| CTRI Number |
CTRI/2024/06/069189 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparative Evaluation of Salivary Macrophage Inflammatory Protein-1α (MIP-1α) Levels in Periodontitis Patients Following Photo-Biomodulation Combined with Non-Surgical Periodontal Therapy vs. Non-Surgical Periodontal Therapy Alone |
|
Scientific Title of Study
|
Comparative evaluation of salivary macrophage inflammatory protein -1α (MIP-1α) levels in periodontitis subjects post photo-biomodulation combined with non-surgical periodontal therapy and non-surgical periodontal therapy alone: A prospective interventional 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 |
Fazal Mujawar |
| Designation |
2nd MDS |
| Affiliation |
School of dental sciences, KVV, karad |
| Address |
Department of periodontology, ground floor, School of Dental Sciences, KVV, karad, maharashtra
School of Dental Sciences
Kolhapur
MAHARASHTRA
415539
India |
| Phone |
09527181511 |
| Fax |
|
| Email |
fazalmujawar1511@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sameer Zope |
| Designation |
reader |
| Affiliation |
School of dental sciences, KVV, karad |
| Address |
Dept. no. 2,Department of peridontology, ground floor, School of Dental Sciences, KVV, karad, maharashtra
School of Dental Sciences
Kolhapur
MAHARASHTRA
415539
India |
| Phone |
09527181511 |
| Fax |
|
| Email |
aoldentist@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Fazal Mujawar |
| Designation |
2nd MDS |
| Affiliation |
School of dental sciences, KVV, karad |
| Address |
Department of periodontology, ground floor, School of Dental Sciences, KVV, karad, maharashtra
School of Dental Sciences
Kolhapur
MAHARASHTRA
415539
India |
| Phone |
09527181511 |
| Fax |
|
| Email |
fazalmujawar1511@gmail.com |
|
|
Source of Monetary or Material Support
|
| Krishna Vishwa Vidyapeeth, Karad, Malkapur, Maharashtra, 415539 |
|
|
Primary Sponsor
|
| Name |
School of dental scinces, krishna vishwa vidyapeeth, karad |
| Address |
krishna vishwa vidapeeth, karad, malkapur, maharashtra, 415539 |
| 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 Fazal Mujawar |
School of Dental Sciences, |
Department of peridontology, ground floor, School of Dental Sciences, Krishna Vishwa Vidyapeeth, Karad, 415539
Satara
MAHARASHTRA |
9527181511
fazalmujawar1511@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: K053||Chronic periodontitis, (2) ICD-10 Condition: Z008||Encounter for other general examination, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Non-surgical periodontal therapy (NSPT) |
patients in Group-1 will under go thorough (NSPT) Scaling and root planning and oral hygiene instructions. the sample will be collected at baseline and post 21 days, so the total duration of intervention is 21 days. |
| Comparator Agent |
NSPT with laser photobiomodulation |
patients in group 2 will undergo NSPT along with diode laser photobiomodulation in a single visit. the samples will be collected at baseline and post 21 days, all the procedures will be collected at first appointment only |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
systemically healthy patients with stage 2 and grade B of generalized periodontitis, between age of 30 to 60 years |
|
| ExclusionCriteria |
| Details |
pregnant, lactating females, on antibiotic therapy or who has a previous history of peridontitis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in periodontal health and biochemical parameters |
the clinical parameters and biochemical parameters, will be assessed at baseline and post 21 days in both the groups using abbkine CCL3
kit with ELISA reader for bio-chemical analysis, and using plaque index, gingival index, calculus index, Pocket probing depth and clinical attachment loss, at both baseline and post 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Pocket probing depth, Clinical attachment loss, Gingival index, Plaque index |
post 21 days of intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/06/2024 |
| 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="0"
Months="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
participants with stage 2 and grade B periodontitis are identified and will be enrolled in the study, the participants distributed in 2 groups, one group with 30 participants will receive non-surgical periodontal therapy alone and the 2nd group will receive Non-surgical periodontal therapy with photobiomodulation with diode laser. all clinical parameters along with Salivary MIP-1 alpha levels will be assessed at the base line and post 21 days of intervention. |