| CTRI Number |
CTRI/2021/02/031175 [Registered on: 10/02/2021] Trial Registered Prospectively |
| Last Modified On: |
10/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Dentistry,Prosthodntics] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of chewing efficiency and patient satisfaction between complete denture prosthesis and mini implant supported over denture prosthesis |
|
Scientific Title of Study
|
A comparative evaluation of chewing efficiency, and patient satisfaction between conventional denture and 2 mini implant-supported mandibular overdenture: An in vivo study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hima Bindu Lanka |
| Designation |
PG student , Department of Prosthodontics |
| Affiliation |
Faculty of Dental Sciences, M S Ramaiah University of Applied Sciences |
| Address |
Faculty of Dental Sciences, M S Ramaiah University of Applied Sciences, Department of Prosthodontics, Room no 4, First floor, MSR nagar, New BEL road, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
7760123387 |
| Fax |
|
| Email |
hasini.hima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravishankar K |
| Designation |
Professor and Head, Department of Prosthodontics |
| Affiliation |
Faculty of Dental Sciences, M S Ramaiah University of Applied Sciences |
| Address |
Faculty of Dental Sciences, M S Ramaiah University of Applied Sciences, Department of Prosthodontics, Room no 4, First floor, MSR nagar, New BEL road, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9886056303 |
| Fax |
|
| Email |
docravi76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravishankar K |
| Designation |
Professor and Head, Department of Prosthodontics |
| Affiliation |
Faculty of Dental Sciences, M S Ramaiah University of Applied Sciences |
| Address |
Faculty of Dental Sciences, M S Ramaiah University of Applied Sciences, Department of Prosthodontics, Room no 4, First floor, MSR nagar, New BEL road, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9886056303 |
| Fax |
|
| Email |
docravi76@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hima Bindu Lanka ( individual)Faculty of Dental sciences , MS Ramaiah University of Applied Sciences, Department of Prosthodontics Room no 4,
First floor New bel road, Bangalore-560054 |
|
|
Primary Sponsor
|
| Name |
Faculty of Dental Sciences M S Ramaiah University of Applied Sciences |
| Address |
Faculty of Dental Sciences, M S Ramaiah University of Applied Sciences, MSR nagar, New BEL road, Bangalore |
| Type of Sponsor |
Other [Dental College 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 |
| Dr Hima Bindu Lanka |
Faculty of Dental Sciences |
Department of Prosthodontics
Room no 4, First floor
Faculty of Dental Sciences, M S Ramaiah University of Applied Sciences,New bel road,
Bangalore
Bangalore
KARNATAKA |
7760123387
hasini.hima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Univeristy Ethics Committee for Human Trials |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients who are healthy and not contra
indicated for dental implants, with no teeth in
their mouth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chewing Efficiency |
comparing between conventional complete denture and Mandibular mini dental implant supported overdenture |
| Comparator Agent |
Patient satisfaction |
with Conventional complete denture and with Mandibular mini dental implant supported overdenture |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Completely edentulous upper and lower arches , Adequate bone width and height to place an implant of at least 2.4mm diameter and 10mm in length |
|
| ExclusionCriteria |
| Details |
Patients with poor neuromuscular function, All patients who are contraindicated for undergoing surface EMG.( cardiac pacemakers , epilepsy), Undergone radiotherapy, Immune compromised ( on immune-steroid therapy), Need for any soft tissue or hard tissue augmentation, Bruxism, Any health conditions contraindicating implant placement (osteoporosis etc.)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| chewing efficiency |
4 weeks after insertion of conventional complete denture and then that of mini implant overdenture |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patient satisfaction |
4 weeks after insertion of prosthesis |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
12/02/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
after study completetion |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 (Chewing efficiency ) 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 main stage as retentive aid for an over denture and having favorable prosthetic outcome, augment their use in definitive prosthodontics. |