| CTRI Number |
CTRI/2020/12/029934 [Registered on: 18/12/2020] Trial Registered Prospectively |
| Last Modified On: |
11/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Investigation of Semaphorin 4D Levels in gingival crevicular fluid of healthy gums and in pyorrhea and it’s response to teeth cleaning treatment . |
|
Scientific Title of Study
|
Evaluation and Comparison of Semaphorin 4D (SEMA4D) Levels
in gingival crevicular fluid (GCF) of periodontally healthy, diseased
subjects and it’s response to treatment : A Clinico-Biochemical
Interventional 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 Rohit Shah |
| Designation |
Reader |
| Affiliation |
Terna dental college and hospital |
| Address |
Department of
periodontics ,room no.
103 .Terna dental
college and hospital
,plot no.12 , sector 22 ,
opposite nerul west
railway station
,navimumbai ,
maharashtra
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9699860609 |
| Fax |
|
| Email |
rohitshah17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohit Shah |
| Designation |
Reader |
| Affiliation |
Terna dental college and hospital |
| Address |
Department of
periodontics ,room no.
103 .Terna dental
college and hospital
,plot no.12 , sector 22 ,
opposite nerul west
railway station
,navimumbai ,
maharashtra
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9699860609 |
| Fax |
|
| Email |
rohitshah17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Patil |
| Designation |
PG Student |
| Affiliation |
Terna dental college and hospital |
| Address |
Department of
periodontics ,room no.
103 .Terna dental
college and hospital
,plot no.12 , sector 22 ,
opposite nerul west
railway station
,navimumbai ,
maharashtra
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA
400706
India |
| Phone |
7709744129 |
| Fax |
|
| Email |
shrutipatil824@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
TPCTs Terna dental college and hospital |
| Address |
Terna dental college and hospital ,plot no.12 , sector 22 , opposite
nerul west railway station ,navimumbai , maharashtra
|
| Type of Sponsor |
Other [Private dental college] |
|
|
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 Patil |
TPCTs Terna Dental College |
Department of
periodontics, room number
103,Plot Number 2,
Sector 22, Opposite Nerul
West Railway Station,
Nerul West, Navi
Mumbai, Maharashtra
400706 Mumbai
Mumbai
MAHARASHTRA |
7709744129
shrutipatil824@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Terna Dental College Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Systemically healthy patients with healthy
periodontium and patients with chronic
periodontitis
|
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Scaling and root planing
Oral hygiene instructions |
All patients with chronic
periodontitist will be treated with
scaling and root planing in a
single sitting followed by oral
hygiene instructions. Patient will
be recalled after 4 weeks to
evaluate the GCF SEMA4D
levels. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects between the age group of 30 – 60 years.
2.Subjects who have not received periodontal therapy, within
preceding six months.
3.Subjects who readily give informed consent for the study.
4.Systemically healthy patients . |
|
| ExclusionCriteria |
| Details |
1.Consumption of tobacco in any form and alcoholics.
2.Pregnant and lactating females.
3. Subjects who have received anti-inflammatory, antibiotic and
steroid drugs in previous three months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To determine the level of GCF SEMA4D in
periodontally healthy patients.
2.To determine the level of GCF SEMA4D in
chronic periodontitis patients.
3.To compare the levels of GCF SEMA4D in
periodontally healthy and chronic periodontitis
patients.
4.To correlate the effect of scaling and root
planing on the level of GCF SEMA4D in
patients with chronic periodontitis.
|
Baseline
4 weeks after scaling and root planing |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate improvement in plaque index
,gingival index,pocket probing depth and clinical
attachment level in patients with chronic
periodontitis 4 weeks after scaling and root
planing . |
plaque index ,gingival index,pocket probing
depth and clinical attachment level in patients
with chronic periodontitis will be taken at
baseline and then 4 weeks after scaling and root
planing . |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2021 |
| Date of Study Completion (India) |
11/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a clinico biochemical interventional study to compare the GCF SEM4D levels in periodontally healthy, patients with chronic periodontitis and its response to scaling and root planing.
Study design: Group I (Periodontally healthy) consisting of 25 subjects with clinically healthy periodontium and no evidence of disease (GI equal to 0, PPD equal to or less than 3 mm, CAL equal to 0)
Group II (Chronic periodontitis) consisting of 25 subjects with chronic periodontitis (GI greater than 1, PPD greater than 3 mm, CAL greater than 1mm)
GCF samples will be collected from all subjects to evaluate the GCF SEMA4D levels.
The subjects of group II will undergo scaling and root planing and will be re-evaluated after 4 weeks to re-determine the SEMA4D levels. The data will be entered into Microsoft excel sheet and will be further analyzed with the help of SPSS software. |