| CTRI Number |
CTRI/2025/07/089926 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Salivary biomarkers levels in obese and non-obese patients with pyorrhea |
|
Scientific Title of Study
|
DETERMINING THE SALIVARY MMP-8 LEVELS IN OBESE & NON-OBESE SUBJECTS WITH AND WITHOUT PERIODONTITIS: A PROSPECTIVE 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 Prajjwal Shahi |
| Designation |
Postgraduate Student |
| Affiliation |
Manav Rachna International institute Research and Studies |
| Address |
Room no 8 Department of Periodontology Third floor Manav Rachna Dental College SDS
Sector 43 Delhi Suraj Kund Badkhal Road Faridabad Haryana
Faridabad
HARYANA
121004
India |
| Phone |
9073104356 |
| Fax |
|
| Email |
prajjwalshahi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Palwankar |
| Designation |
Professor and Head |
| Affiliation |
Manav Rachna International institute Research and Studies |
| Address |
Room no-8 Department of Periodontology Third floor Manav Rachna Dental College SDS MRIIRS Sector 43 Delhi Suraj Kund Badkhal Road Faridabad Haryana
Faridabad
HARYANA
121004
India |
| Phone |
9891175112 |
| Fax |
|
| Email |
pooja.sds@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prajjwal Shahi |
| Designation |
Postgraduate Student |
| Affiliation |
Manav Rachna International institute Research and Studies |
| Address |
Room no 8 Department of Periodontology Third floor Manav Rachna Dental College SDS MRIIRS Sector 43 Delhi SurajKund Badkhal Road Faridabad Haryana
Faridabad
HARYANA
121004
India |
| Phone |
9073104356 |
| Fax |
|
| Email |
prajjwalshahi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Prajjwal Shahi
Post graduate student
Department of Periodontology
Manav Rachna Dental College SDS MRIIRS
Sector – 43 Delhi Suraj Kund Badkhal Rd Faridabad Haryana 121004 |
|
|
Primary Sponsor
|
| Name |
Dr Prajjwal Shahi |
| Address |
Manav Rachna Dental College SDS MRIIRS Sector – 43 Delhi Suraj Kund Badkhal Rd Faridabad Haryana 121004 |
| 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 Prajjwal Shahi |
Manav Rachna Dental College |
Department of Periodontology room no.8 Manav Rachna Dental College SDS MRIIRS Sector 43 Delhi Suraj Kund Badkhal Rd Faridabad Haryana 121004
Faridabad
HARYANA |
9073104356
prajjwalshahi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Non-surgical Periodontal therapy |
Non-surgical Periodontal therapy will be performed in obese subjects with and without periodontitis and non-obese subjects with periodontitis at baseline visit |
| Comparator Agent |
Salivary MMP -8 levels |
Evaluation of Salivary MMP -8 levels in obese subjects with and without periodontitis and non-obese subjects with periodontitis at one month |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Non Obese Periodontitis group
Subjects aged between 20 to 50 years
BMI less than 24.9 kg per m2
Bleeding on Probing more than equal to 10 percent
1 to 4 mm clinical attachment loss in at least 6 teeth
4 to 5 mm periodontal pocket
Subject willing to participate in study & maintain regular appointments
Obese without Periodontitis group
Subjects aged between 20 to 50 years
Obese subjects more than equal to 30 kg per m2
No clinical attachment loss
Bleeding on Probing less than 10 percent
Subject willing to participate in study & maintain regular appointments
Obese with Periodontitis group
Subjects aged between 20 to 50 years
Obese Patient more than equal 30kg per m2
1 to 4 mm clinical attachment loss in atleast 6 teeth
4 to 5 mm periodontal pocket
Bleeding on Probing more than equal to 10%
Subjects with good compliance |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
1 All forms of Tobacco users
2 Multivitamin supplements and antibiotics within the last 3 months
3 Subjects with systemic disease
4 Pregnant and lactating females.
5 Patients with history of salivary gland diseases
6 Periodontal treatment undergone in last three months
7 Subjects not willing to participate in study & maintain regular appointments |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate difference in the MMP-8 levels in obese subjects with or without periodontitis and non-obese subjects with periodontitis |
At Baseline(0) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check the change in the salivary MMP 8 levels in obese subjects with or without periodontitis & non-obese subjects with periodontitis |
at 1 month |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
14/07/2025 |
| 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="0"
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
|
The aim of the study is to evaluate salivary MMP-8 levels in obese subjects with and without periodontitis and non-obese subjects with periodontitis. The subjects as per inclusion criteria will be allocated with three groups Obese without Periodontitis group, Obese with Periodontitis group and Non Obese Periodontitis group, At the first visit (0 ) recording of salivary MMP-8 levels will be done followed by the non-surgical periodontal therapy and standardized oral hygiene instructions for all the three groups. The salivary MMP-8 levels will be recorded at 1 month and MMP-8 levels will be compared and analysed for each of groups to assess the effect of Non-surgical periodontal therapy. |