| CTRI Number |
CTRI/2021/03/032008 [Registered on: 15/03/2021] Trial Registered Prospectively |
| Last Modified On: |
25/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment for gum diseases using nanoparticles |
|
Scientific Title of Study
|
Efficacy of nanohydroxyapatite in Periodontal regeneration |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kalyanam Rashmi Durga |
| Designation |
Post graduate |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Room no-9
Department of Periodontology
JSS Dental College and Hospital
Bannimantap
Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9573638899 |
| Fax |
|
| Email |
rashmikalyanam10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra S |
| Designation |
Principal and Professor |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Room no-9
Department of Periodontology
JSS Dental College and Hospital
Bannimantap
Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9481872469 |
| Fax |
|
| Email |
drsravindra@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Kalyanam Rashmi Durga |
| Designation |
Post graduate |
| Affiliation |
JSS Dental college and Hospital |
| Address |
Room no-9
Department of Periodontology
JSS Dental College and Hospital
Bannimantap
Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9573638899 |
| Fax |
|
| Email |
rashmikalyanam10@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Academy of higher education and Research Institute |
|
|
Primary Sponsor
|
| Name |
JSS Academy of Higher Education and Research Institute |
| Address |
Bannimantap
Mysore
|
| 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 |
| Kalyanam Rashmi Durga |
JSS Dental College and Hospital |
Department of Periodontology
Room no 9
Bannimantap
Mysore
KARNATAKA |
9573638899
rashmikalyanam10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Dental college and Hospital institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injectable Nano hydroxyapatite bone graft |
Injectable Nano hydroxyapatite bone graft contains 35% of nano hydroxy apatite particles.
Quantity of bone graft used will be based on the size of the infrabony defect
|
| Intervention |
Injectable nanohydroxyapatite-nanochitosan bone graft |
Injectable Bone graft contains 35% nanohydroxyapatite and 35% nano chitosan particles.
Infrabony defects will be filled using this graft.
Quantity of graft used will be based on the size of the defect |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with more than 20 remaining teeth
Subjects with Chronic Periodontitis with Periodontal pocket depth greater than 5mm
Systemically healthy subjects with any vertical bone loss
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactating mothers, smokers
Allergic to chitosan/HAP
Compromised immune system
Undergone periodontal therapy in previous 6 months
Subjects taking medication that could interfere with soft tissue/bone healing.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Periodontal regeneration |
Baseline,3,months, 6 months,9months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce Periodontal pocket depth |
Baseline,3,months, 6 months,9months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
25/03/2021 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - will be visible to who ever is intrested
- For how long will this data be available start date provided 25-02-2021 and end date provided 25-02-2024?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Pre-surgical procedures: Patients fulfilling the inclusion criteria and have willingly given informed consent will be subjected to phase-1 therapy comprising of full-mouth scaling, root planing, and occlusal corrections if required. The subjects will be monitored for plaque control and tissue response and if found satisfactory will be prepared for surgery. Gingival index and plaque index will be recorded at baseline on the day of surgery. Intraoral radiographs with the grid will be taken by using paralleling technique to record osseous defect depth, Alveolar crest level. Method: Following local anesthesia with 2% Lignocaine, using block and infiltration techniques, intra-crevicular incisions will be given to reflect the full thickness mucoperiosteal flaps for defect access and debridement. The patients will be randomly divided into two study groups by computer alloted method GROUP-A {Test group}; Intra-bony defects will be filled with injectable nano hydroxyapatite-chitosan scaffold. GROUP-B {Control group}; Intrabony defects will be filled with nano-hydroxyapatite bone graft. The surgical flaps will be repositioned and sutured using 4-0 black silk to achieve primary closure. post-operative instructions will be given.
Post-surgical Evaluation: Patients will be recalled after 7 days for surgical removal Recall examinations will be scheduled at 3,6,9 months postoperatively and all the clinical parameters will be recorded Radiographic parameters(IOPAR with grid) and CBCT will be assessed at baseline and after 9 months Patients will be monitored periodically for their oral hygiene maintenance.
|