Bone Loss in JawNCT07333235
Bone Level Evaluation Around Implants in All on Four Hybrid Restorations With Different Connections (Radiographic Evaluation)
A study testing different types of abutments (multiunit abutments OR OT EQUATOR abutments) will be screwed to the four implants to support the prosthesis in people with Bone Loss in Jaw, run by Ain Shams University at 1 site in Egypt.
Trial summary
this research aims to compare between using multiunit abutments and OT Equator abutments for constructing implant supported fixed mandibular prosthesis regarding the marginal bone height alteration around the implants through radiographic evaluation Read more about this study
- Who is it for?
- Ages 40 to 65 years, men only
- Conditions the study is for
- Bone Loss in Jaw
- What is being tested?
- different types of abutments (multiunit abutments OR OT EQUATOR abutments) will be screwed to the four implants to support the prosthesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jan 2024to 30 May 2025
- 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 40 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- completely edentulous patients
- male patients
- free from any systemic diseases
- no history of recent administration of chemotherapy or radiotherapy
- no history of para-functional habits
Who cannot join
- female patients
- diabetic patients and patients with bone metabolism diseases
- history of recent administration of chemotherapy or radiotherapy
- history of para-functional habits
- Heavy smokers.
- Heavy consumption of Alcohol
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Oral and Dental Medicine - Egyptian Russian University
Cairo, 11829
About this study
this research aims to compare between using multiunit abutments and OT Equator abutments for constructing implant supported fixed mandibular prosthesis regarding the marginal bone height alteration around the implants through radiographic evaluation
Read the detailed description
Patient selection:
Fourteen completely edentulous male patients free from any systemic diseases that would affect bone metabolism, had no history of recent administration of chemotherapy or radiotherapy and no history of para-functional habits will be selected from out-patients clinic.
Grouping of patients:
The first group will include seven patients who will be planned to receive screw retained implant supported mandibular prosthesis with multiunit abutments.
The second group will include seven patients who will be planned to receive screw retained implant supported mandibular prosthesis with OT Equator abutments.
Pre-surgical protocol:
For each patient, upper and lower complete dentures will be constructed. Using dual CBCT scan protocol, stereolithographic surgical guide will be constructed according to virtual implant planning in the software.
Surgical protocol:
The 3D surgical guide will be used to insert four implants in mandibular canines and mandibular first molar positions.
For the first group, multiunit abutments will be screwed to the four implants. For the second group, OT EQUATOR abutments will be screwed to the four implants.
Denture conversion for temporization:
Trans-mucosal abutments will be used to convert the denture to a temporary fixed implant supported restoration and will be screwed on multiunit abutments of the first group and on OT EQUATOR abutments for the second group.
Delivery of final prosthesis:
After three months of implant insertion, the final prosthesis will be constructed and then screwed to the multiunit abutments for the first group and to the OT Equator abutments for the second group.
Radiographic Evaluation:
The DIGORA Optime intraoral sensor and a specially built acrylic template for each patient will be used to take intraoral radiographs with the standardized long cone paralleling technique to measure changes of crestal bone level around each implant. Periods of 0 (immediately after delivery of final prosthesis), 3, 6, and 9 months after delivery of final prosthesis for radiographic evaluation.
Statistical analysis:
Bone loss measurements will be tabulated and statistically analyzed.
- Conditions
- Bone Loss in Jaw
- Being tested
- different types of abutments (multiunit abutments OR OT EQUATOR abutments) will be screwed to the four implants to support the prosthesis
- Keywords
- implant-supported prostheses, OT abutment, multi-unit abutment, crestal bone loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different types of abutments (multiunit abutments OR OT EQUATOR abutments) will be screwed to the four implants to support the prosthesisOther
for one group, multiunit abutments will be screwed to the four implants to support the prosthesis.
for the second group, OT EQUATOR abutments will be screwed to the four implants to support the prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| multiunit abutments | Experimental | multiunit abutments will be used to support the implant-supported prostheses Receives: Other: different types of abutments (multiunit abutments OR OT EQUATOR abutments) will be screwed to the four implants to support the prosthesis |
| OT EQUATOR abutments | Experimental | OT EQUATOR abutments will be used to support the implant-supported prostheses Receives: Other: different types of abutments (multiunit abutments OR OT EQUATOR abutments) will be screwed to the four implants to support the prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
crestal bone loss around implants
The DIGORA Optime intraoral sensor and a specially built acrylic template for each patient will be used to take intraoral radiographs with the standardized long cone paralleling technique to measure changes of crestal bone level around each implant. Periods of 0 (immediately after delivery of final prosthesis), 3, 6, and 9 months after delivery of final prosthesis for radiographic evaluation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start14 Jan 2024
- Primary completion14 May 2024
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Loss in JawStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Egyptian Russian University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333235
- Sponsor's protocol ID
- FD-ERU-Rec 24
- Status last verified
- Jun 2025
- First submitted
- 1 Jan 2026
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Level Evaluation Around Implants in All on Four Hybrid Restorations With Different Connections (Radiographic Evaluation)
- ClinicalTrials.gov ID
- NCT07333235
- Acronym / sponsor ID
- FD-ERU-Rec 24
- Conditions
- Bone Loss in Jaw
- Keywords
- implant-supported prostheses, OT abutment, multi-unit abutment, crestal bone loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Egyptian Russian University
- Study start
- 14 Jan 2024 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 12 Jan 2026 (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.
this research aims to compare between using multiunit abutments and OT Equator abutments for constructing implant supported fixed mandibular prosthesis regarding the marginal bone height alteration around the implants through radiographic evaluation
Detailed description
Patient selection:
Fourteen completely edentulous male patients free from any systemic diseases that would affect bone metabolism, had no history of recent administration of chemotherapy or radiotherapy and no history of para-functional habits will be selected from out-patients clinic.
Grouping of patients:
The first group will include seven patients who will be planned to receive screw retained implant supported mandibular prosthesis with multiunit abutments.
The second group will include seven patients who will be planned to receive screw retained implant supported mandibular prosthesis with OT Equator abutments.
Pre-surgical protocol:
For each patient, upper and lower complete dentures will be constructed. Using dual CBCT scan protocol, stereolithographic surgical guide will be constructed according to virtual implant planning in the software.
Surgical protocol:
The 3D surgical guide will be used to insert four implants in mandibular canines and mandibular first molar positions.
For the first group, multiunit abutments will be screwed to the four implants. For the second group, OT EQUATOR abutments will be screwed to the four implants.
Denture conversion for temporization:
Trans-mucosal abutments will be used to convert the denture to a temporary fixed implant supported restoration and will be screwed on multiunit abutments of the first group and on OT EQUATOR abutments for the second group.
Delivery of final prosthesis:
After three months of implant insertion, the final prosthesis will be constructed and then screwed to the multiunit abutments for the first group and to the OT Equator abutments for the second group.
Radiographic Evaluation:
The DIGORA Optime intraoral sensor and a specially built acrylic template for each patient will be used to take intraoral radiographs with the standardized long cone paralleling technique to measure changes of crestal bone level around each implant. Periods of 0 (immediately after delivery of final prosthesis), 3, 6, and 9 months after delivery of final prosthesis for radiographic evaluation.
Statistical analysis:
Bone loss measurements will be tabulated and statistically analyzed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multiunit abutments | Experimental | Other: different types of abutments (multiunit abutments OR OT EQUATOR abutments) will be screwed to the four implants to support the prosthesismultiunit abutments will be used to support the implant-supported prostheses |
| OT EQUATOR abutments | Experimental | Other: different types of abutments (multiunit abutments OR OT EQUATOR abutments) will be screwed to the four implants to support the prosthesisOT EQUATOR abutments will be used to support the implant-supported prostheses |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- completely edentulous patients
- male patients
- free from any systemic diseases
- no history of recent administration of chemotherapy or radiotherapy
- no history of para-functional habits
Key exclusion criteria (6 listed)
- female patients
- diabetic patients and patients with bone metabolism diseases
- history of recent administration of chemotherapy or radiotherapy
- history of para-functional habits
- Heavy smokers.
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 |
|---|---|---|
| different types of abutments (multiunit abutments OR OT EQUATOR abutments) will be screwed to the four implants to support the prosthesisfor one group, multiunit abutments will be screwed to the four implants to support the prosthesis. for the second group, OT EQUATOR abutments will be screwed to the four implants to support the prosthesis. | Other | OT EQUATOR abutments, multiunit abutments |
Primary outcome
crestal bone loss around implants
Time frame: 12 months
The DIGORA Optime intraoral sensor and a specially built acrylic template for each patient will be used to take intraoral radiographs with the standardized long cone paralleling technique to measure changes of crestal bone level around each implant. Periods of 0 (immediately after delivery of final prosthesis), 3, 6, and 9 months after delivery of final prosthesis for radiographic evaluation.
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 12 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing different types of abutments (multiunit abutments OR OT EQUATOR abutments) will be screwed to the four implants to support the prosthesis in people with Bone Loss in Jaw, 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 5 inclusion and 6 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 12 Jan 2026. 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?
crestal bone loss around implants (time frame: 12 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 12 Jan 2026.