| CTRI Number |
CTRI/2021/02/031359 [Registered on: 17/02/2021] Trial Registered Prospectively |
| Last Modified On: |
16/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To find out the effect of bone like material mixed with material obtained from patients own blood in gum diseases with evenly reduced bone height. |
|
Scientific Title of Study
|
Evaluation of the Efficacy of Calcium Phosphosilicate Bioactive Glass in Combination with Autologous Platelet Rich Fibrin in the Treatment of Horizontal Bone Defects in Periodontitis- Randomized controlled trial with split mouth design |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swathy S |
| Designation |
Post Graduate |
| Affiliation |
Rajiv Gandhi University of Health Sciences, Karnataka |
| Address |
Vydehi Institute of Dental Sciences and Research Center, EPIP Area, Nallurhalli, Whitefield, Bangalore
Vydehi Institute of Dental Sciences and Research Center, 82, EPIP Area, Nallurhalli, Whitefield, Bangalore
Bangalore
KARNATAKA
560066
India |
| Phone |
9946053866 |
| Fax |
|
| Email |
swathyskumar91@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha K J |
| Designation |
Professor and Head |
| Affiliation |
VYDEHI INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of Periodontics, Vydehi institute of Dental sciences and Research center, EPIP Area, Nallurhalli, Whitefield
82, EPIP Area, Nallurhalli, Whitefield, Bangalore
Bangalore
KARNATAKA
560066
India |
| Phone |
8105490909 |
| Fax |
|
| Email |
nisharejath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swathy S |
| Designation |
Post Graduate |
| Affiliation |
Rajiv Gandhi University of Health Sciences, Karnataka |
| Address |
Department of Periodontics, Vydehi institute of Dental Sciences and Research Centre,82, EPIP area, Nallurhalli,Whitefield, Bangalore
Vydehi institute of Dental Sciences and Research center,82 EPIP AREA,NALLURAHALLI, WHITEFIELD,BANGALORE-560066
Bangalore
KARNATAKA
560066
India |
| Phone |
9946053866 |
| Fax |
|
| Email |
swathyskumar91@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Vydehi Institute of Dental Sciences and Research Centre,82, EPIP Area, Nallurhalli, Whitefield, Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr Swathy S |
| Address |
Vydehi Institute of Dental Sciences,82, EPIP area, Nallurhalli, Whitefield, Bangalore |
| Type of Sponsor |
Other [INDIVIDUAL] |
|
|
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 Swathy S |
Vydehi Institute of Dental Sciences and Research center |
Department of Periodontics, 82, EPIP Area, Nallurhalli, Whitefield, Bangalore
Bangalore
KARNATAKA |
9946053866
swathyskumar91@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vydehi Institute of Dental Sciences and Research Center Ethics 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 |
Periodontal Flap Surgery |
Open Flap Debridement |
| Comparator Agent |
regenerative periodontal therapy |
calcium phosphosilicate bioactive glass mixed with autologous platelet rich fibrin covered by PRF membrane |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with stage II and III periodontitis according to 2017 World Workshop on the Classification of Periodontal and Peri-implant diseases and conditions
Premolars and molars with a probing depth of ≥ 5mm to 8mm and a horizontal bone loss of 5mm or more from the CEJ to the alveolar crest in CBCT
|
|
| ExclusionCriteria |
| Details |
Medically compromised patients
Teeth with grade III mobility
Patients who underwent periodontal surgery in the past one year
Smokers
Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Probing pocket depth
Clinical attachment level
Height of bone assessed from CEJ to the alveolar crest obtained through Cone Beam Computed Tomography radiographic method
Width of the bone at the thinnest portion between the buccal / lingual and palatal plate in axial tomogram
|
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Plaque index
Gingival index
|
9 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
23/02/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study titled evaluation of the efficacy of calcium phosphosilicate bioactive glass in combination with autologous platelet rich fibrin in the treatment of horizontal bone defects in periodontitis will be conducted in Vydehi Institute of Dental Sciences and Research Centre for a study period of 9 months. Periodontitis is a chronic inflammatory disease that causes loss of tooth attachment apparatus. one of the prominent signs of destructive periodontal disease is loss of alveolar bone support. In this loss of alveolar bone support horizontal bone loss is the most prominent. though the prevelance of horizontal bone loss is 92%, the available treatment modalities are only 2%. Thus the main aim of my study is evaluate the effect calcium phsphosilicate bioactive glass in combination with autologous platelet rich fibrin in the treatment of horizontal bone loss. |