| CTRI Number |
CTRI/2019/01/017043 [Registered on: 11/01/2019] Trial Registered Prospectively |
| Last Modified On: |
08/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Measuring bone growth in bony defects caused by periodontal diseases after treating with growth factors found in blood along with artificial bone powder. |
|
Scientific Title of Study
|
Comparative evaluation of concentrated growth factor and bioactive glass in the treatment of furcation defects:A clinical and radiographic study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thaslim Fathima N |
| Designation |
Postgraduate student |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Rajarajeswari Dental College and Hospital
No.14, Ramohalli cross, Mysore road,Kumbalgodu
Bangalore
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
9620094215 |
| Fax |
|
| Email |
thaslimfathima93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Senthil Rajan |
| Designation |
Reader |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Rajarajeswari Dental College and Hospital
No.14, Ramohalli cross, Mysore road,Kumbalgodu
Bangalore
Rajarajeswari Dental College and Hospital
No.14, Ramohalli cross, Mysore road,Kumbalgodu
Bangalore
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
9036943516 |
| Fax |
|
| Email |
senthilrajanrs21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Thaslim Fathima N |
| Designation |
Postgraduate student |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Rajarajeswari Dental College and Hospital
No.14, Ramohalli cross, Mysore road,Kumbalgodu
Bangalore
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
9620094215 |
| Fax |
|
| Email |
thaslimfathima93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Thaslim Fathima N
Rajarajeswari Dental College and Hospital
No.14, Ramohalli cross, Mysore road,Kumbalgodu
Bangalore-560074
|
|
|
Primary Sponsor
|
| Name |
Rajarajeswari Dental College and Hospital |
| Address |
Rajarajeswari Dental College and Hospital
No.14, Ramohalli cross, Mysore road,Kumbalgodu
Bangalore-560072
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Thaslim Fathima N |
Rajarajeswari Dental College and Hospital |
Department of Periodontology
Room No. 4
Rajarajeswari Dental College and Hospital
No.14, Ramohalli cross, Mysore road,Kumbalgodu
Bangalore-560074
Bangalore Rural
KARNATAKA |
9620094215
thaslimfathima93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeswari Dental College and Hospital |
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 |
CGF- concentrated growth factor |
10 ml intravenous blood without anticoagulant is collected and placed in centrifuge tubes and accelerated for 30 s, centrifuged at 2700 rpm for 2 min, 2400 rpm for 4 min, 2700 rpm for 4 min, and 3000 rpm for 3 min, and decelerated for 36 s to stop. The CGF clot obtained will be immediately placed in the furcation defect. |
| Comparator Agent |
Open flap debridement |
Kirkland flap surgery with debridement. |
| Intervention |
PerioGlas- bioactive glass particulate |
PerioGlas is mixed with the CGF and placed in the furcation defects. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Presence of Grade II furcation defects (Glickman’s classification) in mandibular molars, with a radiolucency in the furcation area, with a probing depth (PD) ≥5mm and horizontal PD ≥3mm. |
|
| ExclusionCriteria |
| Details |
1.Patients with systemic illness known to affect the outcomes of periodontal therapy.
2.Patients on any medication taken within the last 6 months which may alter the periodontal status.
3.Individuals allergic to medications.
4.Pregnant or lactating women.
5.Chronic smokers and alcoholics
|
|
|
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 |
1.Horizontal measurement of the furcation defect
2.Vertical probing depth
3.Radiographic defect depth |
Baseline
6 months
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gingival index
Plaque index
Gingival marginal level
Clinical attachment level |
Baseline
6 months
9 months |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2019 |
| 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="0"
Months="9"
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)?
|
|
Brief Summary
|
Concentrated growth factors (CGFs) are a new generation of platelet concentrates, which contain abundant growth factors. CGF is produced by the centrifugation of venous blood, and platelets are concentrated in a gel layer containing ï¬brin matrix as same as Platelet-Rich-Fibrin (PRF). However, a different centrifugation speed permits the isolation of much larger, denser and richer Growth Factors (GFs) in ï¬brin matrix from CGF. This ï¬brin clot has a high cohesion because of the agglutination of ï¬brinogen, factor XIII and thrombin. This provides protection from plasmin degradation, resulting in higher ï¬brin tensile strength and stability. This study aims at evaluating and comparing the efficacy and regenerative potential of CGF and CGF in combination with bioactive glass in the treatment of furcation defects. 36 molar furcation defects in patients with chronic periodontitis will be grouped into 3 categories. Following administration of LA, a full thickness flap will be reflected and granulation tissue will be removed. Following debridement, the furcation defect will be filled using appropriate graft material. Group I patients will receive CGF. Group II patients will receive CGF mixed with bioactive glass. Group III patients will undergo an open flap debridement only. Clinical and radiological parameters will be recorded at baseline, 6 months and 9 months post-operatively. |