| CTRI Number |
CTRI/2024/07/070712 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Egg shell derived Nano-hydroxyapatite as a regenerative material in Direct Sinus Augmentation. |
|
Scientific Title of Study
|
Effect of Egg shell derived Nano-Hydroxyapatite (EnHA) in Direct Sinus Augmentation (DSA)- An Analytical Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vikrant Dilip Sane |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be) University Dental College and Hospital Pune |
| Address |
106, Department of Oral and Maxillofacial Surgery, Bharati Vidyapeeth (Deemed to be) University Dental College and Hospital, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8668639527 |
| Fax |
|
| Email |
vikrant.sane@bharatividyapeeth.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajesh Kshirsagar |
| Designation |
Professor and Head of the department |
| Affiliation |
Bharati Vidyapeeth (Deemed to be) University Dental College and Hospital Pune |
| Address |
106, Department of Oral and Maxillofacial Surgery, Bharati Vidyapeeth (Deemed to be) University Dental College and Hospital, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9822042097 |
| Fax |
|
| Email |
rajesh.kshirsagar@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Vikrant Dilip Sane |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be) University Dental College and Hospital Pune |
| Address |
106, Department of Oral and Maxillofacial Surgery, Bharati Vidyapeeth (Deemed to be) University Dental College and Hospital, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8668639527 |
| Fax |
|
| Email |
vikrant.sane@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be) University Dental College and Hospital, Pune 411043 India |
|
|
Primary Sponsor
|
| Name |
DrVikrant Dilip Sane |
| Address |
106- DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, BVDU DENTAL COLLEGE AND HOSPITAL, PUNE |
| 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 Vikrant Dilip Sane |
Bharati Vidyapeeth (Deemed to be) University Dental College and Hospital, Pune |
106, Department of Oral and Maxillofacial Surgery
Pune
MAHARASHTRA |
08668639527
vikrant.sane@bharatividyapeeth.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BHARATI VIDYAPEETH (DEEMED TO BE) UNIVERSITY DENTAL COLLEGE AND HOSPITAL PUNE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Egg shell derived nano-hydroxyapatite |
Egg shell derived nano-hydroxyapatite will be mixed with concentrated growth factor and will be grafted at the time of direct sinus augmentation procedure once. |
| Comparator Agent |
NO TREATMENT |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Partially or completely edentulous posterior maxilla with residual height less than equal to 5mm.
2. 6 months gap between tooth extraction and implant placement.
3. Presence of healthy or restored adjacent teeth.
4. Patients with ASA category I or II.
5. Excellent oral hygiene.
|
|
| ExclusionCriteria |
| Details |
1. Uncontrolled metabolic diseases, compromised immune system, haematological disorders, pregnancy, prior radiotherapy of maxillofacial region, chemotherapy, bone disease, medication or any other systemic illness which may affect prognosis of the treatment.
2. Radiographic evidence of maxillary sinus pathology.
3. History of sinusitis or maxillary sinus surgery.
4. Inadequate mouth opening.
5. Patients with habits of smoking, tobacco chewing, alcoholism, etc.
6. Patients not willing for egg shell derived graft material.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CBCT scan will be used to determine density of bone and level of alveolar bone height, histomorphometric analysis will be used to evaluate presence of residual graft material and replacement of grafted material by host bone alongwith any resorptive or inflammatory changes. |
180 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| OPG will be taken to assess the stage of bone formation & clinical examination will be done to assess soft tissue healing |
90 days |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/07/2024 |
| 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 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
|
Resorption of alveolar ridge and
pneumatization of maxillary sinus makes the rehabilitation of posterior maxilla
very challenging for which bone grafting is often required to make implant
placement possible. The aim of this study is to evaluate the effectiveness of EnHA
mixed with CGF in direct sinus augmentation procedure.
EnHA will be obtained from department of clinical
research, Sibar institute of dental sciences, Guntur ap, in the biomedical
material science laboratory, department of physics, Periyar university, Salem, Tamil
Nadu, under department of science and technology, government of india funded
project with grant no.- dst/tdt/wmt/agwaste/2021/01(g).
A pre-operative CBCT scan of maxillary arch will be
made to see the available bone height in maxillary posterior region. Patients
as per inclusion critera will be enrolled in the study after obtaining informed
consent. Sinus lift procedure will be performed by lateral approach and EnHA
with CGF will be grafted. Surgical wound will be sutured with 3-0 mersilk.
Suture removal will be done on 10th postoperative day and patient would be
followed up after 30 days, 90 days and 180 days.
CBCT scan will be made after 180 days to assess the
bone quality. Dental implant of suitable dimension will be placed followed by
placement of cover screw and subsequent prosthetic rehabilitation. 2mm trephine
will be used to remove bone just prior to implant placement and will be sent
for histomorphometric analysis.
|