| CTRI Number |
CTRI/2022/11/047486 [Registered on: 21/11/2022] Trial Registered Prospectively |
| Last Modified On: |
21/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Semaphorin 4D (SEMA4D) levels in saliva of periodontally healthy and periodontitis patients. |
|
Scientific Title of Study
|
Evaluation and comparison of Semaphorin 4D (SEMA4D) levels in saliva of periodontally healthy and Stage 1 Grade A periodontitis patients and its response to non-surgical periodontal 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 Dipika Mitra |
| Designation |
Professor and Head of the Department |
| Affiliation |
Terna Dental College Hospital |
| Address |
Plot no.12, Terna Dental College and Hospital,Sector-22, Nerul West, Navi Mumbai
Plot no.12, Terna Dental College and Hospital,Sector-22, Nerul West, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9820180406 |
| Fax |
|
| Email |
drdipikamitra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipika Mitra |
| Designation |
Professor and Head of the Department |
| Affiliation |
Terna Dental College Hospital |
| Address |
Plot no.12, Terna Dental College and Hospital,Sector-22, Nerul West, Navi Mumbai
Plot no.12, Terna Dental College and Hospital,Sector-22, Nerul West, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9820180406 |
| Fax |
|
| Email |
drdipikamitra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bela Nagasmal Khobragade |
| Designation |
Post-Graduate Student |
| Affiliation |
Terna Dental College Hospital |
| Address |
Plot no.12, Terna Dental College and Hospital,Sector-22, Nerul West, Navi Mumbai
Plot no.12, Terna Dental College and Hospital,Sector-22, Nerul West, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9970729033 |
| Fax |
|
| Email |
belakhobragade@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Terna Dental College |
| Address |
Plot no.12, Terna Dental College and Hospital,Sector-22, Nerul West, Navi Mumbai |
| Type of Sponsor |
Private medical 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 Bela Khobragade |
Terna Dental College |
Plot no.12, Terna Dental College and Hospital,Sector-22, Nerul West, Navi Mumbai
Thane
MAHARASHTRA |
9970729033
belakhobragade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Terna Dental College Instituitional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Systemically heathly patients with heathly periodontium and with Stage 1 Grade A periodontitis |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Scaling and root planing, Oral hygiene instructions |
All patients with Stage 1 grade A periodontitis will be treated with scaling and root planing in a single sitting followed by oral hygiene instruction. Patients will be recalled after 4 weeks to evaluate the levels of Semaphorins 4D (SEMA4D) in Saliva. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals with good general health and age between 18-60 years.
2. Subjects who have not received periodontal therapy, in the previous six months.
3. Subjects who readily give informed consent for the study.
4. Systemically healthy patients.
5. Subjects with gingival index 0, plaque index 0, clinical attachment level 0 will be included as periodontally healthy.
6. Subjects with gingival index greater then or equal to 1, pocket probing depth less then or equal to 4mm, mostly horizontal bone loss, clinical attachment level 1-2 mm affecting less then or equal to30% teeth involved with radiographic bone loss extending to the coronal-third and no teeth loss due to periodontitis will be included as Stage 1 grade A periodontitis.
|
|
| ExclusionCriteria |
| Details |
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 SEMA4D in saliva of periodontally healthy patients.
2. To determine the level of SEMA4D in saliva of Stage 1 Grade A periodontitis.
3. To compare the level of SEMA4D in saliva of periodontally healthy and Stage 1 Grade A periodontitis.
4. To compare salivary levels of Semaphorin 4D (SEMA4D) before and after scaling and root planing in Stage 1 Grade A periodontitis patients.
|
At baseline and at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To correlate salivary levels of Semaphorin 4D (SEMA4D) with clinical parameters like Plaque Index (PI), Gingival Index (GI),Probing Depth (PD), Clinical Attachment Level (CAL) and Bleeding on Probing (BOP). |
At baseline and at 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/11/2022 |
| 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="2"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE |
|
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 level of Semaphorin 4D (SEMA4D) levels in saliva of periodontally
healthy and Stage 1 Grade A periodontitis patients and its response to
non-surgical periodontal treatment. Based on the
clinical parameters subjects will be categorized into two groups.
•
Group
I (Periodontally Healthy) consisting of 25 subjects with clinically healthy
periodontium and no evidence of disease (GI = 0; PI=0, CAL =0).
•
Group
II (Stage 1 Grade A periodontitis) consisting of 25 subjects with Stage 1 Grade A periodontitis (GI ≥1; PPD >3 mm, CAL >1mm).
•
Group
III (Stage 1 Grade A periodontitis) subjects of group II who will
undergo scaling and root planing and will be re-evaluated after 4 weeks to
re-determine the level of SEMA 4D in saliva. The data obtained will be entered into Microsoft excel spread sheet and will be further analyzed with the help of SPSS software (version 17.0, IBM, USA). |