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

NCT ID: NCT05468983

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-21
• Study Completion Date: 2022-02-20

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.

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).

Conditions

Marginal Bone Loss; Patient Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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 )

Group Type: OTHER

surgical ( implants placement)

Intervention Type: PROCEDURE

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

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 )

Group Type: OTHER

surgical ( implants placement)

Intervention Type: PROCEDURE

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

Interventions

surgical ( implants placement)

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

Intervention Type: PROCEDURE

Other Intervention Names

Final prosthesis was constructed on the 4 implants

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahmoud H El Afandy, prof

Role: STUDY_DIRECTOR

faculty of dentistry ,Ain Shames University

Magda H Mohamed, lectu

Role: PRINCIPAL_INVESTIGATOR

faculty of dentistry ,Ain Shames University

Locations

Prosthodontics Department Faculty of Dentistry

Cairo, Ain Shames University, Egypt

Countries

Egypt

Other Identifiers

686

Identifier Type: -

Identifier Source: org_study_id