| CTRI Number |
CTRI/2018/02/011970 [Registered on: 19/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
15/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Health of gums effecting health of heart in heart disease. |
|
Scientific Title of Study
|
Evaluation of periodontal status among patients with coronary heart disease- effect of scaling and root planing on their periodontal and cardiovascular (clinical and biochemical) status |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Singh Hada |
| Designation |
PG Student |
| Affiliation |
Government College of Dentistry Indore |
| Address |
Room No 10, Department of Periodontology, Government College of Dentistry, Indore, MP
Indore
MADHYA PRADESH
452001
India |
| Phone |
8720898289 |
| Fax |
|
| Email |
dr_dshada@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SUBHASH GARG |
| Designation |
Guide |
| Affiliation |
Government College of Dentistry Indore |
| Address |
Room No. 10, Department of Periodontology, Government College of Dentistry Indore, MP
Indore
MADHYA PRADESH
452001
India |
| Phone |
8720898289 |
| Fax |
|
| Email |
drsubhashgarg@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Singh Hada |
| Designation |
PG Student |
| Affiliation |
Government College of Dentistry Indore |
| Address |
Room No. 10, Department of Periodontology, Government College of Dentistry, Indore, MP
Indore
MADHYA PRADESH
452001
India |
| Phone |
8720898289 |
| Fax |
|
| Email |
dr_dshada@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology,
Government College of Dentistry,
Indore, MP |
|
|
Primary Sponsor
|
| Name |
Dr Divya Singh Hada |
| Address |
Room No.10, Department of Periodontology, Government College of Dentistry, Indore MP |
| 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 |
| Dr Divya Singh Hada |
Government College of Dentistry |
Room no. 10, Department of Periodontology
Indore
MADHYA PRADESH |
8720898289
dr_dshada@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Coronary heart disease, Periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
SCALING AND ROOT PLANING |
Periodontal intervention in the form of non surgical periodontal treatment (scaling and root planing) is provided to the CHD patients belonging to the experimental group . |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Male/Female more than 35 yrs of age, clinically diagnosed stable CHD cases, including stable angina, non ST elevation myocardial infarction, ST elevation myocardial infarction, not suffering from any other systemic disease, non-smoker, more than 14 teeth (excluding third molars), with advanced chronic gingivitis and mild to moderate chronic periodontitis (more than or equal to 4 teeth with probing depth less than or equal to 5mm), not undergone any periodontal therapy in the last 12 months formed the basis of inclusion. |
|
| ExclusionCriteria |
| Details |
not fulfilling criteria of the defined CHD case, present smoker, pregnant or lactating females, suffering from any other systemic disease like diabetes, taking systemic antibiotic therapy in the last 3 months, less than 14 teeth (excluding third molars), with advanced chronic periodontitis (probing depth > 5mm), received any periodontal therapy within last 12 months. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| C-reactive protein, lipid profile, blood pressure, WBC count |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| C reactive protein, WBC count, lipid profile, BP, periodontal parameters |
Baseline, 01 month, 03 month |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "55"
Final Enrollment numbers achieved (India)="55" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2013 |
| Date of Study Completion (India) |
13/08/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
D’Aiuto F, Parkar M, Nibali L, Suvan J, Lessem J, Tonetti MS. Periodontal infections cause changes in traditional and novel cardiovascular risk factors: results from a randomized controlled clinical trial. American Heart Journal 2006;151:977–984. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, outcome assessor blinded, parallel group, trial to evaluate the effect of non surgical periodontal treatment in the form of scaling and root planing on coronary heart disease patients. 70 CHD patients with periodontitis, were allocated into two groups- experimental and control. Scaling and root planing was provided as the intervention to the experimental group. The primary outcome are the changes in C-reactive level and systolic blood pressure at the end of 6 months. The secondary outcomes are blood pressure, pulse, respiratory rate, C-reactive protein, lipid profile, WBC profile at baseline, 1, 3, and 6 months. Periodontal parameters including PI, GI, BOP, PPD, and CAL is also assessed at baseline and 6 months. All these parameters were also compared with their corresponding values in the control group. |