| CTRI Number |
CTRI/2022/09/045964 [Registered on: 27/09/2022] Trial Registered Prospectively |
| Last Modified On: |
26/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Efficacy of Gingival Application of Injectable Platelet Concentrate and Green Tea Gel as an Add-On in the treatment of Periodontitis |
|
Scientific Title of Study
|
Comparative Efficacy of Local Subgingival Application of Injectable Platelet Rich Fibrin and (-)-Epigallocatechin Gallate Gel as an Adjunct to Scaling and Root Planing: A Randomized Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyadarshika Kumari |
| Designation |
Post Graduate Student |
| Affiliation |
Vydehi Institute of Dental Sciences and Research Centre, Bangalore |
| Address |
Department of Periodontics
Vydehi Institute of Dental Sciences and Research Centre
# 82, EPIP Area,
Whitefield, Bangalore- 560066 Karnataka, India
Bangalore
KARNATAKA
560066
India |
| Phone |
09986980468 |
| Fax |
|
| Email |
30priyadarshika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeela Guru |
| Designation |
Reader |
| Affiliation |
Vydehi Institute of Dental Sciences and Research Centre, Bangalore |
| Address |
Department of Periodontics
Vydehi Institute of Dental Sciences and Research Centre
# 82, EPIP Area,
Whitefield, Bangalore- 560066 Karnataka, India
No. 11, 1st Cross, Chennakeshava Layout, K. K Halli, Bangalore- 560084
Bangalore
KARNATAKA
560066
India |
| Phone |
07259665551 |
| Fax |
|
| Email |
sanjeelaguru@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeela Guru |
| Designation |
Reader |
| Affiliation |
Vydehi Institute of Dental Sciences and Research Centre, Bangalore |
| Address |
Department of Periodontics
Vydehi Institute of Dental Sciences and Research Centre
# 82, EPIP Area,
Whitefield, Bangalore- 560066 Karnataka, India
No. 11, 1st Cross, Chennakeshava Layout, K. K Halli, Bangalore- 560084
Koppal
KARNATAKA
560066
India |
| Phone |
07259665551 |
| Fax |
|
| Email |
sanjeelaguru@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Vydehi Institute of Dental Sciences and Research Centre, Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr Priyadarshika Kumari |
| Address |
Department of Periodontics
Vydehi Institute of Dental Sciences and Research Centre, #82, EPIP Area, Whitefield, Bangalore- 560066 |
| 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 |
| Dr Priyadarshika Kumari |
Room no- 6, 2nd floor, Department of Periodontics |
Vydehi Institute of Dental Sciences and Research Centre
# 82, EPIP Area,
Whitefield, Bangalore- 560066 Karnataka, India
Bangalore
KARNATAKA |
9986980468
30priyadarshika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vydehi Institute of Dental Sciences- Institutional Ethics Committee (VIDS-IEC) |
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 |
| Comparator Agent |
Scaling and Root Planing |
Scaling and Root Planing |
| Intervention |
Topical subgingival application of (-)-epigallocatechin gallate (EGCG) gel |
Scaling and Root Planing followed by topical subgingival application of (-)-epigallocatechin gallate (EGCG) gel.
EGCG gel form of (-)-epigallocatechin gallate to be stored in container masked and tightened with cap to avoid light and oxygen interference.
Route of administration :-EGCG gel will be filled in 1 ml syringe with 23 gauze blunt tip needle.
Content of gel preparation
EGCG- 10%
Poloxamer 188- 30%
Glycerine- 10 %
Sodium benzoate- 0.1%
Distilled water, quantity sufficient- 100%
dose- 1 ml, duration of therapy and intervention- 6 months
|
| Intervention |
Topical subgingival application of injectable platelet-rich fibrin (I-PRF) |
Scaling and Root Planing followed by topical subgingival application of injectable platelet-rich fibrin (I-PRF)
Preparation of I-PRF
Blood sample to be collected in 10 ml tube. Whole blood without anticoagulant will be centrifuged at 700 RPM for 3 min at room temperature. Supernatant liquid layer will be collected as I-PRF using syringe.
Route of administration:- I-PRF will be applied into periodontal pocket through perforation at point of interdental space on individually formed occlusal splint which was enabled to hold it for longer time. Splint will be removed after 15 mins.
Dose- 1ml,
Duration of therapy/ intervention- 6 months
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients within the age of 35 to 60 years
2. Presence of minimum of 16 natural teeth excluding 3rd molars
3. Systemically healthy patients with periodontitis (Stage II, III) clinically diagnosed based on 2017 World Workshop on the Classification of Periodontal and Peri- implant diseases and conditions.[12] Periodontitis patients with Bleeding on probing ≥ 40% of teeth, clinical attachment loss ≥ 3mm in more than 30% of the sites and probing pocket depth ≥5 mm with at least 6 teeth and radiographic bone loss ranging from coronal to middle third or beyond.
|
|
| ExclusionCriteria |
| Details |
1. Patients with any systemic diseases
2. Patients with allergy to green tea or product of green tea.
3. Patients with history of periodontal therapy within past 6 months
4. Patients with history of antibiotic intake within past 3 months
5. Patients with history of anti-inflammatory drug therapy within 3 months
6. Furcation involvement
7. Pregnancy or lactation
8. Current or former smokers
9. Patients with any intra oral lesions
|
|
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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 |
Clinical Attachment level (CAL)
Gingival Margin Level(GML)
Probing Pocket depth(PPD)
|
At baseline,
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Bleeding on Probing(BOP)
Plaque Index(PI)
|
At baseline
3 months
6 months |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of the study
Aim of this study is to evaluate the
clinical efficacy of local subgingival application of i-prf and EGCG gel as adjunct to SRP on periodontal clinical parameters of stage II & III periodontitis patients
as compared to SRP alone.
Material and methods:
Study design: Randomized controlled clinical trial
Clinical protocol:
1. Informed consent to be obtained from the patients who wish to participate in the study
2. Demographic characteristics such as age, sex, and medical history to be recorded
3. Clinical parameters will be recorded at baseline, 3 months and 6 months. The following clinical parameters will be evaluated:
i.
Plaque index (PII) by Silness and Loe 1964
ii.
Percentage of bleeding sites (Dichotomous
scoring)
iii.
Probing pocket depth (PPD)- measured at six sites per tooth using UNC 15 periodontal probe
,iv. Clinical attachment level (CAL)- measured at six sites per tooth using UNC 15 periodontal probe and occlusal splint
v.
Gingival Margin Level (GML)- measured from CEJ to crest of marginal gingiva
The data obtained will be
statistically analysed
|