CTRI Number |
CTRI/2013/05/003660 [Registered on: 21/05/2013] Trial Registered Retrospectively |
Last Modified On: |
25/09/2013 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Preventive Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
non-surgical periodontal therapy in type II diabetic patients |
Scientific Title of Study
|
Effect of non-surgical periodontal therapy on glycaemic control in type II diabetic patients: A randomized controlled clinical trial. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DrRavishankar TL |
Designation |
Associate Professor |
Affiliation |
kothiwal dental college and research centre |
Address |
kothiwal dental college and research centre, kanth road, moradabad kothiwal dental college and research centre, kanth road, moradabad Moradabad UTTAR PRADESH 244001 India |
Phone |
9219612715 |
Fax |
|
Email |
telgiravi@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
DrRavishankar TL |
Designation |
Associate Professor |
Affiliation |
kothiwal dental college and research centre |
Address |
kothiwal dental college and research centre, kanth road, moradabad kothiwal dental college and research centre, kanth road, moradabad Moradabad UTTAR PRADESH 244001 India |
Phone |
9219612715 |
Fax |
|
Email |
telgiravi@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
DrRavishankar TL |
Designation |
Associate Professor |
Affiliation |
kothiwal dental college and research centre |
Address |
kothiwal dental college and research centre, kanth road, moradabad kothiwal dental college and research centre, kanth road, moradabad Moradabad UTTAR PRADESH 244001 India |
Phone |
9219612715 |
Fax |
|
Email |
telgiravi@yahoo.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
vaibhav tandon |
Address |
kothiwal dental college, kanth road , moradabad. |
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 |
Vaibhav Tandon |
Diabetic Centre |
Lajpatnagar Moradabad Moradabad UTTAR PRADESH |
9319082837
vaibhavtandon35@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
ethical committe on human/animal subjects research / Moradabad/ Dr.Chaubey |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
diabetic and mild periodontitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Non-Surgical periodontal therapy, mouthwash, brushing |
Non-surgical Periodontal therapy leads to removal of necrotic tissue,which leads in reduction of gingival inflammation which in turn causes reduction in inflammatory cytokinines nd other chemical mediators of inflammation |
Comparator Agent |
Only brushing |
Regular brushing removes the plaque by mechanical debridement, which causes removal of the bacteria present in plaque and calculus and leads to reduction in gingival inflammation. |
|
Inclusion Criteria
|
Age From |
35.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Both |
Details |
Blood sugar controlled only with oral hypoglycaemic agents and no systemic antibiotic administration or periodontal treatment within the last six months. |
|
ExclusionCriteria |
Details |
Patients with systemic diseases other than Diabetes Mellitus type II, tobacco and alcohol users and patients who were suffering from oral disease that need emergency treatment like endo-perio lesion, periodontal abscess. |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Glycated Haemoglobin(HbA1c)in% |
data will be recorded at baseline and after 3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Probing Pocket Depth(PPD)in mm,
Plaque Index (PI) ,
Gingival Index(GI) |
data will be recorded at baseline and after 3 month of intervention |
|
Target Sample Size
|
Total Sample Size="100000" Sample Size from India="100000"
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 3 |
Date of First Enrollment (India)
|
25/03/2013 |
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="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
INTRODUCTION
Diabetes
mellitus (DM) is a chronic, non-communicable disease and also one of the major
global public health issues. It is defined as a clinical syndrome characterized
by hyperglycemia due to the defect in insulin secretion by pancreatic β cells,
decrease in insulin sensitivity, or a combination of both. The most common form
of DM is Diabetes mellitus type 2 (DM2), which accounts for 85% of all diabetes
patients.1 Periodontal
disease is the most prevalent oral complication in patients with type 2
diabetes mellitus. Periodontitis is a disease characterized by periodontal
pocket formation, loss of connective tissue attachment, alveolar bone
resorption, and gingival inflammation, ultimately resulting in tooth loss.
The observation that periodontal therapy appears to
reduce periodontal infection and inflammation, suggests that periodontal
therapy may facilitate metabolic control of diabetes, improving insulin
sensitivity by reducing peripheral inflammatory cytokines levels.2 Therefore,
we put on the hypothesis that if periodontitis is casually related to worsening
of parameters of diabetic patients, then periodontal treatment should improve
glycaemic control.
The aim of the study is to investigate
the effects of non- surgical periodontal therapy on glycaemic control in DM2
patients.
METHODOLOGY
Convenient
sample of 60 patients aged 35-45 years will be selected from a Diabetic Centre
in Moradabad. Patient who came to Diabetic Centre for their routine check up
and investigation will screen for type II Diabetes Mellitus and Periodontitis.
This study was revived and approved by the
institutional Ethical Review Committee, Moradabad.
The
inclusion criteria include; Blood sugar controlled only with oral hypoglycaemic
agents and no systemic antibiotic administration or periodontal treatment
within the last six months. The exclusion criteria includes; Patients with systemic diseases other than Diabetes
Mellitus type II, tobacco and alcohol users and
patients who were suffering from oral disease that need emergency
treatment like endo-perio lesion, periodontal abscess.
The
oral examination will be conducted in dental clinical wing of the diabetic centre.
Oral examination includes assessing periodontal Pocket Depth, Gingival status
and Plaque accumulation of each individual patient. Periodontal pocket depth
was assessed by measuring Probing pocket depth(PPD) with UNC-15 probe at six
points for each tooth and the arithmetic mean value of all the teeth was
considered. Gingival status was assessed by Gingival Index, Loe & Silness
(1963). Dental plaque was assessed by Plaque Index, Silness & Loe(1967).
Glycemic
status will be assesses by the HbA1c and fasting blood sugar level.
Participating subjects were interviewed for the demographic data, duration and
the frequency of a drug and were cross verified with the hospital records. |