Clinical trial NCT05468983: BioHPP Hybrid Prosthesis Versus BioHPP Bar Implant Supported and Retained Overdenture Rehabilitating Edentulous Mandible
Official title: BioHPP Hybrid Prosthesis Versus BioHPP Bar Implant Supported and Retained Overdenture Rehabilitating Edentulous Mandible
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Marginal Bone Loss
Patient Satisfaction
Keywords: BioHpp
hybrid prosthesis
overdenture
bone loss
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 14
Sex: MALE
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: bone height change around implants
timeFrame: 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:
measure: patient satisfactions
timeFrame: 6 months and 18 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Prosthodontics Department Faculty of Dentistry
state: Ain Shames University
Study officials:
affiliation: faculty of dentistry ,Ain Shames University
name: Mahmoud H El Afandy, prof
role: STUDY_DIRECTOR
affiliation: faculty of dentistry ,Ain Shames University
name: Magda H Mohamed, lectu
role: PRINCIPAL_INVESTIGATOR
References: