| CTRI Number |
CTRI/2024/07/070634 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To compare the levels of Creatinine and Alkaline Phosphatase in blood in patients suffering from Chronic gum disease with and without Type 2 Diabetes Mellitus Before and After Scaling and Root Planing. |
|
Scientific Title of Study
|
Comparative Evaluation of Serum Creatinine and Alkaline Phosphatase levels in Chronic Periodontitis Patients with and without Type 2 Diabetes Mellitus Before and After Scaling and Root Planing- A Clinico-biochemical Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shruti Meshram |
| Designation |
First Year Post Graduate MDS, Department of Periodontics |
| Affiliation |
Nair hospital Dental College, Mumbai |
| Address |
Room no.201,Department of Periodontics Nair Hospital Dental
College
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9975981698 |
| Fax |
|
| Email |
shrutimeshram1614@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praneeta Kamble |
| Designation |
Associate Professor |
| Affiliation |
Nair hospital Dental College, Mumbai |
| Address |
Room no.201,Department of Periodontics Nair Hospital Dental
College
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9820263468 |
| Fax |
|
| Email |
drpraneetakamble@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praneeta Kamble |
| Designation |
Associate Professor |
| Affiliation |
Nair hospital Dental College, Mumbai |
| Address |
Room no.201,Department of Periodontics Nair Hospital Dental
College
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9820263468 |
| Fax |
|
| Email |
drpraneetakamble@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Shruti Meshram Room no. 201, Nair Hospital Dental College, Mumbai, 400008, Maharashtra,
India
|
|
|
Primary Sponsor
|
| Name |
Dr Shruti Meshram |
| Address |
Room no. 1107 Nair Hospital Dental College Hostel, opposite Maratha Mandir Mumbai Central. 400008 |
| 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 Shruti Meshram |
Nair Hospital Dental College,Mumbai |
Room 201, department
of Periodontics, second
floor, Nair Hospital
Dental College, Mumbai
Central 400008,
Maharashtra
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9975981698
shrutimeshram1614@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Nair Hospital Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Scaling and Root planing |
Scaling and Root planing in chronic periodontitis patients
Duration for this will be 6 months |
| Comparator Agent |
Serum creatinine and alkaline phosphatase |
To evaluate serum creatinine and alkaline phosphatase levels before and after scaling and root planing
Duration of this will be 6 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Group A: Periodontally healthy patients with no clinical gingival inflammation and GI equal to 0, probing depth (PPD) less than or equal to 3 mm, and no radiographic evidence of bone loss
Group B: Chronic periodontitis patients without T2DM with GI greater than 1, PPD greater than or equal to 6mm and CAL greater than or equal to 5mm.
Group C: Chronic periodontitis patients with T2DM patients, GI greater than 1, PPD greater than or equal to 6mm and CAL greater than 5mm. HbA1c levels between 5-7%.
|
|
| ExclusionCriteria |
| Details |
1. Patients who have undergone any periodontal therapy in the past 6 months.
2. Patients with symptoms of acute illness.
3. Patients who are on immunosuppressive therapy or having any other systemic illness.
4 Systemic anti-inflammatory treatment within the previous 3 months or regular use of specific drugs known to affect periodontal tissues.
5. Pregnant women and lactating mothers.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
BIOCHEMICAL PARAMETERS
1) Fasting plasma glucose (FPG)
2) Post Prandial plasma glucose (PPG)
3) HbA1c
4) Creatinine
5) Alkaline phosphatase
CLINICAL PARAMETERS
1.Plaque Index (P.I.) (Tureskey-Gilmore-Glickman Modification of Quigley Hein)
2.Gingival Index (G.I.) (Loe and Silness, 1963)
3.Probing Pocket Depth (PPD)
4.Clinical Attachment Level (CAL)
|
At baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| serum Alkaline phosphatase and serum creatinine levels in normal people and in people suffering from type 2 diabetes mellitus |
serum Alkaline phosphatase and serum creatinine levels before scaling and root planing and 4 weeks post scaling and root planing |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/12/2024 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim and Objective To evaluate and compare the
serum creatinine and alkaline phosphatase levels in chronic periodontitis
patients with and without T2DM. Material and Methods The patients selected as
per the inclusion and exclusion criteria, will be allotted into 3 groups, Group
A, Group B and Group C Group
A :
22 Periodontally and systemically healthy patients
Group B : 22 Chronic periodontitis patients
without T2DM
Group C :
22 Chronic periodontitis patients with
T2DMAfter initial examination and taking informed consent from the patient 2ml blood with be taken followed by scaling and root planing o the patient and blood sample will be sent to assess the serum ALP and creatinine levels. The patient will be recalled after 4 weeks , after reviewing the periodontal status 2 ml of blood sample will be taken to assess serum ALP and creatinine. Data
collected will be compiled on to a MS Office excel worksheet & will be
subjected to statistical analysis using an appropriate package like SPSS
software.
Normality of
numerical data will be checked using Shapiro – Wilk test or Kolmogorov-Smirnov
test. Depending on the normality of data, statistical tests will be determined.
For a
numerical continuous data following a normal distribution, inter group
comparison (>2 groups) will be done using one way ANOVA test, else a non
parametric substitute like Kruskall Wallis ANOVA test will be used.
Descriptive statistics like frequency (n)
& percentage (%) of categorical data, mean & Standard deviation of
numerical data in each group will be depicted & may be compared using chi
square test. Keeping alpha
error at 5% and Beta error at 20%, power at 80%, p<0.05 will be considered
statistically significant.
|