| CTRI Number |
CTRI/2024/06/068965 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on the effect of egg shell derived material for treatment of jaw bone defects |
|
Scientific Title of Study
|
Evaluation of the efficacy of Egg Shell derived NanoHydroxyapatite graft in Intrabony defects: A Clinical and Radiographic 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 |
DrRavi Kumar Saka |
| Designation |
Post graduate Student |
| Affiliation |
Government dental college and hospital |
| Address |
Department of Periodontics, Room no.4,
Floor -2,
Government dental college and hospital, Vijayawada
Krishna ANDHRA PRADESH 520008 India |
| Phone |
9010546592 |
| Fax |
|
| Email |
drravikumarsaka@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Lahari Buggapati |
| Designation |
Associate Professor |
| Affiliation |
Government dental college and hospital |
| Address |
Department of Periodontics, Room no.4, Floor -2, Government dental college and hospital, Vijayawada
Krishna ANDHRA PRADESH 520008 India |
| Phone |
8142098984 |
| Fax |
|
| Email |
drlaharimds@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrRavi Kumar Saka |
| Designation |
Post graduate Student |
| Affiliation |
Government dental college and hospital |
| Address |
Department of Periodontics, Room no.4,
Floor -2,
Government dental college and hospital, Vijayawada
Krishna ANDHRA PRADESH 520008 India |
| Phone |
9010546592 |
| Fax |
|
| Email |
drravikumarsaka@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Vivekanand Kattimani, Head of the Department, Department of Clinical Research, Sibar Institute of Dental Sciences ,Guntur 522509, Andhra Pradesh, India |
| Government Dental College and Hospital, Vijayawada - 520004, Krishna district, Andhra Pradesh, India |
|
|
Primary Sponsor
|
| Name |
DrRavi Kumar Saka |
| Address |
Post graduate student, Department of Periodontics, Government Dental College and Hospital, Vijayawada - 520004, Krishna district,
Andhra Pradesh, India
|
| 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 Ravi Kumar Saka |
Government Dental College and Hospital |
Room no.-4, Floor -2,Department of Periodontics, Government Dental College and Hospital, Vijayawada Krishna ANDHRA PRADESH |
9010546592
drravikumarsaka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Peridontal Flap Surgery and Egg shell derived nanohydroxyapatite graft |
During the periodontal flap surgery the Egg shell derived nanohydroxyapaptite graft material will be placed in the intrabony defect immediately |
| Comparator Agent |
Periodontal Flap Surgery |
Periodontal flap surgery will be done with no graft material |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with age between 25 to 55 years.
2. Patient with periodontitis having intrabony defects.
3. Probing pocket probing depth ≥6mm. Two and three wall bony defects.
4. Systemically healthy compliant patients who had not received any periodontal treatment in the past 6 months.
|
|
| ExclusionCriteria |
| Details |
1. Patients who are systemically ill
2. Patients having immune system related problems
3. Patients having bone pathologies |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Alveolar bone regeneration in intrabony defect |
1. Alveolar bone regeneration in intrabony defect - Baseline, 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Probing pocket depth & relative attachment level |
Probing pocket depth & relative attachment level at 3months, 6month, 9 months |
|
|
Target Sample Size
|
Total Sample Size="28" Sample Size from India="28"
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)
|
21/06/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Hydroxyapatite [HA] is apatite calcium phosphate. HA shows highest level of bioactivity and forms a quick bond with bone. The eggshell is a ubiquitous source of HA, and nanotechnology has made it possible to elicit a veritable biomaterial1.EnHA meets the required criteria and properties of an ideal graft substitute with its inherent porosity and osteotransconductivity. Lack of disease transfer risks, biocompatibility, and ease of use makes EnHA a viable source as regenerative material. EnHA is hydrophilic in nature, absorbed by body fluids and blood, so that handling becomes easy for placing it in the surgical site.The clinical studies have demonstrated the significant role of conventional graft materials in bone regeneration in periodontal intrabony defects. But to the best of our knowledge, there are limited studies on eggshell derived nanohydroxyapatite (EnHA) as a graft material in an intrabony defect. Hence the present study is planned to evaluate the effectiveness of EnHA graft in regeneration of bone in periodontal intra bony defects using a precise technology such as Cone Beam Computed Tomography [CBCT]. |