| CTRI Number |
CTRI/2022/09/046028 [Registered on: 29/09/2022] Trial Registered Prospectively |
| Last Modified On: |
29/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison b/w efficiency of bone graft derived from animals with advanced human blood clot & bone graft derived from animals with liquified human blood clot in the treatment of bony defects in chronic gum disease |
|
Scientific Title of Study
|
Comparative Clinical and Radiographic Evaluation of the Efficacy of Bovine
Derived Xenograft (Fix-Oss â„¢) with Advanced Platelet Rich Fibrin Plus (A-PRF
plus) and Bovine Derived Xenograft (Fix-Ossâ„¢) with Injectable Platelet Rich
Fibrin (i-PRF) Used in the Treatment of Intrabony Defects in Chronic
Periodontitis Patients- A Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayati Pandit |
| Designation |
First year Postgraduate MDS, Department of Periodontics |
| Affiliation |
Nair hospital Dental College,Mumbai |
| Address |
Room no 201, Department of Periodontics, Nair Hospital Dental College,Mumbai,Maharashtra, 400008 India
Mumbai
MAHARASHTRA
400008
India |
| Phone |
08446022798 |
| Fax |
|
| Email |
jayatipandit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mala Dixit Baburaj |
| Designation |
Professor and Head of the Department |
| Affiliation |
Nair hospital Dental College,Mumbai |
| Address |
Room no 201, Department of Periodontics, Nair Hospital Dental College,Mumbai,Maharashtra, 400008 India
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9223340938 |
| Fax |
|
| Email |
maladixit25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mala Dixit Baburaj |
| Designation |
Professor and Head of the Department |
| Affiliation |
Nair hospital Dental College,Mumbai |
| Address |
Room no 201, Department of Periodontics, Nair Hospital Dental College,Mumbai,Maharashtra, 400008 India
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9223340938 |
| Fax |
|
| Email |
maladixit25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Jayati Pandiy,Room no 201, Department of Periodontics,Nair Hospital Dental College, Mumbai,Maharashtra,400008,India |
|
|
Primary Sponsor
|
| Name |
Dr Jayati Pandit |
| Address |
Room no 201, Department of Periodontics,Nair Hospital Dental College,Mumbai, Maharashtra,400008,India |
| Type of Sponsor |
Other [First year postgraduate student] |
|
|
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 Jayati Pandit |
Nair Hospital Dental College |
Room no 201,Department of Periodontics,Naiir Hospital Dental college, Mumbai,Maharashtra,400008
Mumbai
MAHARASHTRA |
7620865570
jayatipandit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Nair Hospital Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bovine Derived Xenograft with Advanced Platelet Rich Fibrin Plus |
Bovine Derived Xenograft (Fix-Oss) with Advanced Platelet Rich Fibrin Plus |
| Intervention |
Bovine Derived Xenograft with Injectable Platelet Rich Fibrin (i-PRF) |
Bovine Derived Xenograft (Fix-Oss) with Injectable Platelet Rich Fibrin (i-PRF) |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients in the age group between 30-60 yrs.
2)patients diagnosed with Chronic Periodontitis.
3)Patients who are non smokers or do not consume tobacco in any other form.
4)Patients are in good systemic health with no contraindication to periodontal
surgery.
5) Patients having pocket depths >5mm, intraosseous defects > 3mm and with
radiographic evidence of vertical / angular bone loss in the affected sites.
6) Involved teeth to be vital and asymptomatic. |
|
| ExclusionCriteria |
| Details |
1) One-walled osseous defects.
2) Patients suffering from any systemic diseases or with a compromised
immune system.
3) Patients who had received any type of periodontal therapy for the past 6
months.
4) Patients taking immunosuppressant drugs like corticosteroids.
5) Patients with a known history of allergy to Doxycycline or Chlorhexidine or
any other medicine used in the study.
6) Patients showing unacceptable oral hygiene compliance during / after Phase
I periodontal therapy.
7) Patients taking any drug known to cause gingival enlargement.
8) Pregnant and/or lactating mothers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Plaque Index (P.I)
Tureskey-Gilmore-Glickman Modification of Quigley Hein)
2.Gingival Index (G.I) (Loe and Sillness,1963)
3.Probing Pocket Depth (PPD)
4.Clinical Attachment Level (CAL) |
1) At Baseline
2) After 1 month
3) After 3 month
4) After 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The radiographic bone fill will be evaluated using Intraoral Periapical Radiographs of the surgical site. |
Baseline- at baseline,immediately after the surgery and 6 months post surgery |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2022 |
| 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="8"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 19-09-2022 and end date provided 19-07-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Aim and Objective: To evaluate and compare clinically and radiographically efficacy of Bovine Derived Xenograft (Fix-Oss â„¢) with Advanced Platelet Rich Fibrin Plus (A-PRF+) and Bovine Derived Xenograft (Fix-Oss â„¢) with Injectable Platelet Rich Fibrin (i-PRF) when used in the treatment of Intrabony Defects in Chronic Periodontitis Patients.
Material and Methods:
Forty-four intabony defects were randomly allocated to two different groups and were treated with group A (Bovine Derived Xenograft (Fix-Oss â„¢) with Advanced Platelet Rich Fibrin Plus (A-PRF+) and group B ( Bovine Derived Xenograft (Fix-Oss â„¢) with Injectable Platelet Rich Fibrin (i-PRF).Clinical Parameters such as Plaque Index (P.I.), Gingival Index (G.I.) ,Probing Pocket Depth (PPD) , Clinical Attachment Level (CAL) were recorded at baseline 1 month ,3 months post- surgery, and 6 months post-surgery. Radiographic parameter such as percentage in bone fill (%BF) were calculated by using computerized image analysis software.
Data collected will be compiled on to a MS Office excel worksheet & will be subjected to statistical analysis using an appropriate package like SPSS software.
Normality of numerical data will be checked using Shapiro – Wilk test or Kolmogorov-Smirnov test. Depending on the normality of data, statistical tests will be determined.
For a numerical continuous data following a normal distribution, inter group comparison (2 groups) will be done using t test, else a non parametric substitute like Mann Whitney U test will be used.
Descriptive statistics like frequency (n) & percentage (%) of categorical data, mean & Standard deviation of numerical data in each group will be depicted & may be compared using chi square test or a suitable test like Fisher’s exact test / McNemar test based on the data obtained.
Intra group comparisons for a numerical continuous data following a normal distribution will be done using paired t test (for 2 observations) or repeated measures ANOVA for >2 observations, else a non parametric substitute like Wilcoxon signed rank test (for 2 observations) or Friedman’s test for >2 observations will be used.
Keeping alpha error at 5% and Beta error at 20%, power at 80%, p<0.05 will be considered statistically significant. |