| CTRI Number |
CTRI/2022/07/043845 [Registered on: 08/07/2022] Trial Registered Prospectively |
| Last Modified On: |
16/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of healing in grafted and non-grafted tooth removed sites |
|
Scientific Title of Study
|
Evaluation of healing of extraction socket with and without Naturally Sourced (Eggshell derived) Nano-hydroxyapatite graft - A prospective study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1278-7154 |
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 Biotechnology, Government of India |
|
|
Primary Sponsor
|
| Name |
Department of Biotechnology |
| Address |
Department of Biotechnology, 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 |
Ground Floor, Room No.3, Department of Oral and Maxillofacial Surgery and Department of Clinical Research
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 |
| Intervention |
Eggshell Derived Nanohydroxyapatite Graft |
Nanohydroxyapatite Graft is a naturally sourced graft from eggshell that can be used for bone formation in extraction sockets. |
| Comparator Agent |
No eggshell derived nanohydroxyapatite graft will be placed |
No bone graft will be placed and the socket will be healed without any graft intervention. The comparator will be normal socket healing |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between l8-45 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. Extraction sites that do not require primary closure or suturing. 4. 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 group trial evaluating the healing of extraction socket with and
without eggshell derived nanohydroxyapatite graft and 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 in one group. In
another group, pressure pack is applied to the extraction socket. 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. |