| CTRI Number |
CTRI/2021/03/032157 [Registered on: 19/03/2021] Trial Registered Prospectively |
| Last Modified On: |
18/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of function and psychological status between dental implant retained teeth versus tooth supported fixed teeth |
|
Scientific Title of Study
|
Comparative functional and psychological evaluation of osseointegrated dental implant retained prosthesis versus tooth supported fixed partial denture – 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 Bijay K Singh |
| Designation |
Professor |
| Affiliation |
Pacific dental college and hospital |
| Address |
Pacific dental college and hospital
Debari
Udaipur
Pacific dental college and hospital
Debari
Udaipur
Udaipur
RAJASTHAN
842001
India |
| Phone |
8209605284 |
| Fax |
|
| Email |
drvijay7in@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chirag J Chauhan |
| Designation |
Professor and guide |
| Affiliation |
Ahmedabad dental college and hospital |
| Address |
Bhadaj ranchodpura road
Ahmedabad Gujarat
Bhadaj ranchodpura road
Ahmedabad Gujarat
Ahmadabad
GUJARAT
382115
India |
| Phone |
9824165096 |
| Fax |
|
| Email |
drchauhan2007@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bijay K Singh |
| Designation |
Professor |
| Affiliation |
Pacific dental college and hospital |
| Address |
Pacific dental college and hospital
Debari
Udaipur
Pacific dental college and hospital
Debari
Udaipur
Udaipur
RAJASTHAN
842001
India |
| Phone |
8209605284 |
| Fax |
|
| Email |
drvijay7in@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Pacific dental college and hospital |
|
|
Primary Sponsor
|
| Name |
Pacific dental college and hospital |
| Address |
Pacific dental college and hospital
Debari
Udaipur
Rajasthan |
| 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 Bijay K Singh |
Pacific dental college and hospital |
Department of Prosthodontics
Pacific dental college and hospital
Debari
Udaipur
Udaipur
RAJASTHAN |
8209605284
drvijay7in@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PACIFIC DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dental implants |
Titanium dental implant manufactured by Alpha-Bio Tec,
Tel Aviv, Israel |
| Intervention |
Fixed partial denture prosthesis |
Teeth will be prepared and fixed denture prosthesis will be cemented to all the individuals in the study group by the primary investigator |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.No systemic contraindications for oral-surgical interventions.
2.Partially-edentulous-sites in the maxillary/mandibular-posterior-regions (Kennedy Class I, class II and Class III).
3.Presence of adequate-bone-width precluding the need for bone-augmentation-procedures.
4.Approximately similar bone height at the implant sites, which might allow for the placement of implants with similar height and diameter.
5.Occlusal scheme allowing for the establishment of bilateral balanced-occlusion contacts.
|
|
| ExclusionCriteria |
| Details |
1.Patients with anterior missing teeth.
2.Patients with inadequate bone support.
3.Patients with poor abutment.
4.Patient unwilling/unavailable for follow up visits.
|
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of masticatory efficiency of the two different types of missing teeth replacement modalities. |
2YEARS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| evaluation of the associated psychosocial status with the two treatment modalities |
2 years |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
21/03/2021 |
| 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
|
NOT YET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drvijay7in@yahoo.com].
- For how long will this data be available start date provided 04-03-2021 and end date provided 04-03-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
|
The past decade has seen tremendous advancements in dental technologies, techniques and applications.
The treatment of patients who have suffered tooth loss has always posed many problems in dental care. Removable prosthesis cannot restore function completely and often result in discomfort and mouth ulcers. Rehabilitation of tooth loss with fixed prosthesis has helped dentists to overcome this drawback and thus a lot of research is being put in this direction. Tooth loss is frequently associated functional disability, psychological distress and loss of self esteem. Treatments with fixed prosthesis have been able to restore function, comfort and esthetics. Patient satisfaction is a complex and multi dimensional phenomenon much of which remains unclear, studies to investigate patient satisfaction in different countries have concluded that patient satisfaction with fixed partial denture (FPD) was very high. But in recent times with advancements in implants there has been a paradigm shift from FPD to implants. The aim of this prospective clinical trial will be to compare and evaluate the effectiveness of two treatment modalities- implant supported fixed prosthesis and fixed partial dentures, on the basis of their functional and psychological satisfaction to the patients. | |