| CTRI Number |
CTRI/2018/12/016590 [Registered on: 10/12/2018] Trial Registered Prospectively |
| Last Modified On: |
14/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To check if the mini implant is successful in improving comfort in the lower jaw of the patient |
|
Scientific Title of Study
|
Effectiveness of mini-dental implant supported mandibular overdenture on rehabilitaion of edentulous mandibular arch – an invivo study |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| U1111-1226-7024 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjum Afshan |
| Designation |
PG student Dept of Prosthodontics |
| Affiliation |
MS Ramaiah Dental College |
| Address |
MS Ramaiah Dental College,
New Bel Road
Room no 4, Dept of Prosthodontics
Bangalore
KARNATAKA
560094
India |
| Phone |
|
| Fax |
|
| Email |
anjumafshan.aa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Shankar |
| Designation |
Professor Dept of Prosthodontics |
| Affiliation |
Ramaiah Dental College |
| Address |
MS Ramaiah Dental College,
New Bel Road
Room no 4, Dept of Prosthodontics
Bangalore
KARNATAKA
560094
India |
| Phone |
|
| Fax |
|
| Email |
docravi76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Shankar |
| Designation |
Professor Dept of Prosthodontics |
| Affiliation |
Ramaiah Dental College |
| Address |
MS Ramaiah Dental College,
New Bel Road
Room no 4, Dept of Prosthodontics
KARNATAKA
560094
India |
| Phone |
|
| Fax |
|
| Email |
docravi76@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Anjum Afshan |
| Address |
Ramaiah Dental College
New Bel Road |
| 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 Anjum Afshan |
MS Ramaiah Dental College |
Dept Of Prosthodontics,
New Bel Road
Bangalore
KARNATAKA |
8050491851
anjumafshan.aa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee Human Trial |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients who are fit to give informed consent and not contraindicated for dental implants |
| Patients |
(1) ICD-10 Condition: Z00-Z13||Persons encountering health services for examinations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Delayed Loading |
after implant placement. wait for osseointegration then placement of denture |
| Comparator Agent |
Patient Satisfaction Questionnaire |
Before implant placement and comparing it after implant placement |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Completely edentulous patients wearing removable complete denture prosthesis for atleast 6 months
ï‚· Age group : 40-70 years
ï‚· Gender- both male and female
ï‚· Adequate bone width and height to place an implant of atleast 2.4mm diameter and 10 mm in length
ï‚· Able to give informed consent to participate in the study |
|
| ExclusionCriteria |
| Details |
Immune compromised ( on immune – steroid therapy)
ï‚· Need for any soft tissue or hard tissue augmentation procedures
ï‚· Osteoporosis
ï‚· Patients unwilling to provide informed consent
ï‚· Blood dyscrasias
ï‚· Undergone radiotherapy
ï‚· Medically compromised
ï‚· Bruxism |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mini Implants osseointegration |
3 months afer implant placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Valid change in questionnaire.
Improved patient satisfaction |
one week after denture placement over implant |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/12/2018 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
After Study Completion |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Completely edentulous patients frequently suffer from an inadequate retention and stability of their mandibular dentures. Thus, rehabilitation with conventional prostheses in case of edentulous lower jaws may create functional and psychological problems for the patients. However, atrophy of edentulous jaws and anatomic restrictions may limit the conventional implant placement or require additional surgical interventions. With MINI DENTAL IMPLANT taking the mainstage as retentive aid for an overdenture and having favorable prosthetic outcome, augment their use in definitive prosthodontics. |