BioHPP Hybrid Prosthesis Versus BioHPP Bar Implant Supported and Retained Overdenture Rehabilitating Edentulous Mandible

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT05468983
Collaborator
(none)
14
1
2
45
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Study Details

Study Description

Brief Summary

The biggest challenge of oral rehabilitation is the replacement of lost structures and the restoration of their function and esthetics, focusing on matching a healthy tooth.

Traditional complete dentures, implant (retained, supported) overdentures, and complete implant-supported fixed prostheses are all alternatives to the rehabilitation of the mandibular arch.

The aim of this study was to compare BioHPP used as a skeletal substructure for hybrid (implant fixed, detachable) prostheses versus BioHPP bar supporting and retaining by using radiographic tracing to the marginal bone height changes around the implants, patient satisfaction can be improved.

Condition or Disease Intervention/Treatment Phase
  • Procedure: surgical ( implants placement)
N/A

Detailed Description

Fourteen completely edentulous male patients were selected from the out-patient clinic, Prosthodontic Department, Faculty of Dentistry, Ain Shams University, according to certain criteria, and they were randomly allocated into two equal groups: group I: the seven patients were rehabilitated by the BioHpp hybrid prosthesis supported on four inter-foraminal implants; group II: While in group II, seven patients were rehabilitated by the BioHpp bar supported and retained overdenture.

The upper and lower complete dentures were constructed following conventional methods, and the surgical guide was constructed according to dual-scan CBCT.

the four parallel inter-foraminal implants were inserted in the mandible for each patient through used the surgical guide ( flapless technique ) After three months from the first surgery, the final prosthesis was constructed.

For Group I; BioHpp fixed hybrid prosthesis, for Group II; BioHpp bar implant-supported and retained complete overdentures were created using digital workflow CAD/CAM.

The crestal bone height loss was evaluated after six, twelve, and eighteen months from implant loading by using digital preapical radiography. Also, the patient's subjective evaluations by using a questionnaire based on the visual analog scale including five points (low dissatisfied, dissatisfied, fair, satisfied, highly satisfied) were evaluated for speech, chewing, comfort aesthetic, oral hygiene, and general satisfaction.

A comparison between groups I and II was performed by using the Chi-square test, which revealed in the results that group II was significantly lower than group I at all intervals in the mesial and distal surfaces of anterior and posterior implants. Also, the results of the patient satisfaction revealed that, after 6 months, there was an insignificant difference between them as P > 0.05 in all except oral hygiene, as satisfaction was significantly higher in group II than in group I. While, after 12 months, there was an insignificant difference between them all (P > 0.05).

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
to compare BioHPP used as a skeletal substructure for hybrid (implant fixed, detachable) prostheses versus BioHPP bar supporting and retaining by using radiographic tracing to the marginal bone height changes around the implants, patient satisfaction can be improved.to compare BioHPP used as a skeletal substructure for hybrid (implant fixed, detachable) prostheses versus BioHPP bar supporting and retaining by using radiographic tracing to the marginal bone height changes around the implants, patient satisfaction can be improved.
Masking:
Single (Investigator)
Masking Description:
All the Selected patients were rehabilitated with the upper and the lower complete denture then was divided by computer randomization "using random allocation software: into two equal groups
Primary Purpose:
Other
Official Title:
BioHPP Hybrid Prosthesis Versus BioHPP Bar Implant Supported and Retained Overdenture Rehabilitating Edentulous Mandible
Actual Study Start Date :
May 21, 2018
Actual Primary Completion Date :
Dec 20, 2021
Actual Study Completion Date :
Feb 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: BioHpp hybrid prosthesis( fixed )

4 implants were placed in the mandibular arch by a surgical guide, after 3 months the final prosthesis was constructed by using a digital workflow( CAD-CAM )

Procedure: surgical ( implants placement)
4 implants were placed interforamen of the mandibular arch by using the surgical guide
Other Names:
  • Final prosthesis was constructed on the 4 implants
  • Other: BioHpp bar supported and retained overdenture

    4 implants were placed in the mandibular arch by a surgical guide, after 3 months the final prosthesis was constructed by using a digital workflow( CAD-CAM )

    Procedure: surgical ( implants placement)
    4 implants were placed interforamen of the mandibular arch by using the surgical guide
    Other Names:
  • Final prosthesis was constructed on the 4 implants
  • Outcome Measures

    Primary Outcome Measures

    1. bone height change around implants [from insertion ( base line) to 6 months ) , from 6 months to 12 months ,from 12 months to 18 months , from insertion to 12 months, from insertion to 18 months]

      The bone loss measurements were taken using a digital preapical radiograph as follows: Two horizontal lines were drawn at the alveolar bone crest and the implant apex; the software then automatically displays the measurements in millimeters between the two lines on the screen. Subtraction was used to compute the difference in bone height. The mean of the mesial and distal readings was calculated. The software then displays the measurements in millimeters between the two lines on the screen. At each follow-up visit, the values of linear measurements were recorded in the patient's chart, and the mean value of bone height change was calculated using this data.

    Secondary Outcome Measures

    1. patient satisfactions [6 months and 18 months]

      Patient satisfaction was evaluated using a questionnaire based on the visual analog scale (VAS). Patients were asked to mark their answers (amount of satisfaction). The questionnaire was given to the patients in Arabic.Six factors were rated on a 1 to 5 scale (highly satisfied = 5; satisfied = 4; fair = 3; dissatisfied = 2; highly dissatisfied = 1). The sum of the five sub-scores was then calculated, ranging from 5 to 30 (best score = 30, worst score = 5). The low range of scores indicated low satisfaction.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 65 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1- sufficient inter arch distance. 2. good oral hygiene. 3. Enough bone volume in interforaminal region.

    Exclusion Criteria:
    1. TMJ disorders.

    2. Radiotherapy or chemotherapy.

    3. Diabetes mellitus

    4. Uncooperative patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prosthodontics Department Faculty of Dentistry Cairo Ain Shames University Egypt 11591

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Study Director: Mahmoud H El Afandy, prof, faculty of dentistry ,Ain Shames University
    • Principal Investigator: Magda H Mohamed, lectu, faculty of dentistry ,Ain Shames University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT05468983
    Other Study ID Numbers:
    • 686
    First Posted:
    Jul 21, 2022
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ain Shams University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 21, 2022