| CTRI Number |
CTRI/2019/11/021944 [Registered on: 11/11/2019] Trial Registered Prospectively |
| Last Modified On: |
08/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of Periodontal Treatment on Stress levels in Chronic Kidney Disease Patients suffering from Periodontitis |
|
Scientific Title of Study
|
Effect of Periodontal Intervention on Oxidative Stress in Chronic Kidney Disease Patients suffering from Moderate to Severe Periodontitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUHANI MAHESHWARI |
| Designation |
Post graduate student |
| Affiliation |
Dr. Harvansh Singh Judge Institute Of Dental Sciences and Hospital |
| Address |
Room no 108 Dept of Periodontics first floor
Dr Harvansh Singh Judge Institute Of Dental Sciences and Hospital
Panjab University
Chandigarh
Room no 108 Dept of Periodontics first floor
Dr Harvansh Singh Judge Institute Of Dental Sciences and Hospital
Panjab University
Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
9899540075 |
| Fax |
|
| Email |
suhanibds1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Jain |
| Designation |
Professor and Head Department of Periodontology |
| Affiliation |
Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital Panjab University Chandigarh. |
| Address |
Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital Panjab University Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
9888000444 |
| Fax |
|
| Email |
ashish@justice.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Jain |
| Designation |
Professor and Head Department of Periodontology |
| Affiliation |
Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital Panjab University Chandigarh. |
| Address |
Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital Panjab University Chandigarh
Central
CHANDIGARH
160014
India |
| Phone |
9888000444 |
| Fax |
|
| Email |
ashish@justice.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Suhani Maheshwari |
| Address |
pocket B-2 house no 124 125 sec-6 Rohini Delhi |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Suhani Maheshwari |
Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital Panjab University Chandigarh |
Department of Periodontics room no 108 first floor
Chandigarh
CHANDIGARH |
9899540075
suhanibds1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee Panjab University Chandigarh(PUIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oral Hygiene instructions |
Control Group(CKD patients who refuse to receive the periodontal treatment) receive oral hygiene instructions |
| Intervention |
Surgical and non surgical periodontal treatment at baseline |
Test Group receive non surgical and surgical periodontal treatment as required and oral hygiene instructions at baseline |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age range: 30-60 years
Chronic Kidney Disease
Patients suffering from moderate to severe periodontitis
Non-smoking (former smokers were included if they had not smoked within 6 months of the study initiation)
No periodontal therapy within previous 6 months.
Patients who give consent
Patients with minimum 20 teeth
|
|
| ExclusionCriteria |
| Details |
History of atherosclerosis involving the coronary cerebral or peripheral vascular systems
Experiencing a cardiovascular event (myocardial infarction or stroke) or undergoing coronary angioplasty or peripheral intervention procedure between the Screening Visit and randomization
Undergoing any cardiovascular surgery (valvular surgery) within 3 months of study participation Planned revascularization or peripheral intervention procedure or other cardiovascular surgery
New York Heart Association (NYHA) Class III or IV heart failure at study participation
Patient of End stage renal disease (ESRD)/ patients on hemodialysis or peritoneal dialysis
Patients chronically treated (i.e 2 week or more) with any medication that affect periodontal status (i.e antibiotics or non-steroidal anti-inflammatory drugs) or lipid peroxidation with clinically significant or unstable organic diseases or compromised healing potential (i.e. connective tissue disorders or bone metabolic diseases).
Pregnant women or lactating.
Patients affected by active infectious diseases Asthma Diabetes Immune-compromised or taking steroid medications.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in the level of lipid peroxides-Malondialdehyde (MDA) after periodontal intervention in CKD.
Renal Function will be assessed by ACR (Albumin Creatinine Ratio)
|
Change in the level of lipid peroxides-Malondialdehyde (MDA) after periodontal intervention in CKD.
Renal Function will be assessed by ACR (Albumin Creatinine Ratio)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical parameters-Probing Depth (PD) CAL (Clinical attachment Loss) Plaque index(PI) Gingival Index(GI).
Change in the level of Inflammatory stress markers after periodontal intervention
|
baseline 6 months and 12 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/11/2019 |
| 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="2"
Days="2" |
|
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)?
|
|
Brief Summary
|
Chronic Periodontitis is an inflammatory disease that cause destruction of periodontal connective tissue , loss of periodontal attachment ,and resorption of alveolar bone. The interaction between the pathogen and host defensive capacity result in periodontal tissue breakdown. Chronic kidney disease(CKD) causes the gradual loss of kidney function over time. Neutrophils become the most common inflammatory cells gathering in periodontal tissue and gingival sulcus, and they are believed to be the preÂdominant source of ROS in periodontitis and leads to damage of Periodontal tissue by oxidising DNA, lipids and proteins. So CKD is a low grade inflammatory process and chronic inflammation can itself lead to increased oxidative stress in advanced renal disease Periodontitis has also been shown to increase oxidative stress. Literature has shown that treating oxidative stress improves Chronic Kidney Disease. In Independent studies it has also been documented that reduced oxidative stress has resolutory role on periodontitis. The effect of reduction in the oxidative stress by treating periodontal disease on CKD status has not been studied so far. The rationale of the present study is to evaluate role of periodontal therapy in Chronic Kidney Disease by improving Oxidative Stress. After a detailed clinical and blood examination the subjects with CKD and Periodontitis will be included as per inclusion and exclusion criteria GCF and serum samples will be obtained and appropriate periodontal intervention and comparison will be provided . Than compiled data will be analysed statistically. |