| CTRI Number |
CTRI/2024/05/067181 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Measurement of Salivary Matrix  Metalloproteinease-8 Levels in stage 1 and stage 2 gums disease patients |
|
Scientific Title of Study
|
Estimation of salivary matrix metalloproteinase 8 levels in stage-1 and stage-2 periodontitis patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chennuru Sree ramya |
| Designation |
PG student |
| Affiliation |
Sibar institute of dental sciences guntur |
| Address |
Room no 8, department of periodontology,Sibar institute of dental sciences,Takellapadu, guntur.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9121799309 |
| Fax |
|
| Email |
sreeramyachennuru@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D Ravindranath |
| Designation |
Professor & HOD |
| Affiliation |
Sibar institute of dental sciences guntur |
| Address |
Room no 8, department of periodontology,Sibar institute of dental sciences,Takellapadu,guntur.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9849222259 |
| Fax |
|
| Email |
ravident69@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D Ravindranath |
| Designation |
Professor & HOD |
| Affiliation |
Sibar institute of dental sciences guntur |
| Address |
Room no 8,department of periodontology, Sibar institute of dental sciences,Takellapadu,guntur.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9849222259 |
| Fax |
|
| Email |
ravident69@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sibar institute of dental sciences,takkellapadu,guntur,Andhrapradesh,India,522509 |
|
|
Primary Sponsor
|
| Name |
Chennuru Sree ramya |
| Address |
Room no 8 ,department of periodontology,sibar institute of dental
sciences,takkellapadu,Guntur, Andhra pradesh,India,522509. |
| 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 D Ravindranath |
Sibar institute of dental sciences |
Room no,2nd floor,department of periodontology,sibar institute of dental sciences,takkellapadu, guntur 522509
Guntur
ANDHRA PRADESH |
9849222259
ravident69@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sibar institute of dental sciences |
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 |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group 20-55 years
2. Apparently healthy subjects
3. Presence of at least 20 teeth
4. Subjects with Healthy periodontium
5. Subjects with Stage â… periodontitis
6. Subjects with Stage â…¡ periodontitis
|
|
| ExclusionCriteria |
| Details |
1.H/o drug usage in last 6 months
2.Periodontal treatment in last 6 months
3.Pregnant (or) lactating women
4.Any form of tobacco use
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of salivary MMP-8 levels in stage 1 and stage 2 periodontitis individuals |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Measurement of probing depth & clinical attachment level |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
01/06/2024 |
| 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="6"
Days="6" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Periodontitis
is a multifactorial inflammatory chronic disease initiated by dysbiosis of the commensal
oral microbiota. Its pathogenesis is related to a complex interaction between
periodontal bacteria (such as Porphyromonas gingivalis, Tannerella forsythia,
Fusobacterium nucleatum, and Aggregatibacter actinomycetemcomitans) and the
host inflammatory cell-mediated immune response, and if exaggerated, this
phenomenon may lead to the deeper periodontal tissue destruction.Conventional clinical diagnostic
methods such as probing depth, bleeding on probing, attachment level, indices
and radiographs are often insufficient to determine the sites of active disease.Saliva as a mirror of oral and
systemic health is a valuable source of clinically relevant information as it
contains biomarkers that are specific to the unique physiological aspects of
periodontal diseases.Saliva contains locally and
systemically derived markers of periodontitis. Higher enzyme activities were
observed in chronic periodontitis patients than in healthy controls.During the visit of the patients to
the department, Clinical examination will be performed. Based on the inclusion
and exclusion criteria, a total of 84 patients will be selected into the study.
Out of it the sample is equally divided into 3 groups and clinical parameters
will be recorded.
Group 1: periodontally healthy
patients (n=28)
Group 2: Stage â… Periodontitis patients (n=28)
Group 3: Stage â…¡ periodontitis patients (n=28)
unstimulated saliva
sample will be collected from the patient and salivary MMP-8 levels will be
measured and compared between the groups. |