| CTRI Number |
CTRI/2021/04/033054 [Registered on: 23/04/2021] Trial Registered Prospectively |
| Last Modified On: |
22/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Computerized Occlusal Analysis of Conventional
Complete Denture and Single Implant Supported Mandibular Overdenture |
|
Scientific Title of Study
|
A Comparative Computerized Occlusal Analysis of Conventional
Complete Denture and Single Implant Supported Mandibular Overdenture |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anushi goel |
| Designation |
PG student |
| Affiliation |
AIIMS, New delhi |
| Address |
Second floor, Department of Prosthodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8168053814 |
| Fax |
|
| Email |
goyalanushi28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dheeraj Kumar Kohli |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Second floor, Department of Prosthodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9958661988 |
| Fax |
|
| Email |
drdheerajkoli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dheeraj Kumar Kohli |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Second floor, Department of Prosthodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9958661988 |
| Fax |
|
| Email |
drdheerajkoli@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi, Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
CDER |
| Address |
Second floor, Department of Prosthodontics, CDER, AIIMS 110049 |
| 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 |
| Dr Anushi Goel |
CDER AIIMS |
Second floor, Department of Prosthodontics Centre for Dental Education and Research
New Delhi
DELHI |
8168053814
goyalanushi28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K081||Complete loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional complete denture |
Measured percent bilateral force difference, max biting occlusal force and number of tooth contacts |
| Intervention |
single implant supported overdenture |
Measured percent bilateral force difference, max biting occlusal force and number of tooth contacts |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
74.00 Year(s) |
| Gender |
Both |
| Details |
â— Patients should be completely edentulous for at least six months, first-time denture wearer, and of age group between 50-74 years.
â— Patient having a minimum of 10mm bone length and width of 4.5mm in the mandibular symphyseal region.
â— The patient having an Angle class 1 jaw relationship.
â— Patients who give a positive written informed consent
|
|
| ExclusionCriteria |
| Details |
1.Any history of metabolic or systemic disease affecting the integration of implant or connective tissue health surrounding implant.
2.Any logistic or physical reason that could affect follow-up.
3.History of radiation therapy to head and neck.
4.History of drug or alcohol abuse.
5.Heavy smokers.
6.Unrealistic expectations.
7.Insufficient primary stability of implant.
8.History of temporomandibular disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate number of occlusal tooth contacts (tooth contact from canine to second molar area) in centric occlusion in single implant retained mandibular overdenture and conventional complete denture patient using computerized occlusal analysis system after 48hr, 3month and 6month of insertion of denture.
2 To evaluate percent maximum occlusal force
|
48hr, 3 month and 6 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate bilateral force difference (% difference between left chewing area and right chewing area from canine to second molar area)
2. To compare the number of occlusal tooth contacts, percent maximum occlusal force and bilateral force difference
|
48hr, 3month and 6 month |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2021 |
| 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="6"
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 - NO
|
|
Brief Summary
|
There has been no study comparing the
changes in maximum occlusal force and changes in the distribution of occlusal contact
after use of conventional complete denture and single implant-supported
overdenture. Hence this study has been designed. The null hypothesis
states that there will be statistically no significant difference in the number
of tooth contacts, percent bite force distribution, and percent bilateral force the difference in centric occlusion in cases with single implant-retained
mandibular overdenture or conventional
complete denture using computerized
occlusal analysis system after 48hr,
3month and 6month of insertion of the denture. |