Ridge AugmentationNCT07140887
Autogenous Bone Ring Versus Split Bone Block for Management of Posterior Atrophic Mandible
A study testing Bone Ring and Split Bone block in people with Ridge Augmentation, run by Alexandria University at 1 site in Egypt.
Trial summary
Teeth loss in the posterior mandible initiates residual ridge resorption especially in vertical direction, this causes difficulty in implant placement so ridge augmentation must be done either simultaneous with implant placement or in a staged approach Aim: To evaluate the effect of bone ring technique versus split… Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Ridge Augmentation
- What is being tested?
- Bone Ring and Split Bone block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Aug 2024to 5 Aug 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 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with missing posterior mandibular teeth.
- Vertical bone defect from 3 to 4 mm.
- Adequate zone of keratinized tissue.
Who cannot join
- Presence of infection or periapical lesions in adjacent teeth.
- Medically compromised patients with a condition that affects the procedure.
- Insufficient inter-arch distance.
- Bruxism or clenching.
- Alcoholism.
- Heavy Smokers.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
About this study
Official title: Autogenous Bone Ring Versus Split Bone Block With Simultaneous Implant Placement for Management of Posterior Atrophic Mandible (A Randomized Clinical Trial)
Teeth loss in the posterior mandible initiates residual ridge resorption especially in vertical direction, this causes difficulty in implant placement so ridge augmentation must be done either simultaneous with implant placement or in a staged approach Aim: To evaluate the effect of bone ring technique versus split bone block technique with simultaneous implant clinically on primary and secondary
- Conditions
- Ridge Augmentation
- Being tested
- Bone Ring, Split Bone block
- Keywords
- Bone ring, trephine, piezotome, ridge augmentation, Khoury technique, implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone RingOther
Patients in this group will be treated with the bone ring technique. An implant drill will be used next to prepare central osteotomies corresponding to the final implant diameter to be placed in the center of the disc converting it to a "bone ring".
Split Bone blockOther
Patients of this group will be treated with split bone block with simultaneous implant technique. The bone shell will be split into two bone shells each 1 ~ 2 mm in thickness using a disc.
| Study group | Role | What they receive |
|---|---|---|
| Bone ring technique | Experimental | Not described Receives: Other: Bone Ring |
| Split bone block technique | Active comparator | Not described Receives: Other: Split Bone block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in implant stability
Implant stability will be recorded immediately after placement (1ry stability) and after 6 months (2ry stability ) by using osstell device. The result is presented in form of ISQ value from 1to 100, the higher the ISQ the higher the stability of implant(
Measured: Immediate and 6 months
Change in pain scores
Pain will be assessed for 7 days postoperatively using 10-point visual analouge scale (VAS) (0-1=None, 2-4=mild, 5-7=moderate, 8-10=severe ).
Measured: up to 7 days
Change in marginal bone level
At buccal, lingual, mesial, and distal sites will be evaluated radiographically from the shoulder of the implant to the alveolar crest.
Measured: 6 and 9 months
Secondary outcomes (2)
Change in bone density
Will be measured at 6 points around the implant and a mean value will be calculated using CBCT
Measured: 6 months
Change in edema
Measured as follows:
No inflammation = none. Intra oral swelling confined to the surgical field = mild. Extra oral swelling in the surgical zone =moderate. Extra oral swelling spreading beyond the surgical zone =intense.
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start26 Aug 2024
- Primary completion5 Aug 2025
- Study completion5 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge AugmentationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140887
- Sponsor's protocol ID
- 0917-05/2024
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 26 Aug 2025
- 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 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autogenous Bone Ring Versus Split Bone Block With Simultaneous Implant Placement for Management of Posterior Atrophic Mandible (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07140887
- Acronym / sponsor ID
- 0917-05/2024
- Conditions
- Ridge Augmentation
- Keywords
- Bone ring, trephine, piezotome, ridge augmentation, Khoury technique, implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 5 Aug 2025 (actual)
- First posted
- 26 Aug 2025 (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.
Teeth loss in the posterior mandible initiates residual ridge resorption especially in vertical direction, this causes difficulty in implant placement so ridge augmentation must be done either simultaneous with implant placement or in a staged approach Aim: To evaluate the effect of bone ring technique versus split bone block technique with simultaneous implant clinically on primary and secondary
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone ring technique | Experimental | Other: Bone Ring |
| Split bone block technique | Active comparator | Other: Split Bone block |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with missing posterior mandibular teeth.
- Vertical bone defect from 3 to 4 mm.
- Adequate zone of keratinized tissue.
Key exclusion criteria (6 listed)
- Presence of infection or periapical lesions in adjacent teeth.
- Medically compromised patients with a condition that affects the procedure.
- Insufficient inter-arch distance.
- Bruxism or clenching.
- Alcoholism.
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 |
|---|---|---|
| Bone RingPatients in this group will be treated with the bone ring technique. An implant drill will be used next to prepare central osteotomies corresponding to the final implant diameter to be placed in the center of the disc converting it to a "bone ring". | Other | Bone ring technique |
| Split Bone blockPatients of this group will be treated with split bone block with simultaneous implant technique. The bone shell will be split into two bone shells each 1 ~ 2 mm in thickness using a disc. | Other | Split bone block technique |
Primary outcome
Change in implant stability
Time frame: Immediate and 6 months
Implant stability will be recorded immediately after placement (1ry stability) and after 6 months (2ry stability ) by using osstell device. The result is presented in form of ISQ value from 1to 100, the higher the ISQ the higher the stability of implant(
Change in pain scores
Time frame: up to 7 days
Pain will be assessed for 7 days postoperatively using 10-point visual analouge scale (VAS) (0-1=None, 2-4=mild, 5-7=moderate, 8-10=severe ).
Change in marginal bone level
Time frame: 6 and 9 months
At buccal, lingual, mesial, and distal sites will be evaluated radiographically from the shoulder of the implant to the alveolar crest.
2 secondary outcomes
Change in bone density
Time frame: 6 months
Change in edema
Time frame: up to 7 days
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 26 Aug 2025.
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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 Bone Ring and Split Bone block in people with Ridge Augmentation, run by Alexandria 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 3 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 26 Aug 2025. 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?
Change in implant stability (time frame: Immediate and 6 months). The study lists 3 primary outcomes in all. 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 26 Aug 2025.