| CTRI Number |
CTRI/2018/01/011282 [Registered on: 11/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
22/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Cleaning and gum surgery effect in disease patients |
|
Scientific Title of Study
|
Effect of Scaling and Root Planing and Open Flap Debridement Therapy on Salivary Total Protein Levels in Generalised Chronic Periodontitis Patients - A Clinical and Biochemical Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shraddha Kode |
| Designation |
First Year Postgraduate Student |
| Affiliation |
Nair Hospital Dental College |
| Address |
202, Department Of Periodontology, Nair Hospital Dental College, A.L.Nair Road, Opposite Maratha Mandir, Mumbai Central, Mumbai - 08.
Mumbai
MAHARASHTRA
400605
India |
| Phone |
9773752150 |
| Fax |
|
| Email |
kshraa24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praneeta Kamble |
| Designation |
Additional Professor |
| Affiliation |
Nair Hospital Dental College |
| Address |
202, Department Of Periodontology, Nair Hospital Dental College, A.L.Nair Road, Opposite Maratha Mandir, Mumbai Central, Mumbai - 08.
Mumbai
MAHARASHTRA
400605
India |
| Phone |
9820263468 |
| Fax |
|
| Email |
drpraneetakamble@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shraddha Kode |
| Designation |
First Year Postgraduate Student |
| Affiliation |
Nair Hospital Dental College |
| Address |
S/3 A Chitralekha, Vikram Nagar, Kalwa(w). Dist - Thane.
202, Department Of Periodontology, Nair Hospital Dental College, A.L.Nair Road, Opposite Maratha Mandir, Mumbai Central, Mumbai - 08.
Mumbai
MAHARASHTRA
400605
India |
| Phone |
9773752150 |
| Fax |
|
| Email |
kshraa24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self sponsored
ADD: S/3A Chitralekha, Vikram Nagar, Kalwa (w). Dist - Thane 400605 |
|
|
Primary Sponsor
|
| Name |
Dr Shraddha Kode |
| Address |
S/3 A Chitralekha, Vikram Nagar, Kalwa(w). Dist - Thane 400605 |
| 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 Shraddha Kode |
Nair Hospital Dental College, Mumbai |
202, Department of Periodontology, Nair Hospital Dental College, Opposite Maratha Mandir, Mumbai Central, Mumbai - 08.
Mumbai
MAHARASHTRA |
9773752150
kshraa24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAHARASHTRA UNIVERSITY OF HEALTH SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Chronic Periodontitis Patients, (1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Effect of non-surgical and surgical periodontal therapy on salivary total protein levels in chronic periodontitis patients. |
Non surgical therapy includes scaling and root planing. Surgical therapy includes open flap debridement therapy. Total protein levels will be estimated by biochemical analysis - The Lowry method. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with generalised chronic periodontitis and probing pocket depth of 4mm or more in more than 30% of sites
2. Subjects with minimum complement of 20 natural teeth
3. Systemically healthy individuals with no underlying medical conditions |
|
| ExclusionCriteria |
| Details |
1. Patients with history of salivary gland diseases and apparent oral infections
2. Subjects with injuries or bleeding in the oral cavity unrelated to gingivitis or periodontitis
3. Subjects with intake of antibiotics or anti-inflammatory drugs within 6 months prior to the study
4. Patients with history of past periodontal therapy
5. Patients on protein supplements
6. Pregnant and lactating females
7. Smokers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Salivary total protein levels are high in chronic periodontitis patients. The periodontal therapy reduces the levels of salivary total proteins which further improved the protein function in the body. |
Total time period is 20 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Salivary total proteins can be considered as a risk factor of health. So periodontal therapy can be used as a preventive measure for improving the overall health by correcting the risk factor. |
Total time period is 20 months. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
25/10/2016 |
| 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) |
Open to Recruitment |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Periodontal disease is a chronic inflammatory disease which elevates the levels of salivary total proteins. Hence, the aim of the study is to evaluate the effect of periodontal therapy on the salivary total protein levels so as to maintain the overall health of the patients.Pathologic periodontal pockets will be treated thereby eliminating the diseased condition. If salivary total protein levels decrease after periodontal therapy it will help you improve the protein function in the body which is very important for the general health of the patient. |