Marginal Bone LossBioHPPNCT05468983
BioHPP Hybrid Prosthesis Versus BioHPP Bar Implant Supported and Retained Overdenture Rehabilitating Edentulous Mandible
A study testing surgical ( implants placement) in people with Marginal Bone Loss and Patient Satisfaction, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Marginal Bone Loss, Patient Satisfaction
- What is being tested?
- surgical ( implants placement)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 21 May 2018to 20 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1- sufficient inter arch distance. 2. good oral hygiene. 3. Enough bone volume in interforaminal region.
Who cannot join
- TMJ disorders.
- Radiotherapy or chemotherapy.
- Diabetes mellitus
- Uncooperative patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Prosthodontics Department Faculty of Dentistry
Cairo, Ain Shames University, 11591
About this study
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.
Read the 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
- Being tested
- surgical ( implants placement)
- Keywords
- BioHpp, hybrid prosthesis, overdenture, bone loss
- Medical subject headings
- Patient Satisfaction, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical ( implants placement)Procedure or surgery
Also called Final prosthesis was constructed on the 4 implants
4 implants were placed interforamen of the mandibular arch by using the surgical guide
| Study group | Role | What they receive |
|---|---|---|
| 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 ) Receives: 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 ) Receives: Procedure: surgical ( implants placement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 6 months and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start21 May 2018
- Primary completion20 Dec 2021
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marginal Bone LossStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud H El Afandy, prof, Study director, faculty of dentistry ,Ain Shames UniversityMagda H Mohamed, lectu, Principal investigator, faculty of dentistry ,Ain Shames University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468983
- Sponsor's protocol ID
- 686
- Acronym
- BioHPP
- Status last verified
- Jul 2022
- First submitted
- 30 Mar 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BioHPP Hybrid Prosthesis Versus BioHPP Bar Implant Supported and Retained Overdenture Rehabilitating Edentulous Mandible
- ClinicalTrials.gov ID
- NCT05468983
- Acronym / sponsor ID
- BioHPP / 686
- Conditions
- Marginal Bone Loss, Patient Satisfaction
- Keywords
- BioHpp, hybrid prosthesis, overdenture, bone loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| BioHpp hybrid prosthesis( fixed ) | Other | Procedure: surgical ( implants placement)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 ) |
| BioHpp bar supported and retained overdenture | Other | Procedure: surgical ( implants placement)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 ) |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1- sufficient inter arch distance. 2. good oral hygiene. 3. Enough bone volume in interforaminal region.
Key exclusion criteria (4 listed)
- TMJ disorders.
- Radiotherapy or chemotherapy.
- Diabetes mellitus
- Uncooperative patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical ( implants placement)Also: Final prosthesis was constructed on the 4 implants4 implants were placed interforamen of the mandibular arch by using the surgical guide | Procedure or surgery | BioHpp bar supported and retained overdenture, BioHpp hybrid prosthesis( fixed ) |
Primary outcome
bone height change around implants
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
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.
1 secondary outcome
patient satisfactions
Time frame: 6 months and 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud H El Afandy, prof study director
faculty of dentistry ,Ain Shames University
Magda H Mohamed, lectu principal investigator
faculty of dentistry ,Ain Shames University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical ( implants placement) in people with Marginal Bone Loss and Patient Satisfaction, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone height change around implants (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.