| CTRI Number |
CTRI/2024/10/075526 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of Titanium Platelet Rich Fibrin (T-PRF) and collagen membrane in conjunction with synthetic bone graft in the treatment of intrabony periodontal defects: A Clinico radiographic study |
|
Scientific Title of Study
|
Comparative evaluation of Titanium platelet rich fibrin (T-PRF) and xenogenic collagen membrane in conjunction with synthetic bioactive calcium phosphosilicate bone graft in the treatment of intrabony periodontal defects- A clinico radiographic study |
| 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 Lekshmi R |
| Designation |
Postgraduate student |
| Affiliation |
Rajarajeswari dental college and hospital |
| Address |
Room No.4, Department of Periodontology, Rajarajeswari Dental
College and Hospital, No.14, Ramohalli cross, Mysore road,
Kumbalgodu, Bengaluru, 560074, KARNATAKA
India
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
7012613356 |
| Fax |
|
| Email |
lekshmiratheevijayan95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KRISHNA KRIPAL |
| Designation |
Professor |
| Affiliation |
Rajarajeswari dental college and hospital |
| Address |
Room No.4, Department of Periodontology, Rajarajeswari Dental
College and Hospital, No.14, Ramohalli cross, Mysore road,
Kumbalgodu, Bengaluru, 560074, KARNATAKA
India
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
9632597504 |
| Fax |
|
| Email |
kripalkrishna@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KRISHNA KRIPAL |
| Designation |
Professor |
| Affiliation |
Rajarajeswari dental college and hospital |
| Address |
Room No.4, Department of Periodontology, Rajarajeswari Dental
College and Hospital, No.14, Ramohalli cross, Mysore road,
Kumbalgodu, Bengaluru, 560074, KARNATAKA
India
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
9632597504 |
| Fax |
|
| Email |
kripalkrishna@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari dental college and hospital Room No.4, Department of Periodontology,
Rajarajeswari Dental College and Hospital, No.14, Ramohalli cross, Mysore road, Kumbalgodu,
Bengaluru, 560074, KARNATAKA |
|
|
Primary Sponsor
|
| Name |
Dr Lekshmi R |
| Address |
Room No.4, Department of Periodontology, Rajarajeswari Dental
College and Hospital, No.14, Ramohalli cross, Mysore road,
Kumbalgodu, Bengaluru, 560074, KARNATAKA |
| 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 Lekshmi R |
Rajarajeswari dental college and hospital |
Room No.4,
Department of
Periodontology,
Rajarajeswari Dental
College and Hospital,
No.14, Ramohalli cross,
Mysore road,
Kumbalgodu,
Bengaluru, 560074,
KARNATAKA
Bangalore
KARNATAKA
Bangalore Rural
KARNATAKA |
7012613356
lekshmiratheevijayan95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeswari dental college and hospital institutional ethical committee |
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 |
| Intervention |
T-PRF Membrane |
Full thickness mucoperiosteal flap will be raised followed by placement of T-PRF membrane and bioactive calcium phosphosilicate bonegraft(Novabone putty and Novabone Morsels) and sutured for intrabony defects ≥ 3mm at baseline |
| Comparator Agent |
Xenogenic collagen membrane (Synerheal Fix Guide GTR membrane) |
Full thickness mucoperiosteal flap will be raised followed by placement of xenogenic collagen membrane ((Synerheal Fix Guide GTR membrane) and bioactive calcium phosphosilicate bonegraft(Novabone putty and Novabone Morsels) and sutured for intrabony defects ≥ 3mm at baseline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with generalised chronic periodontitis.
Patients willing to take part in the study.
Systemically healthy patients.
Presence of 2-3 wall intrabony defects with ≥ 3mm (the distance between the alveolar crest and base of defect) on intraoral periapical radiograph [IOPA] along with interproximal probing depth[PD] ≥ 5mm after phase 1 therapy.
Patients with no history of allergy to materials and drugs used or prescribed in this study.
|
|
| ExclusionCriteria |
| Details |
Patients who have undergone periodontal treatment within a period of 1 year.
Patients on any medication taken within the last 6 months which may alter the periodontal status.
Chronic smokers and alcoholics.
Pregnant and lactating females
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To clinically evaluate Probing Pocket depth (PPD),Clinical attachment level (CAL),Thickness of attached gingiva and radiographically (IOPAR or RVG) to evaluate and to measure the intrabony defect (the distance between the alveolar crest and base of defect)
|
at baseline and after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate clinically and radiographically the regenerative potential of T-PRF and xenogenic collagen membrane in conjunction with bioactive calcium phosphosilicate bonegraft (Novabone putty and Novabone Morsels) in the treatment of periodontal intrabony defects. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
07/11/2024 |
| 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="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
|
This study aims to clinically and radiographically evaluate the efficacy of T-PRF and xenogenic collagen membrane (Synerheal Fix Guide GTR membrane) in conjunction with bioactive calcium phosphosilicate bonegraft (Novabone putty and Novabone Morsels) in the treatment of periodontal intrabony defects.
The study is not yet started. |