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CTRI Number  CTRI/2025/12/099186 [Registered on: 16/12/2025] Trial Registered Prospectively
Last Modified On: 15/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Do Different Denture Designs Influence Memory and Thinking? A One-Year Study in Denture Wearers 
Scientific Title of Study   Assessment of Changes in Cognitive Function and Cognitive Domain Among Complete Denture Wearers Using Different Occlusal Schemes: A One-Year 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Unni Pympallil 
Designation  Associate Professor 
Affiliation  Mahe Institute of Dental Sciences and Hospital 
Address  Room Number 102 Department of Prosthodontics Mahe Institute of Dental Sciences and Hospital Chalakkara Palloor Mahe UT of Puducherry

Mahe
PONDICHERRY
673310
India 
Phone  7829372178  
Fax    
Email  unnipympallil@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Unni Pympallil 
Designation  Associate Professor 
Affiliation  Mahe Institute of Dental Sciences and Hospital 
Address  Room Number 102 Department of Prosthodontics Mahe Institute of Dental Sciences and Hospital Chalakkara Palloor Mahe UT of Puducherry

Mahe
PONDICHERRY
673310
India 
Phone  7829372178  
Fax    
Email  unnipympallil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Unni Pympallil 
Designation  Associate Professor 
Affiliation  Mahe Institute of Dental Sciences and Hospital 
Address  Room Number 102 Department of Prosthodontics Mahe Institute of Dental Sciences and Hospital Chalakkara Palloor Mahe UT of Puducherry

Mahe
PONDICHERRY
673310
India 
Phone  7829372178  
Fax    
Email  unnipympallil@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Self Funded 
Address  Room Number 102 Department of Prosthodontics Mahe Institute of Dental Sciences and Hospital Chalakkara Palloor Mahe UT of Puducherry 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Unni Pympallil  Mahe Institute of Dental Sciences & Hospital  Room Number 102 Department of Prosthodontics Mahe Institute of Dental Sciences and Hospital Chalakkara, Palloor, Mahe, UT of Puducherry
Mahe
PONDICHERRY 		 7829372178

unnipympallil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee – Mahe Institute of Dental Sciences and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Edentulous Patients 
Patients  (1) ICD-10 Condition: K081||Complete loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Complete Denture  Complete Denture Fabricated based on three Different Occlusal Schemes. Its a comparative Study control is not there 
Intervention  Complete Denture   Complete Fabricated based on three Different a) Monoplane Occlusion b)Lingualized Occlusion c) Balanced Occlusion 
 
Inclusion Criteria  
Age From  55.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  • Individuals Aged 55 And Above Who Are Scheduled To Receive/Interested in
receiving Complete Dentures For The First Time who
• Individuals who are able to read and write in either English or Malayalam.
• Participants with no severe cognitive impairment at baseline, as assessed using a
standardized cognitive screening tool Montreal Cognitive Assessment (MoCA) with
a score between 20-24.
• Individuals willing to participate in follow-up assessments at 3 months, 6 months,
and 12 months post-denture insertion. 
 
ExclusionCriteria 
Details  • Individuals with a prior diagnosis of dementia, Alzheimer’s disease, or other
neurodegenerative disorders.
• Presence of significant psychiatric conditions (e.g., schizophrenia, severe depression)
that may interfere with cognitive assessment.
• History of stroke, traumatic brain injury, or neurological disorders that could affect
cognitive function.
• Use of medications known to significantly affect cognition (e.g., antipsychotics,
high-dose sedatives).
• Individuals with severe visual or auditory impairments that could hinder participation
in cognitive testing.
• Participants with temporomandibular joint disorders (TMD), chronic orofacial pain,
or significant oral lesions that could affect mastication and adaptation to complete
dentures.
• Lack of compliance or inability to attend scheduled follow-up visits for the duration
of the study. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Effect on Cognition and Cognitive Domain  0 Month, 3 Month, 6 Month, 12 Month 
 
Secondary Outcome  
Outcome  TimePoints 
Imporvemnet in Quality of Life  0 Month, 3 Month, 6 Month, 12 Months 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   12/01/2026 
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="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  

Study Design

This investigation will be a prospective observational study spanning one year, aimed at evaluating the effects of various occlusal schemes on cognitive function and specific cognitive domains among individuals who wear complete dentures. Participants will be assessed at intervals of 3 months, 6 months, and 12 months following the placement of their dentures to monitor cognitive changes over the study period.

 

Study Setting

The research will take place within the Department of Prosthodontics at [Institution Name], in partnership with the Department of Neurology/Psychology to facilitate the assessment of cognitive function. Prior to the commencement of participant recruitment, ethical approval will be secured from the Institutional Ethical Review Board.

 

Study Population

Participants will be sourced from the outpatient department of Prosthodontics and Crown & Bridge at Mahe Institute of Dental Sciences and Hospital.

 

Participant Grouping and Prosthodontic Intervention

 

 

Participants will be randomly allocated to receive complete dentures designed according to one of three occlusal schemes:

1.  Balanced Occlusion

2.  Lingualized Occlusion

3.  Monoplane Occlusion

The fabrication of complete dentures will adhere to established clinical and laboratory protocols. Adjustments will be performed post-placement to ensure both comfort and optimal functionality.

Assessment of Cognitive Function

Screening Procedure: The Montreal Cognitive Assessment (MoCA) will serve as the initial cognitive screening tool to identify and exclude participants exhibiting severe cognitive impairment.(37)

 

Evaluation of Cognitive Domains: The Addenbrooke’s Cognitive Examination (ACE) will be utilized to evaluate specific cognitive domains, which include: - Memory - Attention - Executive Function - Visuospatial Abilities - Verbal Fluency. (38)

 

Data Collection and Follow-Up

Cognitive function and assessments of specific cognitive domains will be conducted at the following intervals: - Baseline (prior to denture insertion) - 3 months following denture placement - 6 months following denture placement - 12 months following denture placement.

Data Analysis

1.     Descriptive statistics will summarize demographic variables and cognitive test scores.

2.     Repeated measures ANOVA or mixed-model analysis will compare cognitive function changes across different occlusal scheme groups over time.

3.     Post-hoc tests will identify specific cognitive domains affected by occlusal design.

4.     Multivariate regression analysis will assess potential confounders such as age, gender, and baseline cognitive status.

 

Expected Outcomes

This study aims to determine whether different occlusal schemes influence cognitive function and domain-specific cognitive performance in complete denture wearers over time. Findings could contribute to improved prosthodontic protocols that support both oral rehabilitation and cognitive health.

 

 
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