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

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.

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction; Marginal Bone Loss
• Intervention / Treatment: Procedure: surgical ( implants placement)

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ain Shames University
    • Cairo, Ain Shames University, Egypt, 11591
      • Prosthodontics Department Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfactions	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.	6 months and 18 months

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): May 21, 2018
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): February 20, 2022

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: bone loss; overdenture; BioHpp; hybrid prosthesis
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: 686

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No