Comparative Evaluation of Masticatory Efficiency of Implant Supported Overdenture

Comparative Evaluation of Masticatory Efficiency of Implant Supported Thermoplastic Versus Conventional Acrylic Resin Mandibular Overdenture With Bar/Clip Attachment

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.

Study Overview

• Status: Completed
• Conditions: Mastication Disorder; Mandibular Dysfunction
• Intervention / Treatment: Device: implants with overdentures

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).

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11884
    • Al-Azhar univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: acrylic resin denture base; complete overdenture constructed from heat cured acrylic resin for Group I	Device: implants with overdentures; 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.
Active Comparator: thermoplastic denture; complete thermoplastic denture was constructed for Group II	Device: implants with overdentures; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: May 6, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Masticatory efficiency; thermoplastic base material; Bar attachment system
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: 903/2935

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No