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Comparative Evaluation of Masticatory Efficiency of Implant Supported Overdenture

Primary Purpose

Mastication Disorder, Mandibular Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
implants with overdentures
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mastication Disorder focused on measuring Masticatory efficiency, thermoplastic base material, Bar attachment system

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: completely edentulous class I arch relationship 20-25MM inter-arch space free from any oral hard or soft tissue abnormality Exclusion Criteria: partially dentate patients abnormal arch class (class II or III) patients wit flabby tissue, acquired defects, or bony exccestosis.

Sites / Locations

  • Al-Azhar univeristy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

acrylic resin denture base

thermoplastic denture

Arm Description

complete overdenture constructed from heat cured acrylic resin for Group I

complete thermoplastic denture was constructed for Group II

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 6, 2023
Last Updated
May 25, 2023
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05877092
Brief Title
Comparative Evaluation of Masticatory Efficiency of Implant Supported Overdenture
Official Title
Comparative Evaluation of Masticatory Efficiency of Implant Supported Thermoplastic Versus Conventional Acrylic Resin Mandibular Overdenture With Bar/Clip Attachment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Based on inclusion and exclusion standards for implant selection, a twenty-four completely edentulous medically fit male patient aged 50-70 years were selected from the removable prosthodontics clinical, Faculty of Dental Medicine. The patient selection was determined through oral and dental examination, which revealed class I arch relationship with adequate 20-25MM inter-arch space and free from any oral hard or soft tissue abnormality that can interfere with the treatment. The selection was excluded all patients who do not satisfy these normal criteria. Written consent was obtained from each patients, detailing all surgical and prosthetic steps as well as the treatment's advantages and disadvantages. To obtain precise measurements of bone height and width at the implant site and accurately determine the size and type of the required implants, Cone Beam Computerized Tomography (CBCT) was performed, guided with a radiographic stent for each selected patient. According to the type of complete denture base material's construction, the twenty-four selected patients whose selected to participate in this trial, were grouped into two groups. Group I (n =12) patients with a heat polymerized acrylic resin complete mandibular overdenture HCG and In Group II (n =12) patients with a thermoplastic (polyamide) complete mandibular overdenture TPG, both groups were retained by a bar/clip attachment system. The masticatory efficiencies were examined using three different food categories in terms of the level of hardness, such as (apples, bananas, and carrots). Patients installed their mandibular overdentures while sitting upright. Each participant was then given assurances to help them rest and not be disturbed before eating the test food, which was cut into equal parts (1cm × 1cm). The following measures were recorded using a stopwatch: The Number of chewing cycle strokes up to the first sallow. The Number of chewing cycle strokes until the mouth is free of food. The number of swallows until the mouth is free of food. Time (in seconds) until the mouth is free of food. The data collected from the test groups, and a statistical evaluation conducted using the SPSS software program (IBM Company). The average, standard deviation, and lowest and highest values were also calculated for each group under consideration. A one-way ANOVA was also used to ascertain whether there were any significant differences in the averages of the different groups analyzed. Additionally, the Tukey test was used to evaluate whether averages differed significantly from each other at the specific probability level (P < 0.05).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mastication Disorder, Mandibular Dysfunction
Keywords
Masticatory efficiency, thermoplastic base material, Bar attachment system

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acrylic resin denture base
Arm Type
Active Comparator
Arm Description
complete overdenture constructed from heat cured acrylic resin for Group I
Arm Title
thermoplastic denture
Arm Type
Active Comparator
Arm Description
complete thermoplastic denture was constructed for Group II
Intervention Type
Device
Intervention Name(s)
implants with overdentures
Intervention Description
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.
Primary Outcome Measure Information:
Title
Test of Masticatory Efficiency by using three different food categories
Description
The masticatory efficiencies were examined using three different food categories in terms of the level of hardness, such as (apples, bananas, and carrots).
Time Frame
immediately after dentures were placed.
Title
The Number of chewing cycle strokes up to the first sallow
Description
by using a stopwatch, The Number of chewing cycle strokes up to the first sallow recorded
Time Frame
immediately after dentures placed.
Title
The Number of chewing cycle strokes until the mouth is free of food
Description
by using a stopwatch, The Number of chewing cycle strokes until the mouth is free of food recorded
Time Frame
immediately after dentures placed.
Title
The number of swallows until the mouth is free of food
Description
by using a stopwatch, The number of swallows until the mouth is free of food
Time Frame
immediately after dentures placed.
Title
Time (in seconds) until the mouth is free of food
Description
by using a stopwatch, Time (in seconds) until the mouth is free of food
Time Frame
immediately after dentures placed.

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Completely edentulous medically fit male patient aged 50-70 years
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: completely edentulous class I arch relationship 20-25MM inter-arch space free from any oral hard or soft tissue abnormality Exclusion Criteria: partially dentate patients abnormal arch class (class II or III) patients wit flabby tissue, acquired defects, or bony exccestosis.
Facility Information:
Facility Name
Al-Azhar univeristy
City
Cairo
ZIP/Postal Code
11884
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparative Evaluation of Masticatory Efficiency of Implant Supported Overdenture

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