| CTRI Number |
CTRI/2017/09/009780 [Registered on: 14/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
13/03/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Better treatment option - Implant supported or tooth supported restorations |
|
Scientific Title of Study
|
Outcome of oral health related quality of life in patients treated with implant supported and tooth supported restorations |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonam Gupta |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Dental Sciences, Manipal, Karnataka |
| Address |
Room number 5, Second Floor, Department of Prosthodontics, Manipal College of Dental Sciences, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9902351346 |
| Fax |
|
| Email |
sonam.gupta10889@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhanasekar Balakrishnan |
| Designation |
Head and Professor, Department of Prosthodontics |
| Affiliation |
Manipal College of Dental Sciences, Manipal, Karnataka |
| Address |
Room number 5, Second Floor, Department of Prosthodontics, Manipal College of Dental Sciences, Manipal
Room number 5, Second Floor, Department of Prosthodontics, Manipal College of Dental Sciences, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9742444184 |
| Fax |
|
| Email |
dhanasekar.b@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhanasekar Balakrishnan |
| Designation |
Head and Professor, Department of Prosthodontics |
| Affiliation |
Manipal College of Dental Sciences, Manipal, Karnataka |
| Address |
Room number 5, Second Floor, Department of Prosthodontics, Manipal College of Dental Sciences, Manipal
Room number 5, Second Floor, Department of Prosthodontics, Manipal College of Dental Sciences, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9742444184 |
| Fax |
|
| Email |
dhanasekar.b@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self funded |
| Address |
Manipal, Karnataka-576104 |
| Type of Sponsor |
Other [] |
|
|
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 Sonam Gupta |
Manipal College of Dental Sciences, Manipal |
Manipal-576104
Udupi
KARNATAKA |
9902351346
sonam.gupta10889@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC_KH Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient with partially edentulous upper and lower arches |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects above 18 years of age
2. Subjects who have single or multiple missing teeth and wants treatment for the same |
|
| ExclusionCriteria |
| Details |
1. Subjects with systemic conditions like uncontrolled diabetes and hypertension
2. Subjects undergoing medication for psychological disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the change in the quality of oral health status among individuals undergoing prosthetic rehabilitation with fixed prosthesis and implant prosthesis |
T1- Before rehabilitation
T2- After rehabilitation
T3- After 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Impaired oral health related quality of life could be prevented via the prevention of tooth loss or replacement of teeth. |
T1- Before rehabilitation
T2- After rehabilitation
T3- After 6 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 4 |
|
Date of First Enrollment (India)
|
18/10/2016 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
1. John MT, Koepsell TD, Hujoel P, Miglioretti DL, LeResche L, Micheelis W. Demographic
factors, denture status and oral health-related quality of life. Community Dent Oral Epidemiol.
2004 Apr; 32(2): 125-32.
2. Wong MCM, McMillan AS. Tooth loss, denture wearing and oral health related quality of life
in elderly Chinese people. Community Dental Health, 2005; 22: 156-61.
3. Moynihan P and Petersen PE. Diet, nutrition and the prevention of dental diseases. Public
Health Nutrition 2004; 7(1A): 201–26. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aims:
1. To evaluate the change in the OHRQoL among individuals undergoing Fixed Partial Denture (FPD) prosthesis before and after treatment.
2. To evaluate the change in the OHRQoL among individuals undergoing implant supported prosthetic rehabilitation before and after treatment.
Method of collecting data:
Subjects visiting dental clinic undergoing treatment with implants and FPD prosthesis which meets the inclusion criteria of the study sample selected. An Oral Health Impact Profile (OHIP)questionnaire which is a tool for measuring OHRQoL will be given to the subject before and after treatment and change in OHRQoL will be assessed.
Inclusion criteria:
1. Subjects above 18 years of age
2. Subjects who have single or multiple missing teeth and wants treatment for the same
Exclusion criteria:
1. Subjects with systemic conditions like uncontrolled diabetes and hypertension
2. Subjects undergoing medication for psychological disorders
Sample size estimation:
This study will be evaluating the patients OHRQoL before and after treatment with implants and FPD prosthesis. The study population will be involving 48 healthy individuals in each group,
comprising total of 96 subjects.
Statistical analysis:
Appropriate statistical analysis will be done using repeated measure ANOVA analysis.
|