| CTRI Number |
CTRI/2024/07/069894 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare overall clinical performance and patient satisfaction of two different types of denture materials (acetal resin and cobalt chromium) as a removable treatment option for missing teeth |
|
Scientific Title of Study
|
A randomized clinical trial on the comparison of clinical performance and patient satisfaction of partial dentures made from acetal resin and cast cobalt chromium |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meenapriya M |
| Designation |
Post graduate Student |
| Affiliation |
Faculty of Dental Sciences, Ramaiah University of Applied Sciences |
| Address |
Department of Prosthodontics, Room no 4, 1st floor, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, NEW BEL Road
Bangalore
KARNATAKA
560054
India |
| Phone |
8148769512 |
| Fax |
|
| Email |
meenapriyam99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravishankar K |
| Designation |
Professor |
| Affiliation |
Faculty of Dental Sciences, Ramaiah University of Applied Sciences |
| Address |
Department of Prosthodontics, Room no 4, 1st floor, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, NEW BEL Road
Bangalore
KARNATAKA
560054
India |
| Phone |
9886056303 |
| Fax |
|
| Email |
ravishankar.pr.ds@msruas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenapriya M |
| Designation |
Post graduate Student |
| Affiliation |
Faculty of Dental Sciences, Ramaiah University of Applied Sciences |
| Address |
Department of Prosthodontics, Room no 4, 1st floor, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, NEW BEL Road
KARNATAKA
560054
India |
| Phone |
8148769512 |
| Fax |
|
| Email |
meenapriyam99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prosthodontics, Room no 4, 1st floor, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar, Bangalore, Karnataka, India, Pincode - 560054 |
|
|
Primary Sponsor
|
| Name |
Dr Meenapriya M |
| Address |
Faculty of Dental Sciences, Ramaiah University of Applied Sciences, NEW BEL Road, Bengaluru, Karnataka, 560054 |
| 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 Meenapriya M |
Ramaiah Dental Hospital |
Department of Prosthodontics, Room no 4, 1st floor, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar
Bangalore
KARNATAKA |
8148769512
meenapriyam99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee for Human Trials Approval certificate, MS Ramaiah University of Applied Sciences |
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 |
| Intervention |
Acetal resin partial denture
(commercial name - biodentaplast) |
Patients with partially edentulous kennedys class 1 and 2 conditions will be rehabilitated with this dentures and evaluated for the parameters immediately and after 6 months of insertion |
| Comparator Agent |
Cast partial denture (cobalt chromium) |
Patients with partially edentulous Kennedys class 1 and 2 conditions will be subjected to conventional cast partial denture and evaluated for the parameters immediately and after 6 months of insertion.
The results of this will be compared with that of the intervention group. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Partially edentulous patients with Kennedy’s class 1 and class 2.
2. Partial edentulism in relation to maxilla or mandible.
3. Patients aged between 35 and 70 years.
4. Both male and female patients.
5. Patients who are willing to undergo either of metal or acetal resin partial denture.
6. Patients who can come for a follow up after 6 months
7. Good oral hygiene
8. Healthy, firm and resilient mucosa
9. Well-formed healed partially edentulous arches |
|
| ExclusionCriteria |
| Details |
1. Patients with uncontrolled systemic diseases
2. Patients with neuromuscular disorders
3. Patients with parafunctional habits
4. Heavy smokers (more than 20 cigarettes per day)
5. Any inflammation or ulceration of mucosa and exostosis
6. Patients who are allergic to metal
7. Severely resorbed, knife edged ridge in the area of edentulism
8. Periodontitis stage 3 and 4 |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the clinical performance (periodontal health including pocket depth, clinical attachment loss, gingival index, tooth mobility and plaque index; radiographic evaluation of abutment teeth) for partial dentures made from acetal resin and
cobalt-chromium at baseline and at 6 months post insertion. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the patient satisfaction for partial dentures made from acetal resin and cobalt-chromium at baseline and at 6 months post insertion. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The rise in the number of partially edentulous patients, has resulted in a greater need for prosthetic rehabilitations. While there are several available options for fixed prosthetic treatments, such as FPDs and implants, certain clinical situations necessitate the use of removable partial dentures, which still present benefits when compared to the fixed treatment options. Additionally, the escalating expenses associated with fixed prosthesis have contributed to an increased demand for partial dentures. Edentulism due to trauma, caries or periodontal disease affects the masticatory function and phonetics of the patient. Along with these, another factor to be concerned in the current era is aesthetics. In aesthetic zones, the conventional or commonly used metal clasps and dentures pose disadvantages. In addition, adverse tissue reactions can occur due to the release of toxic ions from metal cast partial dentures. (Saad, 2021) To overcome all the disadvantages of conventional metal partial dentures, thermoplastic resin has been recently introduced. One of which is polyoxymethylene (acetal) resin; advantages of which include superior aesthetics, patient comfort, high fatigue strength, low bacterial adhesion, minimal or no monomer and lower water sorption. (Abdelnabi, 2018) Nevertheless, despite its benefits, acetal resin does have certain limitations. One of the limitations is that the retentive force of the clasps made from acetal resin is reduced when compared to cobalt chromium. This is primarily due to its low modulus of elasticity. Additionally, the greater flexibility of acetal resin necessitates a bulkier design to compensate retention which creates pathway for plaque accumulation (Smitha, 2012). Despite reduced retentive force of the clasps made from acetal resin, it exhibits less or no deformation during prolonged use when compared with conventional cobalt-chromium clasps. (Taleb, 2013) Literatures supporting clinical performance and patient satisfaction of acetal resin dentures specifically in Kennedy’s class 1 and 2 situations with long term follow up is scarce. Though various invitro studies on the stress distribution, deformation, retentive ability is available, there are very less clinical studies on the efficacy of acetal resin partial dentures. Furthermore, there is a lack of literature on randomized clinical trials conducted on this subject. Aim of the study: To evaluate and compare the clinical performance and patient satisfaction of acetal resin and cobalt-chromium partial dentures over a period of 6 months. Objectives of the study: 1. To evaluate the clinical performance (periodontal health including pocket depth, clinical attachment loss, gingival index, tooth mobility and plaque index; radiographic evaluation of abutment teeth) for partial dentures made from acetal resin and cobalt-chromium at baseline and at 6 months post insertion. 2. To evaluate the patient satisfaction for partial dentures made from acetal resin and cobalt-chromium at baseline and at 6 months post insertion. 3. To compare the clinical performance and patient satisfaction for partial dentures made from acetal resin and cobalt-chromium at baseline and at 6 months post insertion. |