NCT06811818

Brief Summary

This is a randomized control trial to compare masticatory performance in complete dentures with bilateral balanced occlusion or lingualized occlusion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
Last Updated

February 6, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

January 19, 2025

Last Update Submit

February 2, 2025

Conditions

Keywords

Masticatory performance , Bilateral balanced occlusion , Lingualized occlusion

Outcome Measures

Primary Outcomes (1)

  • Masticatory Efficiency in Complete Dentures by weighing the dried chewed material through electric balance

    The chewed material that has been sieved through 10-mesh sieve and dried through blotting paper for 30 minutes weighted using an electronic balance with a precision of 0.01 grams . Statistical analysis performed to evaluate masticatory efficiency based on the mean weight of chewed peanuts.

    upto 24 weeks

Study Arms (2)

complete denture with bilateral balanced occlusion

ACTIVE COMPARATOR

complete denture with bilateral balanced occlusion

Other: complete denture with bilateral balanced occlusion

complete denture with lingualized occlusion

ACTIVE COMPARATOR

complete denture with lingualized occlusion

Other: complete denture with lingualized occlusion

Interventions

Participants in this group will be given complete dentures with bilateral balanced occlusion

complete denture with bilateral balanced occlusion

Participants in this group will be given complete dentures with lingualized occlusion

complete denture with lingualized occlusion

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants aged 45-65 years.
  • Both genders included.
  • Edentulous patients requiring complete denture.
  • Patients willing to participate in the study .

You may not qualify if:

  • Participants not willing to participate in the study.
  • Participants with systemic disease .
  • Participants with neuromuscular disorders .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armed Forces Institute Of Dentistry

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Interventions

Denture, Complete

Intervention Hierarchy (Ancestors)

DenturesDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Study Officials

  • Seema Khattak, BDS

    Armed Forces Institute of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Seema Khattak , Principal Investigator and Resident Prosthodontics

Study Record Dates

First Submitted

January 19, 2025

First Posted

February 6, 2025

Study Start

July 1, 2024

Primary Completion

December 30, 2024

Study Completion

December 31, 2024

Last Updated

February 6, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations