NCT05877092

Brief Summary

the goal of this clinical trial To evaluate the effects of different base materials of mandibular implant supported overdenture with bar/clip attachment on masticatory efficacy. Twenty-four edentulous patients were selected to place two inter-foraminal mandibular implants with custom-made cast bar to retain overdentures made from two different base material and divided into two groups. The masticatory efficiency were tested using three different food categories (carrots, bananas, and apples) and measured by four parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

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

March 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

10 months

First QC Date

May 6, 2023

Last Update Submit

May 25, 2023

Conditions

Mastication DisorderMandibular Dysfunction

Keywords

Masticatory efficiencythermoplastic base materialBar attachment system

Outcome Measures

Primary Outcomes (5)

  • Test of Masticatory Efficiency by using three different food categories

    The masticatory efficiencies were examined using three different food categories in terms of the level of hardness, such as (apples, bananas, and carrots).

    immediately after dentures were placed.

  • The Number of chewing cycle strokes up to the first sallow

    by using a stopwatch, The Number of chewing cycle strokes up to the first sallow recorded

    immediately after dentures placed.

  • The Number of chewing cycle strokes until the mouth is free of food

    by using a stopwatch, The Number of chewing cycle strokes until the mouth is free of food recorded

    immediately after dentures placed.

  • The number of swallows until the mouth is free of food

    by using a stopwatch, The number of swallows until the mouth is free of food

    immediately after dentures placed.

  • Time (in seconds) until the mouth is free of food

    by using a stopwatch, Time (in seconds) until the mouth is free of food

    immediately after dentures placed.

Study Arms (2)

acrylic resin denture base

ACTIVE COMPARATOR

complete overdenture constructed from heat cured acrylic resin for Group I

Device: implants with overdentures

thermoplastic denture

ACTIVE COMPARATOR

complete thermoplastic denture was constructed for Group II

Device: implants with overdentures

Interventions

implants with overdenturesDEVICE

two implants with bar attachment placed in interforaminal of the mandible mandible of the participants, the patients were delivered conventional upper complete denture constructed from heat cured acrylic rein, but in implanted mandibular arch they were received complete overdenture constructed from heat cured acrylic resin for Group I, and complete thermoplastic denture was constructed for Group II.

acrylic resin denture basethermoplastic denture

Eligibility Criteria

Age50 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsCompletely edentulous medically fit male patient aged 50-70 years
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • completely edentulous
  • class I arch relationship
  • MM inter-arch space
  • free from any oral hard or soft tissue abnormality

You may not qualify if:

  • partially dentate patients
  • abnormal arch class (class II or III)
  • patients wit flabby tissue, acquired defects, or bony exccestosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar univeristy

Cairo, 11884, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Denture, Overlay

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

DenturesDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 6, 2023

First Posted

May 26, 2023

Study Start

March 1, 2022

Primary Completion

December 20, 2022

Study Completion

January 1, 2023

Last Updated

May 26, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)