| CTRI Number |
CTRI/2025/07/090868 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of scaling on ghrelin and Tumor necrosis factor -alpha molecules levels in gingival crevicular fluid of healthy individuals and chronic generalised periodontitis with and without Type 2 diabetes mellitus |
|
Scientific Title of Study
|
EFFECT OF NON SURGICAL PERIODONTAL THERAPY ON GHRELIN AND TUMOR NECROSIS FACTOR -ALPHA (TNF-a) IN GINGIVAL CERVICULAR FLUID OF HEALTH AND CHROINC GENERALISED PERIODONTITIS WITH AND WITHOUT TYPE 2 DIABETES MELLITUS -A - CLINICO-BIOCHEMICAL 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 |
Kaustubh Ram |
| Designation |
3rd year MDS in Periodntology |
| Affiliation |
The Oxford Dental College, Bangalore |
| Address |
Room No 3 , Department of Periodontology , The Oxford dental college , Bangalore,
Bangalore
KARNATAKA
560068
India |
| Phone |
9916557585 |
| Fax |
|
| Email |
kaustubhram007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savitha A N |
| Designation |
3rd year MDS in Periodntology |
| Affiliation |
The Oxford Dental College, Bangalore |
| Address |
Room no 3 , Department of periodontology, The oxford dental college, Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
9845203336 |
| Fax |
|
| Email |
sunaina1096@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kaustubh Ram |
| Designation |
3rd year MDS in Periodntology |
| Affiliation |
The Oxford Dental College, Bangalore |
| Address |
Room No 3 , Department of periodontology , The Oxford dental college , Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
9916557585 |
| Fax |
|
| Email |
kaustubhram007@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Oxford Dental college Bangalore 560068 |
|
|
Primary Sponsor
|
| Name |
Kaustubh Ram |
| Address |
No.943 Next To Weavers Street School D K Main Road ,Doddaballapur, Bangalore, karnataka, India 561203 |
| Type of Sponsor |
Other [Self sponcers] |
|
|
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 M B Kaustubh Ram |
The oxford dental college |
Room No. 3 Dept of periodontology, 2nd floor , The oxford dental college , Bommanahalli, Bangalore 560068
Bangalore
KARNATAKA |
9916557585
kaustubhram007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, (2) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Non Surgical periodntal Therapy
(Scaling ) |
NSPT will be done using piezoelectric ultrasonic scalers an all the study participants in Group 1 (healthy) for 4 weeks |
| Intervention |
Non Surgical Periodontal Therapy(NSPT) |
NSPT will be done using piezoelectric ultrasonic scalers on Participants in Group 2(Periodontitis) for 4 weeks |
| Intervention |
Non surgical Periodontal Therapy(NSPT) |
NSPT will be done using piezoelectric ultrasonic scalers on Participants in Group 3(Periodontitis with Type 2 Diabeties) for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.age between 20 to 60
2.indivigual in which there is presence of at least 20 natural teeth
3.patients with Stage III grade B periodontitis.
4.Patients with healthy periodontium
5.sumjects with controlled T2DM
6. Subjects without T2DM |
|
| ExclusionCriteria |
| Details |
1.individuals with other systemic disease other than controlled T2DM
2.Individuals who have received periodontal therapy in the last 6 months.
3.smokers
4.Pregnant/lactating mothers
5.individuals who had antimicrobial and Anti-inflammatory therapy in last 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| levels of Ghrelin and TNF- alpha in GCF after NSPT |
baseline and end of 3 months after NSPT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque index , Gingival Index Bleeding on probing Probing Depth and clinical attachment loss |
baseline and end of 3 months after NSPT |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 |
|
Date of First Enrollment (India)
|
31/07/2025 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Periodontitis is a chronic inflammatory disease that leads to irreversible damage and tooth loss. Ghrelin a peptide hormone , plays a key role in periodontal health by modulating inflammatory responses. TNF-alpha , a pro inflammatory cytokine, contribute to insulin resistance and T2DM. Reduced expression of ghrelin receptors in periodntal tissue may enhance TNF-alpha activity, leading to inflammation. This study mains to estimate and compare ghrelin and TNF alpha levels in GCF before and after NSPT in healthy, periodontitis with and without T2DM individuals. the objective of the study is to estimate the ghrelin and TNF- alpha in healthy , periodontitis with and without T2DM individuals before and after NSPT and to assess the potential of ghrelin as an inflammatory markers in period0ntitis |