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

NCT05468983 | Completed DMC

• 1 other identifier: 686
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Marginal Bone Loss; Patient Satisfaction

Keywords

BioHpp; hybrid prosthesis; overdenture; bone loss

Outcome Measures

Primary Outcomes (1)

• bone height change around implants

  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.

  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

Secondary Outcomes (1)

• patient satisfactions

  6 months and 18 months

Study Arms (2)

BioHpp hybrid prosthesis( fixed )

OTHER

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)

BioHpp bar supported and retained overdenture

OTHER

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)

Interventions

surgical ( implants placement) PROCEDURE

4 implants were placed interforamen of the mandibular arch by using the surgical guide

Also known as: Final prosthesis was constructed on the 4 implants

BioHpp bar supported and retained overdenture; BioHpp hybrid prosthesis( fixed )

Eligibility Criteria

• Age: 55 Years - 65 Years
• Gender Eligibility Details: All selected patients were healthy to minimize gender difference and to avoid the sex-related hormonal changes that accompany the menopausal and post-menopausal periods in females, which might affect the rate of alveolar ridge resorption
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• TMJ disorders.
• Radiotherapy or chemotherapy.
• Diabetes mellitus
• Uncooperative patients

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Prosthodontics Department Faculty of Dentistry

Cairo, Ain Shames University, 11591, Egypt

Location

MeSH Terms

Conditions

Patient Satisfaction; Bone Diseases, Metabolic

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mahmoud H El Afandy, prof

  faculty of dentistry ,Ain Shames University

  STUDY DIRECTOR

• Magda H Mohamed, lectu

  faculty of dentistry ,Ain Shames University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: July 21, 2022
• Study Start: May 21, 2018
• Primary Completion: December 20, 2021
• Study Completion: February 20, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Locations

EG (1)