| CTRI Number |
CTRI/2017/11/010579 [Registered on: 21/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
20/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Dental Implants |
|
Scientific Title of Study
|
comparative evaluation of soft and hard tissue changes induced by conventional and customized healing abutments in delayed placement of implants |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
shaik mohammad azruddin |
| Designation |
Post Graduate |
| Affiliation |
Govt Dental College and Hospital. |
| Address |
room no 317,
Dept of Periodontics,
Govt Dental College and Hospital,
Afzulgunj
Hyderabad
ANDHRA PRADESH
500012
India |
| Phone |
7207776098 |
| Fax |
|
| Email |
iamazruddin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P santha kumari |
| Designation |
Professor & Head of Department |
| Affiliation |
Govt Dental College and Hospital |
| Address |
room no 317
Dept of Periodontics
Govt Dental College and Hospital
Afzulgunj
room no 317
Dept of Periodontics
Govt Dental College and Hospital
Afzulgunj
Hyderabad
ANDHRA PRADESH
500012
India |
| Phone |
|
| Fax |
|
| Email |
santhaprathypaty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
shaik mohammad azruddin |
| Designation |
Post Graduate |
| Affiliation |
Govt Dental College and Hospital. |
| Address |
room no 317
Dept of Periodontics
Govt Dental College and Hospital
Afzulgunj
Hyderabad
ANDHRA PRADESH
500012
India |
| Phone |
7207776098 |
| Fax |
|
| Email |
iamazruddin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt dental college and hospital
Department of Periodontics
Afzulgunj
Hyderabad |
|
|
Primary Sponsor
|
| Name |
Govt Dental College Hospital |
| Address |
room no 317 government dental college and hospital afzulgunj hyderabad |
| Type of Sponsor |
Government medical college |
|
|
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 |
| shaik mohammad azruddin |
Govt dental college and hospital |
dept of periodontics
Govt dental college and hospital. hyderabad
Hyderabad
ANDHRA PRADESH |
7207776098
iamazruddin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GDCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
missing mandibular molars |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
myriad implants placement |
two piece impants delayed pllacement in posterior mandible |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
patients age 18-50 years old
|
|
| ExclusionCriteria |
| Details |
poor oral hygiene
presence of systemic diseases
abnormal ridge relationships
undergoing chemotherapy and radiation treatment in past six months
parafunctional habits |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| evaluation soft tissue changes |
3 months, 6 months, 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| evaluation soft tissue changes |
3months, 6 months, 9 months |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
04/06/2017 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
placement of two piece implants in the mandible and comparision of conventional and customised abutments |