BioHPP Hybrid Prosthesis Versus BioHPP Bar Implant Supported and Retained Overdenture Rehabilitating Edentulous Mandible (BioHPP)
Primary Purpose
Marginal Bone Loss, Patient Satisfaction
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
surgical ( implants placement)
Sponsored by
About this trial
This is an interventional other trial for Marginal Bone Loss focused on measuring BioHpp, hybrid prosthesis, overdenture, bone loss
Eligibility Criteria
Inclusion Criteria:
1- sufficient inter arch distance. 2. good oral hygiene. 3. Enough bone volume in interforaminal region.
Exclusion Criteria:
- TMJ disorders.
- Radiotherapy or chemotherapy.
- Diabetes mellitus
- Uncooperative patients
Sites / Locations
- Prosthodontics Department Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
BioHpp hybrid prosthesis( fixed )
BioHpp bar supported and retained overdenture
Arm Description
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 )
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 )
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05468983
Brief Title
BioHPP Hybrid Prosthesis Versus BioHPP Bar Implant Supported and Retained Overdenture Rehabilitating Edentulous Mandible
Acronym
BioHPP
Official Title
BioHPP Hybrid Prosthesis Versus BioHPP Bar Implant Supported and Retained Overdenture Rehabilitating Edentulous Mandible
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
February 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marginal Bone Loss, Patient Satisfaction
Keywords
BioHpp, hybrid prosthesis, overdenture, bone loss
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BioHpp hybrid prosthesis( fixed )
Arm Type
Other
Arm Description
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 )
Arm Title
BioHpp bar supported and retained overdenture
Arm Type
Other
Arm Description
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 )
Intervention Type
Procedure
Intervention Name(s)
surgical ( implants placement)
Other Intervention Name(s)
Final prosthesis was constructed on the 4 implants
Intervention Description
4 implants were placed interforamen of the mandibular arch by using the surgical guide
Primary Outcome Measure Information:
Title
bone height change around implants
Description
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.
Time Frame
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 Measure Information:
Title
patient satisfactions
Description
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.
Time Frame
6 months and 18 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
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
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1- sufficient inter arch distance. 2. good oral hygiene. 3. Enough bone volume in interforaminal region.
Exclusion Criteria:
TMJ disorders.
Radiotherapy or chemotherapy.
Diabetes mellitus
Uncooperative patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud H El Afandy, prof
Organizational Affiliation
faculty of dentistry ,Ain Shames University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Magda H Mohamed, lectu
Organizational Affiliation
faculty of dentistry ,Ain Shames University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prosthodontics Department Faculty of Dentistry
City
Cairo
State/Province
Ain Shames University
ZIP/Postal Code
11591
Country
Egypt
12. IPD Sharing Statement
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BioHPP Hybrid Prosthesis Versus BioHPP Bar Implant Supported and Retained Overdenture Rehabilitating Edentulous Mandible
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