-institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Effect of scaling and root planning on expression of Neuregulin 4 and its receptor ErbB4 in GCF |
In Periodontitis patients without diabetis |
| Comparator Agent |
Effect of scaling and root planning on expression of Neuregulin 4 and its receptor ErbB4 in GCF |
In Periodontitis patients without diabetis |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
GROUP 1:Presence of minimum 16 natural teeth.
Systemically healthy patients with no signs of gingival inflammation defined by
gingival index score<0.5 and without periodontal clinical attachment loss and bone
loss.
group2:
Systemically healthy patients with periodontitis clinically diagnosed based on
American Academy Periodontology (2017) classification 7 having clinical
attachment loss greater than or equal to 3mm in thirty percent of the sites and probing pocket depth greater than or equal to4 mm with at
least 2 teeth.
group 3:
Periodontitis patients (based on American Academy Periodontology 2017
classification) 7 with well controlled T2DM
Patients with type 2 diabetes diagnosed at-least one year prior to the study using
diagnostic criteria of the American Diabetes Association. |
|
| ExclusionCriteria |
| Details |
Patients with any other systemic disease accompanying type 2 DM.
Patients with type 1 DM.
Pregnancy or lactation.
Current or former smokers.
Patients with history of periodontal therapy within past 6 months.
Patients with history of antibiotic intake within past 3 months.
Patients with history of anti-inflammatory drug therapy within 3 months.
Patients taking any other medications excluding medication for DM.
Patients with any intra oral lesions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in neuregulin 4 levels in GCF |
baseline,3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in periodontal parameters,corelatin between neuregulin 4 and diabetes mellitus |
baseline, 3 months |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
29/08/2025 |
| 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="3"
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
|
Written informed consent will be obtained from the patients who are fulfilling the inclusion and exclusion criteria. All the clinical parameters will be recorded at baseline and 3 months after SRP. Patients in groups 1,2 and 3 will receive periodontal therapy in the form of SRP along with oral hygiene instructions (OHI) immediately after the baseline. GCF samples will be collected from the patients at 24-72 hrs after baseline and 3 months after SRP. Neuregulin 4 levels will be measured by ELISA method using commercially available kit. |