| CTRI Number |
CTRI/2024/12/078221 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparison in brain activity and tactile sensibility after prosthodontic rehabilitation |
|
Scientific Title of Study
|
Active Tactile Sensibility and Brain Activity evaluation in partially edentulous mouth with implant-supported prosthesis. An in-vivo split mouth 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 |
Dr Pallavi Kendre |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Room number 4, Unit of Prosthodontics and Crown and Bridge, Faculty of Dental Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7977208451 |
| Fax |
|
| Email |
drpallavikendre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Bhatnagar |
| Designation |
Professor and Guide |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Room number 4, Unit of Prosthodontics and Crown and Bridge, Faculty of Dental Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7080866678 |
| Fax |
|
| Email |
atuldent@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Atul Bhatnagar |
| Designation |
Professor and Guide |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Room number 4, Unit of Prosthodontics and Crown and Bridge, Faculty of Dental Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7080866678 |
| Fax |
|
| Email |
atuldent@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh 221005 |
|
|
Primary Sponsor
|
| Name |
Dr Pallavi Kendre |
| Address |
Room number 4, Unit of Prosthodontics and Crown and Bridge, Faculty of Dental Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh 221005 |
| 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 Pallavi Kendre |
Institute of Medical Sciences |
Room number 4, Unit of Prosthodontics, Faculty of Dental Sciences, Institute Of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH |
7977208451
drpallavikendre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BANARAS HINDU UNIVERSITY INSTITUTE OF MEDICAL SCIENCES INSTITUTIONAL ETHICS COMMITTEE |
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 |
Active Tactile Sensibility |
Active tactile sensibility will be evaluated after placement of implant supported prosthesis (3months after implant placement) |
| Comparator Agent |
Active Tactile Sensibility |
Active tactile sensibility will be evaluated prior to single implant placement |
| Intervention |
Electroencephalogram |
EEG will be evaluated after placement of single implant supported prosthesis (3 months after implant placement) |
| Comparator Agent |
Electroencephalogram |
Electroencephalogram will be evaluated prior to single implant placement |
| Intervention |
Functional magnetic resonance imaging |
Functional magnetic resonance imaging will be evaluated after placement of implant supported prosthesis (3months after implant placement) |
| Comparator Agent |
Functional magnetic resonance imaging |
Functional magnetic resonance imaging will be evaluated prior to single implant placement |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with either missing a single anterior or posterior tooth, with an intact opposing tooth of natural dentition.
2) Patients with good oral hygiene and healthy periodontal status.
3) Patients who were willing to report for follow-up visits.
4) Patients with adequate hearing ability and those who did not use or require any hearing aid.
5) No acute infection is present.
6) Informed and signed consent.
|
|
| ExclusionCriteria |
| Details |
1) Patients with history of
a)Any chronic illness (any systemic disease).
b) Tobacco intake (smoke or smokeless) or any other substance abuse.
c)Temporomandibular disorders.
d)Any parafunctional habits like bruxism, tongue thrusting, and clenching of teeth.
e) Irradiation in the head and neck area.
2) Orthodontic treatment.
3) Endodontic treatment in opposing intact tooth of natural dentition.
4) Patients with poor oral hygiene and suffering with periodontitis
5) Pregnant patients.
6)Active chemotherapy or active radiotherapy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in tactile sensibility and brain activity |
Before and after dental implant placement at about 3 months over a period of 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any changes in cognitive function |
2 years |
|
|
Target Sample Size
|
Total Sample Size="19"
Sample Size from India="19"
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)
|
01/01/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a split-mouth study focussing on evaluation of osseoperception and changes in brain activity in partially edentulous patients rehabilitated with single implant-supported prostheses. It will employ functional MRI (fMRI), Electroencephalogram (EEG), and Active Tactile Sensibility (ATS) to analyze spatial and temporal brain function and tactile sensitivity. The methodology includes psychophysical and neurophysiological assessments before and after implant placement, with periodic evaluations over time. The findings aim to explore neuroplasticity and mechanoreception, by contributing to advancements in oral neuroscience and prosthodontics. |