| CTRI Number |
CTRI/2021/03/031929 [Registered on: 11/03/2021] Trial Registered Prospectively |
| Last Modified On: |
05/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparative evaluation of bone graft with a blood product and bone graft alone in treatment of bone defects created by gum diseases. |
|
Scientific Title of Study
|
“Comparative Clinical and Radiographic Evaluation of the Efficacy of Autologous Injectable Platelet-Rich Fibrin (iPRF) with Demineralized freeze dried bone allograft (DFDBA) and Normal Saline with Demineralized freeze dried bone allograft (DFDBA) 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 BHALCHANDRA THORAT |
| Designation |
First year PG in periodontics |
| Affiliation |
Nair hospital and dental college |
| Address |
201, Department of periodontics, second floor, Nair hospital dental college opposite to Maratha Mandir Mumbai central- 400008
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7249590890 |
| Fax |
|
| Email |
bmbt5691@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MALA DIXIT BABURAJ |
| Designation |
Professor and H.O.D of the department |
| Affiliation |
Nair hospital dental college |
| Address |
201,Department of periodontics Nair hospital dental college opposite to Maratha Mandir Mumbai central- 400008
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 H.O.D of the department |
| Affiliation |
Nair hospital and dental college |
| Address |
201,Department of periodontics Nair hospital dental college opposite to Maratha Mandir Mumbai central- 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9223340938 |
| Fax |
|
| Email |
maladixit25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nair Hospital Dental College Mumbai central 400008 |
|
|
Primary Sponsor
|
| Name |
DR BHALCHANDRA THORAT |
| Address |
201,Department of periodontics
Nair hospital and dental college opposite to maratha mandir, mumbai central- 400008 |
| Type of Sponsor |
Other [self sponsored] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR BHALCHANDRA THORAT |
Nair hospital dental college |
Department of periodontics,201
Mumbai
MAHARASHTRA |
7249590890
bmbt5691@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee NHDC |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K05||Gingivitis and periodontal diseases, (2) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Demineralized freeze dried bone allograft with injectable platelet rich fibrin |
After centrifugation, the blood is separated into a yellow orange upper phase (i-PRF) and a red lower phase. The yellow part will be collected using a syringe and added to a cup that contains the bone graft material. The collected i-PRF maintains its fluid phase for up to 10 to 15 minutes after centrifugation. The i-PRF consolidated bone graft will placed in to the intraosseous defect.Patients will be evaluated clinically at1,3,6 months postoperatively |
| Intervention |
Demineralized freeze dried bone allograft with normal saline |
Open flap debridement, followed by placement of Normal saline with
demineralized freeze-dried bone allograft (DFDBA) in the infrabony defect.Patients will be evaluated clinically at 1,3,6 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 20-60years
Diagnosis with chronic periodontitis
Patients in good systemic health with no contraindication to periodontal surgery
Patients having Intrabony defects with pocket depths of 5mm or more,intrabony defect of 3mm with radiographic evidence of vertical / angular bone loss in the affected sites.
Involved teeth to be vital and with no endodontic lesion. |
|
| ExclusionCriteria |
| Details |
One — wall osseous defects.
Patients suffering from any systemic diseases or with compromised immune system.
Patients who had received any type of periodontal therapy for the past 6 months
Patients taking any immuno-suppressive drugs like corticosteroids.
Patients with a known history of allergy to doxycycline or Chlorhexidine or any other medicine are used in the study.
Patients showing unacceptable oral hygiene compliance during /after the phase I therapy.
Patients taking any drug known to cause gingival enlargement.
Pregnant and/or lactating mothers.
Patients who were smokers or had tobacco in any other form.
Endodontically treated teeth.
Patient on anticoagulant therapy
Patient with bleeding disorders. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Plaque index(SILNESS & LOE 1964)
Gingival index(LOE & SILNESS 1963)
Probing pocket depth(PPD)
Clinical attachment Level(CAL) |
baseline 1 month 3months and 6 months postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Radiographic bone fill will be evaluated using intraoral periapical radiographs of the surgical site. |
Radiographs will be taken immediatly post surgery and at six month post surgery |
|
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Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
19/03/2021 |
| 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="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 - NO
|
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Brief Summary
|
Regeneration of lost structures has become the primary therapeutic goal in periodontics. The objectives of periodontal regenerative therapy are to reconstitute the bone, cementum and periodontal ligament on a previously diseased root surface. Numerous therapeutic modalities for restoring periodontal osseous defects have been investigated. Many of these procedures include the use of bone grafts and bone replacement materials. For the last few decades, demineralized freeze-dried bone allograft (DFDBA) has been used alone and in combination with other treatment modalities for periodontal regeneration. The presence of bone morphogenetic proteins contained within DFDBA aids in mesenchymal cell migration, attachment, and osteogenesis.
To evaluate and compare clinically and radiographically the effect of Autologus injectable platelet–rich fibrin (iPRF) with demineralized freeze-dried bone allograft(DFDBA) v/s Normal saline with demineralized freeze-dried bone allograft(DFDBA)in the treatment of infrabony periodontal defect and its effecton clinical parameter like Plaque index, Gingival index, Probing pocket depth and Clinical attachment level. |