| CTRI Number |
CTRI/2024/02/063384 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
23/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of 2 methods for treatment of missing gums in between teeth. |
|
Scientific Title of Study
|
Comparative evaluation of two minimally invasive techniques for the treatment of interdental papillary reconstruction using injectable PRF and 5%Hyaluronic acid gel-A Randomized controlled clinical trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Bindu D. R. |
| Designation |
Post Graduate Student |
| Affiliation |
Dayananda Sagar College of Dental Sciences, Bangalore |
| Address |
Room 402, Department of Periodontics, Dayananda Sagar College of Dental Sciences, Shavige Malleshwara Hills, Kumarswamy Layout, Bangalore
Bangalore
KARNATAKA
560078
India |
| Phone |
8904479704 |
| Fax |
|
| Email |
bindhudr123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Archana R Naik |
| Designation |
Reader |
| Affiliation |
Dayananda Sagar College of Dental Sciences,Bangalore |
| Address |
Room 402, Department of Periodontics, Dayananda Sagar College of Dental Sciences, Shavige Malleshwara Hills, Kumarswamy Layout, Bangalore
Bangalore
KARNATAKA
560078
India |
| Phone |
9986204322 |
| Fax |
|
| Email |
archananaik@dscds.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Bindu D. R. |
| Designation |
Post Graduate Student |
| Affiliation |
Dayananda Sagar College of Dental Sciences, Bangalore |
| Address |
Room 402, Department of Periodontics, Dayananda Sagar College of Dental Sciences, Shavige Malleshwara Hills, Kumarswamy Layout, Bangalore
Bangalore
KARNATAKA
560078
India |
| Phone |
8904479704 |
| Fax |
|
| Email |
bindhudr123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self funded study, infrastuctural support provided by Dayananda Sagar College of Dental Sciences. |
|
|
Primary Sponsor
|
| Name |
Bindu DR |
| Address |
Room 402, Department of Periodontics, Dayananda sagar college of dental sciences, KS Layout, Bengaluru. |
| Type of Sponsor |
Other [self] |
|
|
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 Bindu D R |
Dayananda Sagar College of Dental Sciences, Bangalore |
Room 402, Department of Periodontics, Shavige Malleshwara Hills, Kumarswamy Layout
Bangalore
KARNATAKA |
8904479704
bindhudr123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
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 |
Injection of commercially available Hyaluronic acid gel |
Commercially available Hyaluronic acid gel will be injected using insulin syringe needle at the respective sites 2 mm apical to the coronal tip of the papilla. Similar follow up method will be carried out for test group. The procedure is repeated 2 times at 10 days interval. |
| Intervention |
Injection of i-PRF |
The patient’s blood sample is drawn in i-PRF tube and immediately centrifuged at 700 rpm for 3 minutes, in centrifugation machine. The liquid form of i- PRF is taken in insulin syringe needle and inserted at a 45 degree angle In an area 2 mm apical to interdental papilla tip and injected to respective sites 2 mm apical to the coronal tip of the papilla.The procedure is repeated 2 times at 10 days interval. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects who have agreed to be participate voluntarily.
2) Males and females in the age group of 25 - 45 years.
3) Subjects who have undergone periodontal flap surgery at least before three months.
4) Class 1 and 2 interdental papilla loss (Nordland and Tarnow 1998).
5) Subjects with history of compliance to oral hygiene instructions.
|
|
| ExclusionCriteria |
| Details |
A history of Subjects with known allergy to hyaluronic acid
Pregnant & lactating woman.
Current Smokers. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To assess the gain in papilla height after application of i-PRF in maxillary and mandibular IDP deficiencies from baseline to one month and four months.
2) To assess the gain in papilla height after application of injectable 5% Hyaluronic acid gel in maxillary and mandibular IDP deficiencies from baseline to one month and four months.
|
Outcome assesments will be made at 3 timepoints during the study period. At Baseline, 1 month and 4 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the gain in papilla height and clinical outcomes between the two groups, after application of iPRF and 5% Hyaluronic acid gel in maxillary and mandibular IDP deficiencies from baseline to one month and four months. |
one year six months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
31/03/2024 |
| 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="1"
Months="6"
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
|
The study is a Randomized Controlled Clinical Trial with parallel group study design.the study is to evaluate the efficacy of injectable PRF and 5% hyaluronic acid gel in interdental papilla reconstruction. The patients who have undergone periodontal flap surgery in the past with complaints of black triangles will be screened for the study. In the first session oral hygiene instructions will be rendered followed by thorough scaling. Clinical parameters will be recorded using a UNC-15 probe, and No 15 spreaders used for gingival thickness of interdental papillary deficiency.The occlusal stent for interdental papillary measurement will be fabricated with cold- cure clear acrylic resin on the cast model obtained from the alginate impression. The selected site will be anesthetized using topical lignocaine spray.In the test group prior to injection of i-PRF, the patient’s blood sample is drawn in i-PRF tube and immediately centrifuged at 700 rpm for 3 minutes, in centrifugation machine. The liquid form of i- PRF is taken in insulin syringe needle and inserted at a 45 degree angle in an area 2 mm apical to interdental papilla tip and injected to respective sites 2 mm apical to the coronal tip of the papilla.The procedure is repeated twice at a ten day interval. Patients will be followed for 1 and 4 months. Clinical parameters will be recorded in the above mentioned follow up time period. In the control group commercially available Hyaluronic acid gel will be injected using insulin syringe needle at the respective sites 2 mm apical to the coronal tip of the papilla. Similar follow up method will be carried out for test group. |