| CTRI Number |
CTRI/2024/05/067824 [Registered on: 22/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Compare the effect of AbGel and bone graft |
|
Scientific Title of Study
|
Comparative evaluation of the efficacy of i-PRF with AbGelTM and i-PRF with bone graft in the treatment of intrabony 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. Jatin Chauhan |
| Designation |
Junior resident |
| Affiliation |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
| Address |
Room no. 426, Department of periodontology, Faculty of Dental Sciences, 4th floor old building, Uttar Pradesh University of Medical Sciences, Saifai, Etawah
Room no. 426, Department of periodontology, Faculty of Dental Sciences, 4th floor old building, UPUMS, Saifai, Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7906838228 |
| Fax |
|
| Email |
jatinchauhan40.jc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajesh Kumar Thakur |
| Designation |
Professor |
| Affiliation |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
| Address |
Room no. 414, Department of Periodontology, Faculty of Dental Sciences, 4th floor old building, Uttar Pradesh University of Medical Sciences, Saifai, Etawah
Room no. 414, Department of Periodontology, Faculty of Dental Sciences, 4th floor old building, UPUMS, Saifai, Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9997060666 |
| Fax |
|
| Email |
dr.rkthakurperio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Jatin Chauhan |
| Designation |
Junior resident |
| Affiliation |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
| Address |
Room no. 426, Department of Periodontology, Faculty of Dental Sciences, 4th floor old building, Uttar Pradesh University of Medical Sciences, Saifai, Etawah
Room no. 426 Department of Periodontology, Faculty of Dental Sciences, 4th floor old building, UPUMS, Saifai, Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7906838228 |
| Fax |
|
| Email |
jatinchauhan40.jc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Jatin Chauhan Department of periodontology, Faculty of dental sciences 4th floor old building UP University of medical sciences saifai etawah 206130 India |
|
|
Primary Sponsor
|
| Name |
Dr Jatin Chauhan |
| Address |
Room no. 426 Department of periodontology Faculty of dental sciences 4th floor old building UP University of medical sciences saifai etawah 206130 India |
| 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 Jatin Chauhan |
Uttarpradesh university of medical sciences saifai |
Room no. 426 Department of periodontology, Faculty of dental sciences 4th floor old building, UPUMS saifai etawah 206130 India
Etawah
UTTAR PRADESH |
7906838228
jatinchauhan40.jc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Uttarpradesh University of Medical Sciences 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 |
AbGelTM |
dose: depending upon intrabony component
frequency route of administration: During flap surgery only
total duration of such intervention: 6 months |
| Comparator Agent |
Bone graft (Hydroxyapatite and Beta-TCP bone graft) |
dose: depending upon intrabony component
frequency route of administration: During flap surgery only
total duration of such intervention: 6 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients with moderate to severe chronic periodontitis.
Probing pocket depth ≥6mm with intrabony defects.
Nearly bilateral symmetrical sites.
Systemically healthy patients
|
|
| ExclusionCriteria |
| Details |
Smoker or alcoholic
Pregnant or lactating women
Patients on any kind of medications
Defects in association with malformed root or root deformity
Third molar
Participants who have undergone surgical periodontal therapy with a period of past 6 months.
perio-endo lesions |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Plaque index
Gingival index
PPD and CAL
Bone defect depth
bone defect width
bone fill |
Plaque index
Gingival index
PPD and CAL at baseline (during surgery), 3 months and 6 months.
Bone defect depth
bone defect width
bone fill at baseline ( during surgery) and at 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| clinical parameters |
baseline. 3 months & 6 months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
06/06/2024 |
| 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)
|
Open to Recruitment |
| 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
|
Aim: To compare the efficacy of i-PRF with AbGelTM and i-PRF with bone graft in the treatment of intrabony defects. Research Hypothesis: To know the effect of i-PRF with AbGelTM in the management of intrabony defect and to compare it with i-PRF with bone graft |