| CTRI Number |
CTRI/2020/01/023007 [Registered on: 27/01/2020] Trial Registered Retrospectively |
| Last Modified On: |
24/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of patient satisfaction and masticatory efficiency in complete dentures. |
|
Scientific Title of Study
|
COMPARISON OF PATIENT SATISFACTION AND MASTICATORY EFFICIENCY IN COMPLETE DENTURES FABRICATED BY CONVENTIONAL METHOD AND BIOFUNCTIONAL PROSTHETIC SYSTEM (BPS) - A RANDOMIZED CLINICAL TRIAL. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VIVEK SHANKAR P |
| Designation |
PG STUDENT |
| Affiliation |
SRM DENTAL COLLEGE AND HOSPITAL, RAMAPURAM. |
| Address |
DEPARTMENT OF PROSTHODONTICS,
PG SECTION,THIRD FLOOR,SRM DENTAL COLLEGE AND HOSPITAL, BHARATHI SALAI,RAMAPURAM, CHENNAI
Chennai TAMIL NADU 600089 India |
| Phone |
9094364641 |
| Fax |
|
| Email |
drvivekshankarmds@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
JAGDISH SK |
| Designation |
READER, DEPARTMENT OF PROSTHODONTICS |
| Affiliation |
SRM DENTAL COLLEGE AND HOSPITAL, RAMAPURAM. |
| Address |
DEPARTMENT OF PROSTHODONTICS,
THIRD FLOOR, SRM DENTAL COLLEGE AND HOSPITAL, BHARATHI SALAI, RAMAPURAM, CHENNAI
Chennai TAMIL NADU 600089 India |
| Phone |
9940163850 |
| Fax |
|
| Email |
jagdishsk@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
PETER JOHN |
| Designation |
READER, DEPARTMENT OF PROSTHODONTICS |
| Affiliation |
SRM DENTAL COLLEGE AND HOSPITAL, RAMAPURAM. |
| Address |
DEPARTMENT OF PROSTHODONTICS, THIRD FLOOR, SRM DENTL COLLEGE AND HOSPITAL, BHARATHI SALAI, RAMAPURAM,
CHENNAI
Chennai TAMIL NADU 600089 India |
| Phone |
9884444689 |
| Fax |
|
| Email |
drpeterjohn@gmail.com |
|
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Source of Monetary or Material Support
|
| VIVEK SHANKAR P, PG STUDENT, DEPARTMENT OF PROSTHODONTICS, PG SECTION, THIRD FLOOR, SRM DENTAL COLLEGE AND HOSPITAL, BHARATHI SALAI, RAMAPURAM, CHENNAI - 600089
|
|
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Primary Sponsor
|
| Name |
VIVEK SHANKAR P |
| Address |
DEPARTMENT OF PROSTHODONTICS,
THIRD FLOOR, SRM DENTAL COLLEGE AND HOSPITAL, BHARATHI SALAI, RAMAPURAM, CHENNAI |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vivek Shankar P |
SRM DENTAL COLLEGE AND HOSPITAL, RAMAPURAM |
Department of Prosthodontics, Third Floor,
PG Section, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu 600089 Thiruvallur TAMIL NADU |
9094364641
drvivekshankarmds@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, SRM Dental College, Ramapuram, Chennai. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
First time denture wearers, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Complete dentures fabricated by Biofunctional Prosthetic System (BPS). |
Biofunctional prosthetic system is a newer method of fabricationg complete denture. |
| Comparator Agent |
Complete dentures fabricated by conventional method. |
The regular method of fabricating complete denture. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy adult patient requiring a new set of complete dentures
2. Patients who are self motivated to wear dentures
3. Patients who are unaware of the different types and methods of fabrication of complete dentures / First time denture wearers.
4. Well formed residual alveolar ridges.
|
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| ExclusionCriteria |
| Details |
1. Patients wearing complete dentures who are unsatisfied despite no obvious defects in the existing denture.
2. Debilitating systemic diseases.
3. TMJ disorders.
4. Diseases of bones and joints.
5. Oral mucosal diseases.
6. Neurological diseases.
7. Psychiatric /Cognitive disorders.
8. Pathological changes in residual ridges.
9. Knife edge ridges.
10. Soft tissue abnormalities/Flabby ridges.
11. Thin mucosa/poor keratinisation.
12. Presence of tori/hard tissue undercuts.
13. Smoking, pan chewing.
14. Parafunctional habits.
15. Xerostomia/Hypersalivation.
16. Restricted tongue movement.
17. Palatal defects. (Soft palate/Hard palate)
18. Hyperactive mentalis muscle.
19. Very high frenal attachments. |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Patient satisfaction
Masticatory efficiency |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Frequency of denture adjustments |
1 week |
|
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Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2018 |
| Date of Study Completion (India) |
30/11/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Write up in process |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Clinical procedures:
Complete
dentures, both conventional and BPS, for the patients in test and control
groups will be done by a single operator. The operator will be postgraduate
student and will be supervised by an experienced clinical instructor. Dentures
in control group will be fabricated using conventional clinical procedures and
those in the test group will be fabricated using the BPS protocol. Both the
dentures will use the same teeth set (Ivoclair). Both the dentures will be processed
using the same resin (Ivoclair) by injection moulding technique. No logo will
be used on dentures fabricated using BPS protocol.
Data collection and analysis:
All patients
will be evaluated by a single evaluator, who will send the data to the data
collector/analyser. The data collector/analyser will be involved in grouping
the data and statistical evaluation.
Outcomes and outcome assessment:
The
primary outcomes will be patient satisfaction and masticatory efficiency. These
data will be collected 6 weeks after the denture insertion appointment. Patient
satisfaction will be evaluated by using Oral
Health‑Related
Quality of Life questionnaire, specifically designed for edentulous patients
(Oral Health Impact Profile for edentulous subjects) [OHIP‑EDENT].
Masticatory efficiency will be evaluated using wet sieve method of analysis. Secondary
outcome will be frequency of denture adjustments required after denture
insertion appointment and denture repair. Each patient will be followed up for
a period of 6 months.
Evaluation of
primary outcome which is patient satisfaction and masticatory efficiency is to
be done at the time of 6 weeks post insertion because the previous studies
suggest it to be optimal for review.
|