| CTRI Number |
CTRI/2018/06/014580 [Registered on: 20/06/2018] Trial Registered Retrospectively |
| Last Modified On: |
15/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study comparing the effectiveness between PRF and hydroxyapatite graft material placement after removal of periapical cyst |
|
Scientific Title of Study
|
A comparative clinical evaluation of efficacy of PRF and hydroxyapatite granules in surgical management of periapical pathological defects |
| Trial Acronym |
EOPAHGPAD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
B Shravya Kalavant |
| Designation |
Final year post graduate student |
| Affiliation |
Sri hasanamba dental college and hospital |
| Address |
Room no 2, Department of Oral and Maxillofacial Department
Sri hasanamba dental college and hospital, vidyanagar
Hassan
Room no 2, Department of Oral and Maxillofacial Department
Sri hasanamba dental college and hospital, vidyanagar
Hassan
Hassan KARNATAKA 573202 India |
| Phone |
9743702388 |
| Fax |
|
| Email |
kavyakalavant@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
MANJUNATH K S |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
Sri hasanamba dental college and hospital |
| Address |
Room no 2, ground floor
Department of Oral and Maxillofacial Surgery
Sri hasanamba dental college and hospital, vidya nagar
Hassan Room no 2, ground floor
Department of Oral and Maxillofacial Surgery
Sri hasanamba dental college and hospital, vidya nagar
Hassan Hassan KARNATAKA 573202 India |
| Phone |
9743779536 |
| Fax |
|
| Email |
manjunath_kurki@yahoo.in |
|
Details of Contact Person Public Query
|
| Name |
Manjunath K S |
| Designation |
Professor and HOD |
| Affiliation |
Sri hasanamba dental college and hospital |
| Address |
Room no 2, Department of Oral and Maxillofacial Surgery
Sri hasanamba dental college and hospital, vidya nagar
Hassan
Hassan KARNATAKA 573202 India |
| Phone |
9743779536 |
| Fax |
|
| Email |
manjunath_kurki@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Room no 2, Department of Oral and Maxillofacial Surgery
Sri hasanamba dental college and hospital, vidya nagar
Hassan |
|
|
Primary Sponsor
|
| Name |
Sri hasanamba dental college and hospital |
| Address |
Room no 2, Department of Oral and Maxillofacial Surgery
Sri hasanamba dental college and hospital, vidya nagar
Hassan |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| B SHRAVYA KALAVANT |
Sri hasanamba dental college and hospital |
Room no 2 Department of Oral and maxillofacial department
Sri hasanamba dental college and hospital vidyanagar
hassan 573202 Hassan KARNATAKA |
9743702388
kavyakalavant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients with periapical cyst in jaws |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
hydroxyapatite graft |
placement of hydroxyapatite graft after removal of periapical cyst in the jaws and regular follow up for 6 months. |
| Intervention |
platelet rich fibrin graft |
placement of prf graft after removal periapical cyst in the jaws and regular follow up for 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age: - 18 years and above of both sexes
The tooth to be treated should have a periradicular lesion and for which nonsurgical treatment alone is considered insufficient or retreatment is considered unfeasible or had previously failed.
Periapical pathology in anterior region of maxillary and mandibular region.
The diameter of the bone defect, as will be determined from the intraoral periapical radiographs, should be up to 2 cm x 2cm in diameter.
|
|
| ExclusionCriteria |
| Details |
Patients in whom surgery is medically contraindicated.
Age less than 18 years.
Immuno-compromised and patients with metabolic disorders.
An active infection or a history of persistent infections.
The diameter of bony defect more than 2 cm× 2 cm as determined from the intra oral periapical radiograph.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| it was concluded that both the graft materials prf and hydroxyapatite were efficient in improving clinical parameters as well as regenerative effects when used in the treatment of periapical defect |
it was concluded that both the graft materials prf and hydroxyapatite were efficient in improving clinical parameters as well as regenerative effects when used in the treatment of periapical defect |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
nil
|
nil |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/01/2016 |
| Date of Study Completion (India) |
20/08/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="7" Days="21" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
For complete regeneration, delivery of growth factors in the local environment holds a great deal of adjunct to bone grafts. Platelet rich fibrin (PRF) is considered as second generation platelet concentrate, consisting of viable platelets, releasing various growth factors. Hence, this study aims to investigate the clinical and radiological (bone fill) effectiveness of autologous PRF and synthetic Hydroxyapatite granules in the treatment of periapical defect bony defects.
Aim and Objective: Comparison of the efficacy of PRF and HA bone grafts in periradicular surgery by clinical and radiographic evaluation.
Study Design/Methodology: A randomised clinical trial was conducted in patients who were assigned for periradicular surgery. 20 patients were included in this study and were divided into 2 groups. The patients were randomly assigned for the surgery, received synthetic HA graft and PRF obtained from the patient in the respective assigned groups. A clinical and radiographic evaluation was performed postoperatively at the period of 1 month, 3 months and 6 months.
Results: There was no statistical difference in clinical healing as well as reduction in defect size radiographically in both the groups. Although both the biomaterials were seen to enhance the rate of bone deposition and can be used as an adjuvant in the treatment of periapical defects. Conclusion: It was concluded from the study that a good quality apical seal can be obtained using root‑end filling materials contributing to the success of the treatment. To further enhance the success rate, grafts, and various host modulating agents can be used. HA crystals used as grafts are bioactive materials that promote the formation of new bone. However, PRF is preferred over grafts as it is autologous and promotes faster healing by release of growth factors needed for the formation of bone |