| CTRI Number |
CTRI/2024/02/062455 [Registered on: 08/02/2024] Trial Registered Prospectively |
| Last Modified On: |
08/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of Interdental Papillary Loss (Black Triangle) in the Manipuri Population. |
|
Scientific Title of Study
|
Effectiveness of Autologous Injectable Platelet Rich Fibrin and Hyaluronic Acid for the Treatment of Interdental Papillary Loss (Black Triangle) in the Manipuri Population. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanya Nandkeoliar |
| Designation |
Assistant Professor |
| Affiliation |
Dept of Periodontology, Dental College, RIMS |
| Address |
Room no 4, Dept of Periodontology, Dental College, Regional Institute of Medical Sciences (RIMS)
Imphal West
MANIPUR
795004
India |
| Phone |
9891725253 |
| Fax |
|
| Email |
tanya.nandkeoliar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tanya Nandkeoliar |
| Designation |
Assistant Professor |
| Affiliation |
Dept of Periodontology, Dental College, RIMS |
| Address |
Room no 4, Dept of Periodontology, Dental College, Regional Institute of Medical Sciences (RIMS)
Imphal West
MANIPUR
795004
India |
| Phone |
9891725253 |
| Fax |
|
| Email |
tanya.nandkeoliar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tanya Nandkeoliar |
| Designation |
Assistant Professor |
| Affiliation |
Dept of Periodontology, Dental College, RIMS |
| Address |
Room no 4, Dept of Periodontology, Dental College, Regional Institute of Medical Sciences (RIMS)
Imphal West
MANIPUR
795004
India |
| Phone |
9891725253 |
| Fax |
|
| Email |
tanya.nandkeoliar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical Resea5rch Unit, RIMS |
|
|
Primary Sponsor
|
| Name |
Regional Institute of Medical Sciences |
| Address |
Regional Institute of Medical Sciences (RIMS), Lamphelpat, Imphal West, Manipur- 795004 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MRU RIMS |
Medical Research Unit, Regional Institute of Medical Sciences (RIMS), Lamphelpat, Imphal West, Manipur- 795004 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tanya Nandkeoliar |
Regional Institute of Medical Sciences |
Room no 4, Dept of Periodontology, Dental College, Regional Institute of Medical Sciences (RIMS), Lamphelpat
Imphal West
MANIPUR |
9891725253
tanya.nandkeoliar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| "RESEARCH ETHICS BOARD RIMS Regional Institute of Medical Sciences Lamphelpat Imphal Manipur 795004" |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K05||Gingivitis and periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hyaluronic Acid |
Commercially available hyaluronic acid filler
Brand name- Elravie premier ultra volume L
1x1.0 ml
23 mg/ml Hyaluronic Acid
Total duration of intervention- 2 injections will be given- 1 at baseline and 1 after 3 months |
| Comparator Agent |
I-PRF |
Injectable platelet rich fibrin (autologous derivative)
procured from patient and run in centrifuge (Choukrouns duo quattro PRF centrifuge)
Total duration of intervention- 2 injections will be given- 1 at baseline and 1 after 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with interdental papilla loss with radiographic bone loss upto seven mm from apical end of contact point.
2. Teeth in proper alignment in the arch with normal contact point.
3. teeth with class two recession where the tip of interdental papilla is located between the interdental contact point and the level of the CEJ mid bucally or mid lingually - kumar and masamatti classification 2013. Interproximal bone loss is visible on the radiograph.
4. Patients with GI and PI score less than on eaafter phase one therapy. |
|
| ExclusionCriteria |
| Details |
1.Patients with missing teeth in the arch.
2.Patients who have undergone any other periodontal treatment in the anterior region in the last 6 months
3.Patients with habits associated with tobacco.
4.Patients who are pregnant, on any form of medication affecting the gingival health
5.Patients who are medically compromised
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is to check the effectiveness of autologous i- PRF with and without commercially available hyaluronic acid (HA) for the treatment of interdental papillary loss (Black Triangle). |
0 month
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To check the effectiveness of autologous i-PRF in the treatment of black triangles.
2.To assess the effectiveness of I-PRF in combination with commercially available Hyaluronic acid (HA) in the treatment of black triangles.
|
1 month
3 months
6 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 4 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Introduction The present study will be conducted to check the effectiveness of
autologous i- PRF with and without commercially available hyaluronic acid (HA)
for the treatment of interdental papillary loss (Black Triangle). Material and Methods The patients attending the Out- Patient Department of a Dental
College will be
enrolled in the study as per the inclusion and exclusion criteria. Inclusion criteria
1. 1. Patients 18 years or more with interdental
papilla loss with radiographic evidence of bone loss such that the distance
from apical end of contact point to the crest of alveolar bone is <=
7mm in the anterior region. 2. 2. Teeth in proper alignment in the arch with
normal contact point
3. 3. Teeth
with Class II Recession (Kumar and Masamatti classification, 2013)28:
The tip of the interdental papilla is located between the interdental contact
point and the level of the CEJ mid-buccally/mid-lingually. Interproximal bone
loss is visible on the radiograph. 4. Patients
with GI and PI score <1 after phase 1 therapy. Exclusion criteria 1.
Patients with missing teeth in the arch 2.
Patients who have undergone any other
periodontal treatment in the anterior region in the last 6 months 3.
Patients with habits associated with tobacco’ 4.
Patients who are pregnant, on any form of
medication affecting the gingival health
5. Patients who are medically compromised
Following this, the interdental papilla in the anterior
region will be evaluated and two areas with black triangles will be selected. Further, the two
areas selected will be divided into experimental site A and experimental site B
by the way of tossing a coin.
1.
Experimental site A- Interdental
papilla loss treated with autologous i-PRF alone.
2.
Experimental site B-
Interdental papilla loss treated with combination of i-PRF and commercially
available HA. The sites will be evaluated clinically and radiographically at 1 month, 3 months, 6 months and 9 months. The statistical analysis of the data will be done at the end of the study
T
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