| CTRI Number |
CTRI/2024/07/070063 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To compare the brain activity and biting force in patients wearing complete dentures with fixed dentures. |
|
Scientific Title of Study
|
Correlation of neuroplastic activity and masticatory force in All-on-four and All-on-six implant supported prosthesis wearers - An in-vivo study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Stanzin Yangdol |
| Designation |
Junior Resident |
| Affiliation |
Faculty of dental sciences IMS BHU Varanasi |
| Address |
Room no 4, Unit of Prosthodontics, Faculty of Dental Sciences, IMS ,BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8899672620 |
| Fax |
|
| Email |
stanz.yandol850@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Romesh soni |
| Designation |
Professor |
| Affiliation |
Unit of prosthodontics, faculty of dental sciences IMS BHU |
| Address |
Room no:4,Unit of Prosthodontics, Faculty of Dental Sciences, IMS ,BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9616803332 |
| Fax |
|
| Email |
rsoni80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Romesh soni |
| Designation |
Professor |
| Affiliation |
Unit of prosthodontics, faculty of dental sciences IMS BHU |
| Address |
Room no: 4, Department of Prosthodontics, Faculty of Dental Sciences, IMS ,BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9616803332 |
| Fax |
|
| Email |
rsoni80@gmail.com |
|
|
Source of Monetary or Material Support
|
| self, Department of prosthodontics, Faculty of dental sciences , IMS BHU varanasi 221005 |
|
|
Primary Sponsor
|
| Name |
Self Faculty of dental sciences IMS BHU |
| Address |
Deparment of prosthodontics,faculty of dental sciences,BHU Varanasi , 221005 |
| Type of Sponsor |
Government medical college |
|
|
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 Stanzin yangdol |
Prosthodontics department BHU |
Second floor prosthodontics , department FDS IMS BHU
Varanasi
UTTAR PRADESH |
8899672620
ystanzin09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUT OF MEDICAL SCIENCES BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Implant supported prosthesis |
Implant supported prosthesis may include all on 4 implant supported fixed prosthesis, all on 6 implant supported prosthesis. the parameters for brain functional activity and masticatory force will be evaluate after 3 months |
| Comparator Agent |
Conventional complete denture |
conventional complate dentures in edentulous patients and then the parameters for brain activity and masticatory force will be evaluated after 1 month |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Completely edentulous arch or non-restorable remaining teeth.
2.Patient’s cooperation, motivation and good oral hygiene.
3.No acute infection should be present.
4.Without any history of temporomandibular joint disorders, pscychiatric disorders or on neuromodifying medication.
5.Signed informed consent
|
|
| ExclusionCriteria |
| Details |
1.Use of medical devices or the presence of conditions that would be dangerous in or incompatible with the MRI environment.
2.Use of over-the-counter medications within 3 days of the imaging session; presence of systemic, vascular, or central nervous system diseases.
3.Use of medications with known neuromotor effects, e.g., neuroleptics or antidepressants.
4.Unnecessary habits (smoking, presence of parafunctional habits)
5.Insufficient mouth opening to accommodate surgical instruments
6.Traumatic occlusion.
7.Non –compensated diabetes mellitus.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the cortical activity in functional magnetic resonance imaging is done |
At 1 month then at 4 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase in the masticatory force following prothetic rehabilitation after 1 months then after 4 months |
1 month then after 4 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 3 |
|
Date of First Enrollment (India)
|
16/07/2024 |
| 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="1"
Months="1"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A total of 10 patients
will be selected from the Out Patient Department (OPD) of Prosthodontic unit of
Faculty of Dental Sciences, Institute of Medical Sciences, BHU. Patient
selection will be made according to inclusion and exclusion criterion. After
taking history, patient will be evaluated clinically and radiographically. The
proposed treatment plan will be explained to the patient and necessary
investigation will be done after consent has been taken.
In group 1
patient (5 each), All-on -four implant treatment plan will be proposed , at first
conventional denture will be proposed. At first conventional denture will be
made then after 1 month functional MRI will be taken to see the brain activity
followed by assessing the masticatory force. After that four implant will be
placed each in maxillary and mandibular arch followed by waiting for 3 month to
osseointegrate. Prosthetic rehabilitation will be done after 3 month followed by again
taking the functional MRI to see the cortical changes and assessment of
masticatory force.
In group 2
patient (5 each), All on six implant treatment plan will proposed. Similar to
group 1 at first we will rehab with conventional denture then implant treatment,
6 implant in each arch. Then followed by functional MRI and masticatory force assessment
.Thus, we can make intragroup as well as intergroup assessment that is between
all on four and all on six treatment.
Functional MRI:It
is a non-invasive method to assess sensory function and visualisation of brain
activities through MRI. will
be carried out in the Radiodiagnosis Department of Sir Sunderlal Hospital,
IMS,BHU. Subjects will be asked to clench during the procedure while using
their respective complete denture prosthesis/implant supported prosthesis
during clenching activity. Subsequent to data collection ,a sensitivity
frequency(Fd%) will be applied, and the data thus obtained will be subjected to
statistical analysis.
Necessary
changes may be made in the methodology of proposed study, in its best interest |