| CTRI Number |
CTRI/2022/04/042292 [Registered on: 29/04/2022] Trial Registered Prospectively |
| Last Modified On: |
11/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
The comparison of salivary levels of specialised pro-resolving mediators,resolvins and lipoxin among smokers and non-smokers before and after non-surgical periodontal therapy |
|
Scientific Title of Study
|
EFFECT OF PERIODONTAL THERAPY ON THE SALIVARY LEVELS OF RESOLVINS(RvE1) AND LIPOXINS(LXA4) IN PERIODONTITIS PATIENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arthi I |
| Designation |
Postgraduate student |
| Affiliation |
SRM DENTAL COLLEGE AND HOSPITAL |
| Address |
Department Of Periodontics
SRM Dental College And Hospital
Barathi Salai
Ramapuram
Chennai 600089
Department Of Periodontics
SRM Dental College And Hospital
Barathi Salai
Ramapuram
Chennai 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
8610368835 |
| Fax |
|
| Email |
ashwiniarthi26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeetha S |
| Designation |
Professor |
| Affiliation |
SRM Dental College And Hospital |
| Address |
Department Of Periodontics
SRM Dental College And Hospital
Barathi Salai
Ramapuram
Chennai 600089
Department Of Periodontics
SRM Dental College And Hospital
Barathi Salai
Ramapuram
Chennai 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
9884563217 |
| Fax |
|
| Email |
sangeetha_doc@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Arthi I |
| Designation |
Postgraduate student |
| Affiliation |
SRM Dental College And Hospital |
| Address |
Department of Periodontics
SRM Dental College And Hospital
Bharathi Salai
Ramapuram
Chennai 600089
Chennai
TAMIL NADU
600095
India |
| Phone |
8610368835 |
| Fax |
|
| Email |
ashwiniarthi26@gmail.com |
|
|
Source of Monetary or Material Support
|
| SELF FUNDED
ARTHI I
3 CHOKALINGAM STREET
EAST SHANMUGAPURAM COLONY
VILLUPURAM 605602 |
|
|
Primary Sponsor
|
| Name |
ARTHI I |
| Address |
3 CHOKALINGAM STREET
EAST SHANMUGAPURAM COLONY
VILLUPURAM 605602 |
| 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 |
| ARTHI I |
SRM DENTAL COLLEGE AND HOSPITAL |
DEPARTMENT OF PERIODONTICS
BARATHI SALAI
RAMAPURAM
CHENNAI 600089
Chennai
TAMIL NADU |
8610368835
ashwiniarthi26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD, SRM DENTAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY HUMAN VOLUNTEERS WITH PERIODONTITIS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Non Surgical Periodontal Therapy |
To compare the salivary levels of Resolvins and Lipoxins at baseline and six weeks after non surgical periodontal therapy among smokers and non-smokers with periodontitis
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
1.Patients with more than 20 teeth
2.Current cigarette smokers ≤ 10 cigarettes per day
3.Periodontitis patients with probing pocket depth(PPD) ≥ 5mm and interdental clinical attachment level(CAL) ≥4mm
4.Patients who are complying with oral hygiene instructions and periodontal recall
5.Patients who are willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women
2.Patients using medication affecting the periodontal status.
3.Patients with history of periodontal therapy for the past six months
4.Patients with inflammatory disorders such as rheumatoid arthritis, diabetes mellitus, COPD, inflammatory bowel disease etc.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SALIVARY LEVELS OF RESOLVIN AND LIPOXIN BEFORE AND AFTER NON-SURGICAL PERIODONTAL THERAPY |
AT BASELINE AND 4 WEEKS AFTER NON SURGICAL PERIODONTAL THERAPY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the salivary levels of resolvins and lipoxins before and after non-surgical periodontal therapy between smokers and non-smokers and to correlate it with clinical parameters.
|
AT BASELINE AND 4 WEEKS AFTER NON SURGICAL PERIODONTAL THERAPY |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2022 |
| Date of Study Completion (India) |
20/10/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
ON GOING |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Periodontitis is an immunoinflammatory
disease of the supporting structures of the dentition which is initiated by perio-pathogens that triggers the cells
of the immune system to release proinflammatory mediators resulting in
inflammation and destruction of the periodontium. The primary goal of the periodontal
therapy is to ensure resolution of inflammation and restoration of the tissue
homeostasis. Cigarette smoking is known to be a major
risk factor for periodontal disease and also affects the healing response of patients
after periodontal therapy. A ‘programmed resolution’ at the tissue
level has been actively driven by several specialized lipid immune resolvents
including resolvins and lipoxins. The role of resolvins and lipoxins in response to non-surgical
periodontal therapy has not been elucidated in smokers with periodontitis.
Further, salivary levels of resolvins (RvE1) and lipoxins (LXA4) and
their association with periodontal therapy among smokers and non-smokers has
not been studied. Therefore, in this study, we aim to
evaluate and compare the salivary levels of resolvins (RvE1) and lipoxins (LXA4) in
periodontitis patients before and after non-surgical treatment between smokers
and non-smokers. Most metabolites, cytokines, products of
inflammation including RvE1 and LXA4 ongoing in periodontium move in a certain
amount by passive filtration into saliva and their levels in saliva reflect
their levels in plasma. |