| CTRI Number |
CTRI/2021/08/035791 [Registered on: 18/08/2021] Trial Registered Prospectively |
| Last Modified On: |
09/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical Trail to explain the need of oral hygiene in gum disease patients |
|
Scientific Title of Study
|
Evaluation Of C-Reactive Protein Levels And Blood Parameters in Chronic Periodontitis patients following non-surgical periodontal therapy: A Clinico-biochemical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Fouzia Imran |
| Designation |
Academic Junior resident |
| Affiliation |
Banaras Hindu University |
| Address |
3rd Floor
Periodontics and Implantology
Faculty of Dental Sciences
Trauma complex
BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9473528583 |
| Fax |
|
| Email |
fouziakhan9474@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Fouzia Imran |
| Designation |
Academic Junior resident |
| Affiliation |
Banaras Hindu University |
| Address |
3rd Floor
Periodontics and Implantology
Faculty of Dental Sciences
Trauma complex
BHU
UTTAR PRADESH
221005
India |
| Phone |
9473528583 |
| Fax |
|
| Email |
fouziakhan9474@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Fouzia Imran |
| Designation |
Academic Junior resident |
| Affiliation |
Banaras Hindu University |
| Address |
3rd Floor
Periodontics and Implantology
Faculty of Dental Sciences
Trauma complex
BHU
UTTAR PRADESH
221005
India |
| Phone |
9473528583 |
| Fax |
|
| Email |
fouziakhan9474@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental Sciences IMS BHU Varanasi |
|
|
Primary Sponsor
|
| Name |
Fouzia Imran |
| Address |
3rd Floor
Periodontology and Implantrology
Faculty of Dental Science
Trauma complex
BHU |
| Type of Sponsor |
Other [Self Sponsoring] |
|
|
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 Sarita Parihar |
Faculty of Dental Science IMS BHU |
Room no 5
Floor no 3
Periodontology and Implantology
Faculty of Dental Sciences
Trauma Complex
IMS BHU
Varanasi
UTTAR PRADESH |
8004925677
drsarita6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IMS BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with Chronic Periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Subjects devoid of Chronic Periodontitis disease |
Blood samples and Salivary samples of subjects who are devoid of any periodontal ailments are collected to assess hs-CRP and CBC levels |
| Intervention |
Subjects who are found out to have Chronic Periodontitis |
Blood samples and Salivary samples of chronic periodontitis patients are collected to assess the levels of hs-CRP and CBC levels at pre-op,7 days and one month following therapy |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. For control group, the participants with at least 20 natural teeth and probing pocket depth of 2–3 mm with no attachment loss and bleeding on probing with <20% sites.
2. For the study group, the participants had to have five qualifying sites in two quadrants with a minimum of two affected teeth in each quadrant with each site having probing depth ≥5 mm, clinical attachment loss (CAL) ≥3 mm, and bleeding on probing.
3. Patients who consented to willingly follow the endorsed plaque control and follow-up routine. |
|
| ExclusionCriteria |
| Details |
1. Medically compromised patients with presence of any systematic disease
2. Pregnant & Lactating women
3. Patients taking any medication for the past 3 months.
4. Patients who are not maintaining their oral hygiene
5. Current smokers. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To show the importance of C-Reactive protein in the maintenance of oral hygiene and to discuss the importance of maintenance of oral hygiene |
pre-op,7 days and 1month following therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To show and study on the importance on C-Reactive protein in chronic periodontitis patients |
pre-op,7days and 1 month following therapy |
|
|
Target Sample Size
|
Total Sample Size="49"
Sample Size from India="49"
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 |
|
Date of First Enrollment (India)
|
25/08/2021 |
| 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="1"
Months="0"
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
|
Chronic periodontitis is a disease characterized by an intense inflammatory infiltrate associated with irreversible loss of alveolar bone and connective tissue attachment in the periodontium which ultimately results in the loss of teeth. The mechanism underlying this destructive process involves both direct tissue damage resulting from plaque bacterial products and indirect damage through bacterial induction in the host cells by an activation of inflammatory mediators such as cytokines, prostaglandins and acute phase proteins. In response to bacteria or endotoxins derived from these periodontal pathogens, several acute phase proteins orchestrate the inflammatory cascade to bring about a balance between host and inflammatory stimuli. One consequence of these inflammatory reactions has been the elevated levels of various acute phase proteins in the serum, plasma, saliva and in gingival crevicular fluid. These acute phase response are initiated by activation of local macrophages and other cells such as fibroblast and endothelial cells, leading to the release of mediators such as Tumor necrosis factor (TNF-α), Interleukin-6 (IL-6) and Interleukin-1β (IL-1β) which in turn stimulate these proteins causing systemic changes.C-reactive protein (CRP) is a very strong acute phase protein produced in the liver and circulates in the blood. It was discovered by Tillett and Francis laboratory in 1930. It is a systemic marker of inflammation induced by various inflammatory stimuli such as trauma, infection and hypoxia. CRP and other acute phase proteins are usually present at low levels in plasma, but may arise dramatically within 72 hours of injury or with infection. It receives much attention as their level guides decision for diagnosis, monitoring and therapy for inflammatory process and associated diseases. It was proved to be a significant predictor of future cardiovascular events.
The main purpose of this study is to compare and to evaluate the serum level of hs-CRP and CBC in moderate and advanced chronic periodontitis patients before and after nonsurgical periodontal treatment correlated with clinical findings.
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