| CTRI Number |
CTRI/2024/02/062436 [Registered on: 08/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TREATMENT OF INTRABONY DEFECTS USING A-PRF BLOCK WITH OR WITHOUT THE INCORPORATION OF METRONIDAZOLE COMPARED TO MIXTURE OF A-PRF+i-PRF ALONE: A RANDOMIZED CONTROLLED CLINICAL TRIAL |
|
Scientific Title of Study
|
CLINICAL AND RADIOGRAPHIC EVALUATION OF ADVANCED-PLATELET RICH FIBRIN BLOCK WITH AND WITHOUT METRONIDAZOLE INFUSION COMPARED TO A MIXTURE OF A-PRF+ i-PRF ALONE IN THE MANAGEMENT OF PERIODONTAL INTRABONY DEFECTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TRUSHA KISHORE PEDNEKAR |
| Designation |
DR (PG STUDENT) |
| Affiliation |
GOA DENTAL COLLEGE AND HOSPITAL |
| Address |
GOA DENTAL COLLEGE AND HOSPITAL, DEPARTMENT OF PERIODONTICS, NUMBER 4, BAMBOLIM- GOA
403202
North Goa
GOA
403521
India |
| Phone |
7020659978 |
| Fax |
|
| Email |
trushapednekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
JAMES SAMUEL |
| Designation |
DR (PROFESSOR AND HEAD OF DEPARTMENT |
| Affiliation |
GOA DENTAL COLLEGE AND HOSPITAL |
| Address |
GOA DENTAL COLLEGE AND HOSPITAL, DEPARTMENT OF PERIODONTICS, NUMBER 4, BAMBOLIM- GOA
403202
North Goa
GOA
403202
India |
| Phone |
98222151608 |
| Fax |
|
| Email |
jamessamueldental@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
TRUSHA KISHORE PEDNEKAR |
| Designation |
DR (PG STUDENT) |
| Affiliation |
GOA DENTAL COLLEGE AND HOSPITAL |
| Address |
GOA DENTAL COLLEGE AND HOSPITAL, DEPARTMENT OF PERIODONTICS, NUMBER 4, BAMBOLIM- GOA
403202
GOA
403521
India |
| Phone |
7020659978 |
| Fax |
|
| Email |
trushapednekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. TRUSHA KISHORE PEDNEKAR |
| GOA DENTAL COLLEGE AND HOSPITAL
|
|
|
Primary Sponsor
|
| Name |
DR TRUSHA KISHORE PEDNEKAR |
| Address |
GOA DENTAL COLLEGE AND HOSPITAL, DEPARTMENT NUMBER 4, BAMBOLIM GOA 403202 |
| 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 TRUSHA PEDNEKAR |
GOA DENTAL COLLEGE AND HOPSITAL |
DEPARTMENT OF PERIODONTICS, ROOM NUMBER 4, BAMBOLIM-GOA
North Goa
GOA |
7020659978
trushapednekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOA DENTAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUP A:MIXTURE OF A-PRF + i-PRF |
Following open flap debridement (OFD),Mixture OF A-PRF + i-PRF will be placed in the intrabony defect. A-PRF will be made by centrifuging 4ml of blood at 1500rpm for 14mins and i-PRF at 700rpm for 3mins.
|
| Intervention |
GROUP B : A-PRF + i-PRF +DFDBA
|
Following open flap debridement (OFD), mixture of A-PRF + i-PRF + DFDBA will be placed in the intrabony defect. A-PRF and i-PRF will be prepared as explained earlier. DFDBA is demineralized freeze dried bone allograft. |
| Intervention |
GROUP C : A-PRF + i-PRF +DFDBA + Metronidazole |
Following open flap debridement (OFD), a mixture of A-PRF + i-PRF + DFDBA + Metronidazole will be placed in the intrabony defect. In this group, 2ml of metronidazole will be added to blood prior to centrifugation at 1500rpm for 14mins to prepare A-PRF infused with metronidazole.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female patients with chronic periodontitis
2.With a platelet count within normal limits
3.Presence of atleast one or two sites with probing pocket depth (PPD) of more than 6 mm
4.Three-walled defect with depth of more than 3 mm, as confirmed by cone beam computed tomography (CBCT)
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy and lactation
2.Smokers and tobacco users
3.Hypertension
4.Diabetes
5.Any other systemic disorders which affect the outcome of the treatment
• Patients who are unwilling to participate in the study |
|
|
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 |
Defect fill (change in distance from cement enamel junction to Base of defect from baseline to 9 months) will be recorded
Defect resolution (change in distance from Alveolar Crest to base of defect from baseline to 9 months) will be recorded
|
baseline and after 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Plaque index(PI)
Gingival index (GI)
Pocket probing depth (PPD)
Relative attachment level (RAL)
|
baseline and after 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
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/02/2024 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
•Periodontitis is a polymicrobial disease where the inflammatory process results in progressive tissue destruction. The ultimate aim of periodontal therapy is to arrest the disease progression and to regenerate the lost tissues. Till date, several procedures have been developed in an attempt to regenerate the lost bone with the use of various bone graft materials, guided tissue regeneration, and/or the combination therapy with growth factors. Platelet rich fibrin (PRF) is the second generation autologous platelet concentrate introduced by Choukroun et al. in 2001. Various modifications of PRF clots have been introduced by reducing the speed and increasing time which exhibited promising outcome for the clinicians to perform research. Recently, a novel method of “PRF block†consisting of pieces of L PRF mixed with i-PRF and bone graft formed into a cohesive block was proposed. This block forms a volumetric matrix which can be used to fill various osseous defects. In A-PRF block, the cut membrane of the A-PRF acts as a biological matrix and promotes migration of osteoprogenitor cells to the centre of the graft. Demineralized Freeze-dried Bone Allograft (DFDBA) will be used in this study to prepare A-PRF block. Evaluation of the efficacy of antibiotic infusion in A-PRF block for the treatment of intraosseous defects has never been tried earlier. This study is designed to evaluate clinically and radiographically the effect of advanced-platelet rich fibrin block(A-PRF+i-PRF+DFDBA) with or without antibiotic-infusion compared to a mixture of A-PRF+ i-PRF alone in the management of periodontal intrabony defects |