| CTRI Number |
CTRI/2021/03/031919 [Registered on: 11/03/2021] Trial Registered Prospectively |
| Last Modified On: |
10/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of the effect of gum treatment on saliva and blood fetuin-A levels in patients with gum disease |
|
Scientific Title of Study
|
Evaluation of the effect of scaling and root planing on salivary and serum fetuin-a levels in patients with chronic periodontitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjita Nair |
| Designation |
PG Student |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Department of Periodontics Vydehi Intitute of Dental Sciences and Research Centre 82 EPIP area Nallurhalli Whitefield
Department of Periodontics Vydehi Institute of Dental Sciences and Research Centre 82 EPIP area Nallurhalli Whitefield
Bangalore
KARNATAKA
560066
India |
| Phone |
7972143934 |
| Fax |
|
| Email |
sanjita.nair15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha KJ |
| Designation |
Professor and Head |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Department of Periodontics Vydehi Intitute of Dental Sciences and Research Centre 82 EPIP area Nallurhalli Whitefield
Department of Periodontics Vydehi Institute of Dental Sciences and Research Centre 82 EPIP area Nallurhalli Whitefield
Bangalore
KARNATAKA
560066
India |
| Phone |
8105490909 |
| Fax |
|
| Email |
nisharejath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjita Nair |
| Designation |
PG Student |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Department of Periodontics Vydehi Intitute of Dental Sciences and Research Centre 82 EPIP area Nallurhalli Whitefield
Department of Periodontics Vydehi Institute of Dental Sciences and Research Centre 82 EPIP area Nallurhalli Whitefield
Bangalore
KARNATAKA
560066
India |
| Phone |
7972143934 |
| Fax |
|
| Email |
sanjita.nair15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vydehi Institute of Dental Sciences and Research Centre 82 EPIP area Nallurhalli Whitefield Bangalore Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Sanjita Nair |
| Address |
Vydehi Institute of Dental Sciences and Research Centre Whitefield Bangalore 560066 |
| 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 Sanjita Nair |
Vydehi Institute of Dental Sciences and Research Centre |
Department of Periodontics 82 EPIP area Nallurhalli Whitefield
Bangalore
KARNATAKA |
7972143934
sanjita.nair15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vydehi Institute of Dental Sciences and Research Centre ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy subjects with minimal gingival inflammation and no periodontal disease. Patients with chronic periodontitis |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Non-surgical periodontal therapy |
Scaling and root planing in one sitting. Recalled after a duration of 3 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Presence of at least 20 natural teeth
Group 1 healthy individuals having no clinical signs of gingival inflammation, no clinical attachment loss and probing pocket depth less than or equal to 3mm
Group 2 patients who have been clinically diagnosed with generalized moderate to severe chronic periodontitis, otherwise systemically healthy, based on American Academy of Periodontology 1999 classification found to have clinical attachment loss more than or equal to 3mm in 30% of the sites and probing pocket depth more than or equal to 5mm with at least 6 teeth.
|
|
| ExclusionCriteria |
| Details |
Patients with history of any systemic disease
Pregnancy or lactation
Current or former smokers
Patients with history of periodontal therapy in the last 6 months
Patients with history of antibiotic intake in the last 3 months
Patients with history of anti-inflammatory drug therapy in the last 3 months
Patients consuming any other medications
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 |
| Salivary and serum fetuin-A levels. Probing pocket depth clinical attachment level bleeding on probing |
Baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival index plaque index |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Periodontitis is a site-specific inflammatory condition of the tooth
supporting structures inciting soft tissue destruction and alveolar bone loss.
The nexus between different complex cascades generates pro-inflammatory cytokines
that in turn activate hepatocytic receptors to commence the synthesis of
varying Acute Phase Proteins (APPs) as part of the non-specific Acute Phase
Response (APR). APPs are customarily classified as positive and negative based
on their serum concentrations. Hence, they exhibit both pro-inflammatory and
anti-inflammatory properties. Various positive and negative APPs have been
studied in relation to periodontal disease. One such negative APP, fetuin-A has
garnered colossal recognition in the etio-pathogenesis of several systemic
disorders. It has been recently discovered as an anti-inflammatory marker for periodontal
disease and has coerced researchers to delve into its prospective as a
diagnostic and a prognostic marker for periodontal disease. |