| CTRI Number |
CTRI/2022/07/043959 [Registered on: 13/07/2022] Trial Registered Prospectively |
| Last Modified On: |
12/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of wound healing after tooth removal using eggshell derived material covered with blood component and with eggshell derived material alone |
|
Scientific Title of Study
|
Evaluation of extraction socket healing with Naturally sourced (Eggshell derived) Nano-hydroxyapatite graft covered with Platelet Rich Fibrin (PRF) and extraction socket filled with Naturally sourced Nano-hydroxyapatite graft alone - A prospective study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1278-8009 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Panga Gnana Sarita Kumari |
| Designation |
Project Assistant |
| Affiliation |
SIBAR Institute of Dental Sciences |
| Address |
Department of Clinical Research, SIBAR Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh, India.
Guntur ANDHRA PRADESH 522509 India |
| Phone |
8341201041 |
| Fax |
|
| Email |
drpgsarita@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Vivekanand Kattimani |
| Designation |
Professor and Head |
| Affiliation |
SIBAR Institute of Dental Sciences |
| Address |
Department of Clinical Research, SIBAR Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh, India.
Guntur ANDHRA PRADESH 522509 India |
| Phone |
9912400988 |
| Fax |
|
| Email |
drvivekanandsk@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Vivekanand Kattimani |
| Designation |
Professor and Head |
| Affiliation |
SIBAR Institute of Dental Sciences |
| Address |
Department of Clinical Research, SIBAR Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh, India.
Guntur ANDHRA PRADESH 522509 India |
| Phone |
9912400988 |
| Fax |
|
| Email |
drvivekanandsk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Science and Technology, Government of India |
|
|
Primary Sponsor
|
| Name |
Department of Science and Technology |
| Address |
Department of Science and Technology, Ministry of Science and Technology, Government of India, New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Panga Gnana Sarita Kumari |
SIBAR Institute of Dental Sciences |
Department of Clinical Research, Ground Floor, SIBAR Institute of Dental Sciences, Takkellapadu, Guntur Guntur ANDHRA PRADESH |
8341201041
drpgsarita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, SIBAR Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Eggshell Derived Nanohydroxyapatite Graft closed with suture |
Eggshell Derived Nanohydroxyapatite Graft closed with figure-of-eight suture and after 7 days the suture removal will be done |
| Intervention |
Eggshell Derived Nanohydroxyapatite Graft covered with Platelet rich Fibrin membrane with suture |
Eggshell Derived Nanohydroxyapatite Graft covered with Platelet rich Fibrin membrane and closed with figure-of-eight suture and after 7 days the suture removal will be done |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between 18-45 years with physical status falling under the category of ASA I and II. 2. Patients undergoing atraumatic extraction for grossly decayed or non-restorable teeth or periodontally weakened teeth. 3. Subjects who are willing to take part in the study. |
|
| ExclusionCriteria |
| Details |
1. Any abnormal findings during clinical or radiological examination.
2. Immunosuppressive conditions such as AIDS, Cancer or Radiation therapies.
3. Pregnant/Lactating women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Soft Tissue Healing using Modified Laundry et al. Index
• Pain using Modified Wong-Baker Faces Pain Rating Scale
• Measurement of Alveolar Height and Width |
1) On 7th day
2) On 14th day
3) On 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient Comfort level will be assessed after the procedure on three time points |
7th, 14th and 90th day |
|
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
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)
|
15/07/2022 |
| 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)
|
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
|
|
Brief Summary
|
This study is a randomized, parallel active controlled trial evaluating the healing of extraction socket with eggshell derived nanohydroxyapatite graft covered with platelet rich fibrin and eggshell derived nanohydroxyapatite graft alone and this study will be conducted in the department of Clinical Research.
The study subjects will be enrolled from the out-patient department of Oral and
Maxillofacial Surgery. They will be randomly allocated into two groups and the
consent will be obtained from the participants. The study participants will
undergo atraumatic extraction. After achievement of post extraction hemostasis,
nano-hydroxyapatite graft will be placed into the extraction socket till the
crestal level and PRF membrane will be placed over the grafted socket and
tucked between Buccal and Lingual/Palatal gingiva and stabilized using 3-0
black silk suture (figure of eight) in one group. In another group,
nano-hydroxyapatite graft alone will be placed into extraction sockets up to
the crestal level and will be sutured using 3-0 black silk suture (figure of
eight). After the procedure, the subjects will be advised to follow post
extraction instructions. All the subjects will be followed up for 90 days for
any adverse events and the parameters like soft tissue healing, pain and alveolar width and height will be assessed on 7th, 14th
and 90th day post operatively.
Preparation of Platelet Rich Fibrin (PRF) membrane: This will be prepared using autologous blood under standard aseptic
precautions. Intravenous blood of 5 ml will be drawn from the precubital region
using a sterile disposable syringe. Blood will be centrifuged using a tabletop
centrifuge for 10 minutes at 3000 rpm immediately. The resultant product will
consist of acellular plasma at the top, PRF clot in the middle, and red blood
cells at the bottom. PRF component will be separated and molded into a thin
sheet of approximately 1x1 using a sterile wet gauze piece. |