| CTRI Number |
CTRI/2022/08/044622 [Registered on: 04/08/2022] Trial Registered Prospectively |
| Last Modified On: |
14/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
The efficacy of injectable platelet rich fibrin as an adjunct to scaling and root planing in chronic periodontitis patient with type II diabetes. |
|
Scientific Title of Study
|
A Comparison of Gingival Crevicular Fluid Interleukin-6 levels with and without adjunctive Injectable Platelet Rich Fibrin after Scaling and Root Planing in Chronic Periodontitis with Type II Diabetes – A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Nivethaprashanthi |
| Designation |
Post graduate student |
| Affiliation |
Sri Venkateshwaraa Dental College |
| Address |
6th floor, OPD number 602, PG clinic, Department of Periodontology.
13A,Pondy-Villupuram main road, Ariyur, Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8248544774 |
| Fax |
|
| Email |
drnivethaswaminathan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Senthilnathan |
| Designation |
Professor and Head of the Department |
| Affiliation |
Sri Venkateshwaraa Dental College |
| Address |
6th floor, OPD number 602, PG clinic, Department of Periodontology.
13A,Pondy-Villupuram main road, Ariyur, Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9443133088 |
| Fax |
|
| Email |
principal@svdcpondy.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
S Nivethaprashanthi |
| Designation |
Post graduate student |
| Affiliation |
Sri Venkateshwaraa Dental College |
| Address |
6th floor, OPD number 602, PG clinic, Department of Periodontology.
13A,Pondy-Villupuram main road, Ariyur, Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8248544774 |
| Fax |
|
| Email |
drnivethaswaminathan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwaraa Dental College, Puducherry |
|
|
Primary Sponsor
|
| Name |
Sri Venkateshwaraa Dental College |
| Address |
13 A, Pondicherry, Villupuram Main Rd, Ariyur, 605102 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Nivethaprashanthi |
Sri Venkateshwaraa Dental College |
6th floor, OPD number 602, PG clinic, Department of Periodontology.
13A,Pondy-Villupuram main road, Ariyur, Puducherry 605102
Pondicherry
PONDICHERRY |
8248544774
drnivethaswaminathan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injectable platelet rich fibrin placed in chronic periodontitis patient with type II diabetes |
On test site scaling and root planing performed followed by Injectable platelet rich fibrin placement and on control site only scaling and root planing performed followed by saline irrigation. Later the gingival crevicular fluid interleukin-6 levels and clinical parameters were compared between the test site and control site before and after treatment. |
| Intervention |
Injectable platelet rich fibrin placed in chronic periodontitis patient with type II diabetes |
On test site Scaling and root planing performed followed by Injectable platelet rich fibrin placement and on the control site only scaling and root planing performed followed by saline irrigation. Later the gingival crevicular fluid interleukin-6 levels and clinical parameters were compared between test site and control site before and after the treatment. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Blood glucose level (HbA1c: 6.5-7.5%)
•Subjects with comparable bilateral periodontal defects associated with premolar and molar
•Clinical attachment level ≥ 3mm
•Probing Pocket Depth 4-6mm
•Plaque index score ≤ 1.9
•No history of periodontal therapy for past 6 months |
|
| ExclusionCriteria |
| Details |
•Current smokers and alcoholics
•Pregnant & lactating mothers
•Blood disorders
•Platelet count < 150000 cells/µl
•Systemic disease (other than diabetes), Medications influence on the gingival and periodontal tissues (like calcium channel blockers, or Long-term steroid use, Anticonvulsants)
•Teeth with poor periodontal prognosis.
•The teeth with poor filling and poorly fitted restorations.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in Gingival Crevicular Fluid after placement of injectable platelet rich fibrin in test site |
At baseline, 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in probing depth, Clinical attachment loss, gingival bleeding index score and plaque index score |
At baseline, 1 month, 3 months |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/08/2022 |
| Date of Study Completion (India) |
05/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
05/01/2023 |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be conducted in OPD
of Periodontology, Sri Venkateshwaraa Dental College. Subjects fulfilling the
inclusion criteria will be included in the study after obtaining written
informed consent. The sites will be randomized using computer generated
sequence. Allocation concealment by SNOSE. Both the patient and
assessor will be blinded. To avoid inter individual variation, all
interventions will be done by the same operator and the outcome will be
evaluated by the same assessor. Subgingival scaling and root
planing will be done in both control and experimental site followed by placement
of Injectable Platelet Rich Fibrin only in test site using blunt cannula. Periodontal pack will be
given on both the sites followed by postoperative instructions. Interleukin-6
levels will be assessed at baseline and 1 month. Clinical
parameters will be assessed at baseline, 1 month and 3months. |