| CTRI Number |
CTRI/2021/06/034280 [Registered on: 17/06/2021] Trial Registered Prospectively |
| Last Modified On: |
06/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
application of growth factors after deep cleaning in the type 2 diabetes mellitus patient having gum disease. |
|
Scientific Title of Study
|
Clinical evaluation of the combined efficacy of scaling and root planing (SRP) and injectable platelet rich fibrin (i-PRF) in the non-surgical periodontal therapy of Stage III and Grade C periodontitis patients having Type 2 Diabetes mellitus.
-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 |
Shunmuga Prasanth D |
| Designation |
Post graduate |
| Affiliation |
SRM dental college |
| Address |
Department of Periodontology and oral implantology
PG section
Block 1,4th floor
SRM dental college
Bharati salai,ramapuram
Chennai.
Chennai
TAMIL NADU
600089
India |
| Phone |
09003208920 |
| Fax |
|
| Email |
prasanthalur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupama Tadepalli |
| Designation |
Reader |
| Affiliation |
SRM dental college |
| Address |
Department of Periodontology and oral implantology
Reader
PG section
Block 1,4th floor
SRM dental college
Bharati salai,ramapuram
Chennai.
Chennai
TAMIL NADU
600089
India |
| Phone |
9677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shunmuga Prasanth D |
| Designation |
Post graduate |
| Affiliation |
SRM dental college |
| Address |
Department of Periodontology and oral implantology
PG section
Block 1,4th floor
SRM dental college
Bharati salai,ramapuram
Chennai.
Chennai
TAMIL NADU
600089
India |
| Phone |
09003208920 |
| Fax |
|
| Email |
prasanthalur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shunmuga Prasanth D
SRM DENTAL COLLEGE,BHARATHI SALAI
RAMAPURAM,CHENNAI-600089 |
|
|
Primary Sponsor
|
| Name |
Shunmuga Prasanth D |
| Address |
52/46,Star Appartments,Janaki Gardens,Panchayat Road,Golden George Nagar,Mogappair,Chennai |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Shunmuga Prasanth |
SRM dental College |
Department of Periodontology and oral implantology
PG section
Block 1,4th floor
SRM dental college
Bharati salai,ramapuram
Chennai.
Chennai
TAMIL NADU |
9003208920
prasanthalur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD,SRM DENTAL COLLEGE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
i-PRF |
Scaling and Root planing + i-PRF |
| Comparator Agent |
Saline |
Scaling and Root planing + Saline |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Type 2 Diabetes mellitus subjects with the glycaemic status having HbA1c ≥ 7
2.Subjects on oral medication for the management of Diabetes mellitus.
3.Subject with moderate periodontal disease with the case definition, StageIII and Grade C periodontitis, according to EFP-AAP periodontal disease classification 2017. i.e., Moderate periodontal destruction is defined as sites having ≥ 5mm probing pocket depth with attachment loss.
4.Moderate periodontal destruction at least, in 2 interproximal sites in each mandibular quadrant.
5.Minimum presence of 4 permanent teeth per mandibular quadrant (excluding 3rd molars).
|
|
| ExclusionCriteria |
| Details |
1.Sites with pseudo pockets / advanced periodontal destruction with mobility and Grade IV furcation involvement
2.Periodontal therapy within last 6 months
3.Previous history of intake of antibiotics over last 6 months
4.Systemic condition / disease other than Type II DM, having influence on course and treatment outcomes of periodontal disease.
5.Screening for the infectious disease will be done and the subjects with infectious diseases will be excluded.
6.Individuals with known platelet disorders
7.Smokers
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the changes in the:
Clinical attachment level (CAL)
before and after therapy within and between the groups. |
Baseline
3Months
6Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the changes in the
1.Probing pocket depth (PPD)
2.Plaque index (PI)
3.Sulcular Bleeding Index (SBI)
before and after therapy within and between the groups. |
Baseline
3Months
6Months |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="23" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/06/2021 |
| Date of Study Completion (India) |
18/10/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Subjects with Diabetes mellitus are prone to have more periodontal destruction than when compared to healthy individuals. uncontrolled Diabetes mellitus subjects respond poorly to the nonsurgical periodontal therapy alone in management of periodontal pockets. Hence, in this study we would like be clinically evaluate the adjunctive benefits of injectable platelet rich fibrin (i-PRF) along with scaling and root planing in periodontitis subjects with type 2 Diabetes mellitus(HbA1c>7). |