| CTRI Number |
CTRI/2024/03/064064 [Registered on: 13/03/2024] Trial Registered Prospectively |
| Last Modified On: |
08/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Bone healing in dental patients |
|
Scientific Title of Study
|
Comparative Evaluation of Periapical healing in patients with mature teeth using A-PRF+ and i-PRF with Apical Periodontitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrTejas Suryawanshi |
| Designation |
post graduate student |
| Affiliation |
Sharad Pawar Dental College and Hospital |
| Address |
103,department of conservative dentistry, Sharad pawar dental college and hospital sawangi meghe wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
07057380987 |
| Fax |
|
| Email |
tejassuryawanshi8997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradnya nikhade |
| Designation |
professor department of conservative dentistry and endodontics |
| Affiliation |
Sharad pawar dental college and hospital |
| Address |
103,department of conservative dentistry, Sharad pawar dental college and hospital sawangi meghe wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7447463783 |
| Fax |
|
| Email |
drpradnyanikhade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrTejas Suryawanshi |
| Designation |
PG student department of conservative dentistry and endodontics |
| Affiliation |
Sharad pawar dental college and hospital |
| Address |
103, Sharad Pawar Dental College & Hospital, Datta Meghe institute of Medical Sciences, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
07057380987 |
| Fax |
|
| Email |
tejassuryawanshi8997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sharad pawar dental College and hospital, Sawangi , Wardha , Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Tejas Suryawanshi |
| Address |
103,department of conservative dentistry, Sharad pawar dental college and hospital sawangi meghe wardha |
| Type of Sponsor |
Other [self funded study] |
|
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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 Tejas Suryawanshi |
Sharad pawar dental college and hospital wardha |
103, SHARAD PAWAR DENTAL COLLEGE AND HOSPITAL DATTA MEGHE INSTITUE OF HIGHER EDUCATION AND RESEARCH
SAWANGI WARDHA
Wardha
MAHARASHTRA |
7057380987
tejassuryawanshi8997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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: K049||Other and unspecified diseases ofpulp and periapical tissues, (2) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
APRF plus |
Glass tubes will be used to collect the blood that is extracted from the median cubital vein 10 mL The blood was then centrifuged in the Dentrifuge Machine for 8 minutes at 1200 rpm to produce advanced platelet-rich fibrin plus For the purpose of draining the liquid and forming a fibrin membrane the fibrin clot will be squeezed between two pieces of sterile gauz Pushing will then be done using Machtou hand pluggers In accordance with the manufacturers recommendations White Pro root MTA by Dentsply Maillefer will be mixed and 2mm of MTA barrier will be positioned above it. This will be accomplished in single appointment after confirming asymptomatic condition of patient, with subsequent follow up.Duration of procedure 7 days |
| Intervention |
introduction of iprf into periapical lesions with orthograde approach |
i-PRF will be introduced into the canal and will be pushed gently with 15 gauge needled syringe 1mm short of Working length
White Pro root MTA by Dentsply Maillefer will be mixed in accordance with the manufacturers instructions 2mm of MTA barrier will be placed above it
Next, the canals will be finally obturated and filled by a thermoplastic method with a calibrated gutta-percha cone and MTA based sealer
duration of intervention will be of single appointment after confirming asymptomatic condition of patient, with subsequent follow up.
Duration of procedure 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects Will have a mature, single-rooted, necrotic anterior tooth.
2. The chosen individuals will be free of systemic illness and known allergic responses to any of the prescribed antibiotics.
|
|
| ExclusionCriteria |
| Details |
1. Individuals with peripheral vascular diseases, cancer, diabetes mellitus, and coronary artery disease.
2. Those receiving long-term corticosteroid therapy.
3.Those who are immunocompromised.
4.Females who are expecting or nursing.
5.Those who have chronic widespread periodontitis.
6.Patients with teeth that cannot be restored.
7.Teeth that have undergone root canal therapy.
8.Teeth having abnormal development.
9.Internal and externally resorbing teeth.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of APRF in the management of patients with mature permanent teeth for periapical bone healing using an IOPA radiograph
To evaluate the efficacy of PRF in the management of patients with mature permanent teeth for periapical bone healing using an IOPA radiograph
To compare the efficacy of iPRF & APRF in the management of patients with mature permanent teeth for periapical bone healing using an IOPA radiograph
|
all the outcomes will be assessed on T0-on the day, T1 -6 months T2- 12 months with Intra oral peeriapicaal radiograph |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 4 |
|
Date of First Enrollment (India)
|
19/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
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
|
Background: Delayed Periapical healing is a common finding in treated root canals. Various additive and alterations have been tried in order to hasten the healing process in literature. Platelet concentrates have been studied in dentistry with satisfactory results but the clot like form of these concentrates was not in favour of Endodontist in closed apex cases due to consistency of the concentrates. Recently Injectable PRF (iPRF) is being used in dermatology, Orthopedics due to good amount of growth factors and liquid like consistency. Objectives: To evaluate and compare the efficacy of A-PRF+ and i-PRF in periapical healing of patients with mature permanent teeth radiographically. Materials and Methods: A total of 34 patients with Apical Periodontitis related to permanent central incisors will be included in the study. The Subjects will undergo conventional Access opening, Biomechanical preparation and irrigation. In control group (n=17) freshly made APRF+ will be pushed out of the root apex with help of pluggers. While in the intervention group (n=17) freshly made iPRF will be injected beyond the root apex. MTA barrier of 2 mm will be placed above it and the teeth will be sealed thermoplastically by Gutta percha in both the groups. Intra Oral Periapical Radiographs will be taken T0 (on the day), T1 (6 months) T2 (12 months) to assess Periapical healing post operatively. Expected outcome: iPRF is expected to outperform APRF+ in periapical healing because of the intricate and tapered form of Dental Root Canal Systems liquid consistency of the material may be favorable when compared to semisolid clot like consistency of APRF+. Keywords: Periapical Bone healing, iPRF, APRF+, Apical Periodontitis. |