Bone Loss in JawNCT07360015
Radiographic Evaluation of Bone Level Evaluation Around Implants in All on Four Hybrid OT Restorations With Different Number of Screws
A study testing OT Equator abutments with 3 screws. and OT Equator abutments with 4 screws. 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 OT Equator abutments for constructing implant supported fixed mandibular prosthesis with different number of screws (3 screws vs 4 screws) 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?
- OT Equator abutments with 3 screws. and OT Equator abutments with 4 screws.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Dec 2024to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 OT Equator abutments for constructing implant supported fixed mandibular prosthesis with different number of screws (3 screws vs 4 screws) regarding the marginal bone height alteration around the implants through radiographic evaluation.
Read the detailed description
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.
The first group will include seven patients who will be planned to receive screw retained implant supported mandibular prosthesis with OT Equator abutments (3 screws).
The second group will include seven patients who will be planned to receive screw retained implant supported mandibular prosthesis with OT Equator abutments (4 screws).
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, and the 3D surgical guide will be used to insert four implants in mandibular canines and mandibular first molar positions.
OT EQUATOR abutments will be screwed to the four implants. Denture conversion was done for temporization:
After three months of implant insertion, the final prosthesis will be constructed and then screwed to the OT Equator abutments.
For the first group one screw will be avoided and the final prosthesis will be screwed to the OT Equator abutments with 3 screws only.
For the second group and the final prosthesis will be screwed to the OT Equator abutments with 4 screws.
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. Bone loss measurements will be tabulated and statistically analyzed.
- Conditions
- Bone Loss in Jaw
- Being tested
- OT Equator abutments with 3 screws., OT Equator abutments with 4 screws.
- Keywords
- implant-supported prostheses, OT abutments, crestal bone loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OT Equator abutments with 3 screws.Other
screw retained implant supported mandibular prosthesis with OT Equator abutments (3 screws).
OT Equator abutments with 4 screws.Other
screw retained implant supported mandibular prosthesis with OT Equator abutments (4 screws).
| Study group | Role | What they receive |
|---|---|---|
| 3 screws | Experimental | screw retained implant supported mandibular prosthesis with OT Equator abutments (3 screws). Receives: Other: OT Equator abutments with 3 screws. |
| 4 screws | Experimental | screw retained implant supported mandibular prosthesis with OT Equator abutments (4 screws). Receives: Other: OT Equator abutments with 4 screws. |
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
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 posted22 Jan 2026
- Study start3 Dec 2024
- Primary completion10 Mar 2025
- Study completionFeb 2026 (estimated)
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, Fayoum University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360015
- Sponsor's protocol ID
- FD-ERU-Rec 25
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2026
- Last updated
- 22 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 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Evaluation of Bone Level Evaluation Around Implants in All on Four Hybrid OT Restorations With Different Number of Screws
- ClinicalTrials.gov ID
- NCT07360015
- Acronym / sponsor ID
- FD-ERU-Rec 25
- Conditions
- Bone Loss in Jaw
- Keywords
- implant-supported prostheses, OT abutments, crestal bone loss
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Egyptian Russian University, Fayoum University
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- Feb 2026 (estimated)
- First posted
- 22 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 OT Equator abutments for constructing implant supported fixed mandibular prosthesis with different number of screws (3 screws vs 4 screws) regarding the marginal bone height alteration around the implants through radiographic evaluation.
Detailed description
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.
The first group will include seven patients who will be planned to receive screw retained implant supported mandibular prosthesis with OT Equator abutments (3 screws).
The second group will include seven patients who will be planned to receive screw retained implant supported mandibular prosthesis with OT Equator abutments (4 screws).
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, and the 3D surgical guide will be used to insert four implants in mandibular canines and mandibular first molar positions.
OT EQUATOR abutments will be screwed to the four implants. Denture conversion was done for temporization:
After three months of implant insertion, the final prosthesis will be constructed and then screwed to the OT Equator abutments.
For the first group one screw will be avoided and the final prosthesis will be screwed to the OT Equator abutments with 3 screws only.
For the second group and the final prosthesis will be screwed to the OT Equator abutments with 4 screws.
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. 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 |
|---|---|---|
| 3 screws | Experimental | Other: OT Equator abutments with 3 screws.screw retained implant supported mandibular prosthesis with OT Equator abutments (3 screws). |
| 4 screws | Experimental | Other: OT Equator abutments with 4 screws.screw retained implant supported mandibular prosthesis with OT Equator abutments (4 screws). |
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 |
|---|---|---|
| OT Equator abutments with 3 screws.screw retained implant supported mandibular prosthesis with OT Equator abutments (3 screws). | Other | 3 screws |
| OT Equator abutments with 4 screws.screw retained implant supported mandibular prosthesis with OT Equator abutments (4 screws). | Other | 4 screws |
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Bone Loss in Jaw
RecruitingObservational study
Immediate Molar Implants With Customized Healing Abutments in Different Post-Extraction Socket Classes
Tooth Loss, Alveolar Bone Loss
Enrolling by invitation
Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy
Laser Therapy, Periodontal Diseases
Active, not recruiting
A Follow-Up Study of Straight and Tapered Dental Implants in the Front Upper Jaw
Tooth Loss in the Anterior Maxilla, Partial Edentulism of the Maxilla
Not yet recruiting
NobelZygoma TiUltra Implant System Study
Edentulous Maxilla, Maxillary Bone Loss
RecruitingObservational study
Mandibular Overdentures vs All-on-4 With PEEK
Bone Loss in Jaw
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 OT Equator abutments with 3 screws. and OT Equator abutments with 4 screws. 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: under way, not looking for participants, as of the sponsor's last update on 22 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?
This study is still under way. Results are not available in the source record yet.
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 22 Jan 2026.