Comparative Evaluation of Masticatory Efficiency of Implant Supported Overdenture

Sponsor
Al-Azhar University (Other)
Overall Status
Completed
CT.gov ID
NCT05877092
Collaborator
(none)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: implants with overdentures
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparative Evaluation of Masticatory Efficiency of Implant Supported Thermoplastic Versus Conventional Acrylic Resin Mandibular Overdenture With Bar/Clip Attachment
Actual Study Start Date :
Mar 1, 2022
Actual Primary Completion Date :
Dec 20, 2022
Actual Study Completion Date :
Jan 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Test of Masticatory Efficiency by using three different food categories [immediately after dentures were placed.]

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

  2. The Number of chewing cycle strokes up to the first sallow [immediately after dentures placed.]

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

  3. The Number of chewing cycle strokes until the mouth is free of food [immediately after dentures placed.]

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

  4. The number of swallows until the mouth is free of food [immediately after dentures placed.]

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

  5. Time (in seconds) until the mouth is free of food [immediately after dentures placed.]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 70 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Al-Azhar univeristy Cairo Egypt 11884

Sponsors and Collaborators

  • Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hamada Zaki Mahross Atia, Assistant Professor, Al-Azhar University
ClinicalTrials.gov Identifier:
NCT05877092
Other Study ID Numbers:
  • 903/2935
First Posted:
May 26, 2023
Last Update Posted:
May 26, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hamada Zaki Mahross Atia, Assistant Professor, Al-Azhar University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2023