| CTRI Number |
CTRI/2025/02/080848 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To compare the strength of bone screw during the tooth movement procedure with and without the addition bone graft(beta tricalcium phosphate ) |
|
Scientific Title of Study
|
Comparative evaluation of stability of orthodontic mini implants with and without beta-tri calcium phosphate-A randomized control split mouth 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 |
Dr SIJIN HS |
| Designation |
PG STUDENT,DEPARTMENT OF ORTHODONTICS |
| Affiliation |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH |
| Address |
DEPARTMENT OF ORTHODONTICS, ROOM NUMBER-6,PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH , GOLDEN HILLS ,VATTAPPARA ,VENKODE TRIVANDRUM
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9747333836 |
| Fax |
|
| Email |
hs.sijin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr DEEPU LEANDER |
| Designation |
PROFESSOR, DEPT OF ORTHODONTICS |
| Affiliation |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH |
| Address |
DEPARTMENT OF ORTHODONTICS,ROOM NUMBER-6,PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH , GOLDEN HILLS ,VATTAPPARA ,VENKODE TRIVANDRUM
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9847174072 |
| Fax |
|
| Email |
drdeepu.leander@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr DEEPU LEANDER |
| Designation |
PROFESSOR, DEPT OF ORTHODONTICS |
| Affiliation |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH |
| Address |
DEPARTMENT OF ORTHODONTICS ,ROOM NUMBER-6,PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH , GOLDEN HILLS ,VATTAPPARA ,VENKODE TRIVANDRUM
KERALA
695028
India |
| Phone |
9847174072 |
| Fax |
|
| Email |
drdeepu.leander@gmail.com |
|
|
Source of Monetary or Material Support
|
| PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH TRIVANDRUM ,KERALA ,INDIA ,PIN CODE 695028 |
|
|
Primary Sponsor
|
| Name |
Dr.SIJIN HS |
| Address |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH ,GOLDEN HILLS VATTAPPARA ,VENKODE,TRIVANDRUM 695028 |
| 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 SIJIN HS |
PMSCOLLEGE OF DENTAL SCIENCE AND RESEARCH DENTAL COLLEGE |
DEPARTMENT OF ORTHODONTICS , ROOM NUMBER -6,GOLDEN HILLS ,VATTAPPARA ,VENKODE TRIVANDRUM
Thiruvananthapuram
KERALA |
09747333836
hs.sijin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,PMS College of Dental Science and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
persons with malocclusion and requiring skeletal anchorage during fixed orthodontic treatment |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient reported in Department of Orthodontics and Dentofacial Orthopaedics who needs absolute anchorage for orthodontic correction with the age of between 18 to 35 years
2.According to ASA classification Class I and Class II patients will be included
|
|
| ExclusionCriteria |
| Details |
1. The patients who refuse to receive therapy with mini implants.
2. The patients who are uncooperative at orthodontic checkup appointments.
3. Patients with previous metal allergy.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess stability of miniimplants with and without beta tricalcium phosphate |
8 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess stability of miniimplants with and without beta tricalcium phosphate |
2 months |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
24/02/2025 |
| 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="0"
Months="2"
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
|
Beta tricalcium phosphate appears as very interesting bioactive material as it is easily resorbable. It can be prepared in various forms. Beta tri calcium phosphate is most used and potent synthetic bone graft substitute for replacement by the host bone occur early after implantation in both animal and human experiments. This study is to assess the stability of orthodontic mini implants with the use of beta tri calcium phosphate on one side of the arch and without beta tricalcium phosphate on the other side. |