Horizontal Alveolar Ridge DeficiencyNCT07865624
Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
A study testing 50:50 Autogenous Bone-Xenograft and 75:25 Autogenous Bone-Xenograft in people with Horizontal Alveolar Ridge Deficiency, run by Eslam hisham mohamed.
Trial summary
This pilot randomized controlled clinical study will evaluate horizontal bone gain in patients with deficient alveolar ridges requiring horizontal ridge augmentation. The study will compare two different ratios of autogenous bone and xenograft used for bone augmentation. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Horizontal Alveolar Ridge Deficiency
- What is being tested?
- 50:50 Autogenous Bone-Xenograft and 75:25 Autogenous Bone-Xenograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Sep 2027
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 20 to 70 years.
- Patients with multiple missing mandibular posterior teeth (2 or more).
- Patients with compromised bone width in the posterior mandible (≤4 mm) and adequate bone height (not less than 9 mm).
- Patients with healthy systemic condition.
- Adequate inter-arch space for placement of the implant prosthetic part (8-12 mm).
- Good oral hygiene.
- Cooperative patients who are willing to commit to 6 months of follow-up.
Who cannot join
- Smokers.
- Pathological lesions (abscess, cyst, or acute infection) at the defect site.
- Pregnant females.
- Uncontrolled diabetic patients.
- Patients taking medications or receiving treatments that may interfere with healing, including corticosteroids, bisphosphonates, chemotherapy, or radiotherapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Bone Ratios on Horizontal Alveolar Ridge Augmentation Comparing 50-50% Versus 75-25% Autogenous Bone-Xenograft : A Pilot Randomized Controlled Clinical and Radiographic Study
This pilot randomized controlled clinical study will evaluate horizontal bone gain in patients with deficient alveolar ridges requiring horizontal ridge augmentation. The study will compare two different ratios of autogenous bone and xenograft used for bone augmentation. Participants will be randomly assigned to receive either a 50:50 mixture of autogenous bone and xenograft or a 75:25 mixture of autogenous bone and xenograft. Bone augmentation will be performed using the sausage technique with a collagen membrane. Changes in horizontal ridge dimensions will be evaluated radiographically using cone-beam computed tomography (CBCT) before treatment and during follow-up. The primary outcome will be horizontal bone gain at 6 months after augmentation.
- Conditions
- Horizontal Alveolar Ridge Deficiency
- Being tested
- 50:50 Autogenous Bone-Xenograft, 75:25 Autogenous Bone-Xenograft
- Keywords
- Horizontal Ridge Augmentation, Autogenous Bone, Xenograft, Guided Bone Regeneration, Horizontal Bone Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50:50 Autogenous Bone-XenograftProcedure or surgery
Horizontal alveolar ridge augmentation using a 50:50 mixture of autogenous bone and xenograft with a collagen membrane using the sausage technique
75:25 Autogenous Bone-XenograftProcedure or surgery
Horizontal alveolar ridge augmentation using a 75:25 mixture of autogenous bone and xenograft with a collagen membrane using the sausage technique.
| Study group | Role | What they receive |
|---|---|---|
| 50:50 Autogenous Bone-Xenograft | Experimental | Participants will receive horizontal alveolar ridge augmentation using a 50:50 mixture of autogenous bone and xenograft, covered with a collagen membrane using the sausage technique. Receives: Procedure: 50:50 Autogenous Bone-Xenograft |
| 75:25 Autogenous Bone-Xenograft | Experimental | Participants will receive horizontal alveolar ridge augmentation using a 75:25 mixture of autogenous bone and xenograft, covered with a collagen membrane using the sausage technique. Receives: Procedure: 75:25 Autogenous Bone-Xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Horizontal bone gain
Horizontal bone gain will be calculated as the difference in ridge width between the baseline and 6-month measurements
Measured: 6 months
Secondary outcomes (10)
Clinical Horizontal Bone Gain
The horizontal width of the augmented ridge will be clinically assessed at the time of surgical re-entry at 6 months using a calibrated bone caliper
Measured: 6 months after augmentation
Vertical Bone Gain
Vertical bone gain will be measured on CBCT as the difference in vertical ridge dimension between the preoperative and postoperative measurements
Measured: Baseline to 6 months after augmentation
Histomorphometric Bone Quality
Bone biopsies will be harvested at 6 months and analyzed histomorphometrically. The area percentage of newly formed bone will be calculated.
Measured: 6 months after augmentation
Soft Tissue Thickness
Soft tissue thickness will be measured using an endodontic spreader with a rubber stopper positioned on the soft tissue.
Measured: Baseline and 3 and 6 months after augmentation
Keratinized Tissue Width
Keratinized tissue width will be measured from the mid-buccal gingival margin to the mucogingival junction using a graduated periodontal probe.
Measured: Baseline and 3 and 6 months after augmentation
Incidence of Infection
Postoperative infection will be assessed based on the presence of localized suppuration or swelling.
Measured: 1 week, 2 weeks, and 6 months after augmentation
Postoperative Edema
Postoperative facial edema will be assessed objectively by measuring the distance between predetermined facial anatomical landmarks using a flexible measuring thread.
Measured: 1 week and 2 weeks after augmentation
Procedural Time
Procedural time will be measured using a stopwatch from the beginning to the completion of the surgical procedure.
Measured: During the surgical procedure
Patient Pain
Postoperative pain will be assessed using a visual analog scale (VAS) ranging from 0 to 10. Participants will record pain scores during the first 14 days after surgery.
Measured: Day 1 to Day 14 after augmentation
Implant Primary Stability
Implant primary stability will be assessed immediately after implant placement using resonance frequency analysis (RFA). The Implant Stability Quotient (ISQ) value will be recorded using an Osstell device with a SmartPeg.
Measured: Immediately after implant placement at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Horizontal Alveolar Ridge DeficiencyStudies 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
- Model description
- Participants will be randomly allocated in a 1:1 ratio to two parallel treatment arms comparing different ratios of autogenous bone and xenograft for horizontal alveolar ridge augmentation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eslam hisham mohamed
- Sponsor type
- University, hospital or other
- Collaborators
- Geistlich Pharma AG
- Responsible party
- Sponsor-investigator, Eslam hisham mohamed, Cairo University
- Investigators
- Eslam Hisham Mohamed, B.Sc., Principal investigator, Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865624
- Sponsor's protocol ID
- PER 6-3-1 GBR
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because no specific plan for IPD sharing has been established, and participant-level data will be retained by the research team for study and academic purposes.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bone Ratios on Horizontal Alveolar Ridge Augmentation Comparing 50-50% Versus 75-25% Autogenous Bone-Xenograft : A Pilot Randomized Controlled Clinical and Radiographic Study
- ClinicalTrials.gov ID
- NCT07865624
- Acronym / sponsor ID
- PER 6-3-1 GBR
- Conditions
- Horizontal Alveolar Ridge Deficiency
- Keywords
- Horizontal Ridge Augmentation, Autogenous Bone, Xenograft, Guided Bone Regeneration, Horizontal Bone Gain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Eslam hisham mohamedUniversity, hospital or other
- Collaborators
- Geistlich Pharma AG
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 8 Oct 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 pilot randomized controlled clinical study will evaluate horizontal bone gain in patients with deficient alveolar ridges requiring horizontal ridge augmentation. The study will compare two different ratios of autogenous bone and xenograft used for bone augmentation. Participants will be randomly assigned to receive either a 50:50 mixture of autogenous bone and xenograft or a 75:25 mixture of autogenous bone and xenograft. Bone augmentation will be performed using the sausage technique with a collagen membrane. Changes in horizontal ridge dimensions will be evaluated radiographically using cone-beam computed tomography (CBCT) before treatment and during follow-up. The primary outcome will be horizontal bone gain at 6 months after augmentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated in a 1:1 ratio to two parallel treatment arms comparing different ratios of autogenous bone and xenograft for horizontal alveolar ridge augmentation.
| Arm | Type | Receives |
|---|---|---|
| 50:50 Autogenous Bone-Xenograft | Experimental | Procedure: 50:50 Autogenous Bone-XenograftParticipants will receive horizontal alveolar ridge augmentation using a 50:50 mixture of autogenous bone and xenograft, covered with a collagen membrane using the sausage technique. |
| 75:25 Autogenous Bone-Xenograft | Experimental | Procedure: 75:25 Autogenous Bone-XenograftParticipants will receive horizontal alveolar ridge augmentation using a 75:25 mixture of autogenous bone and xenograft, covered with a collagen membrane using the sausage technique. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age from 20 to 70 years.
- Patients with multiple missing mandibular posterior teeth (2 or more).
- Patients with compromised bone width in the posterior mandible (≤4 mm) and adequate bone height (not less than 9 mm).
- Patients with healthy systemic condition.
- Adequate inter-arch space for placement of the implant prosthetic part (8-12 mm).
Key exclusion criteria (5 listed)
- Smokers.
- Pathological lesions (abscess, cyst, or acute infection) at the defect site.
- Pregnant females.
- Uncontrolled diabetic patients.
- Patients taking medications or receiving treatments that may interfere with healing, including corticosteroids, bisphosphonates, chemotherapy, or radiotherapy.
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 |
|---|---|---|
| 50:50 Autogenous Bone-XenograftHorizontal alveolar ridge augmentation using a 50:50 mixture of autogenous bone and xenograft with a collagen membrane using the sausage technique | Procedure or surgery | 50:50 Autogenous Bone-Xenograft |
| 75:25 Autogenous Bone-XenograftHorizontal alveolar ridge augmentation using a 75:25 mixture of autogenous bone and xenograft with a collagen membrane using the sausage technique. | Procedure or surgery | 75:25 Autogenous Bone-Xenograft |
Primary outcome
Radiographic Horizontal bone gain
Time frame: 6 months
Horizontal bone gain will be calculated as the difference in ridge width between the baseline and 6-month measurements
10 secondary outcomes
Clinical Horizontal Bone Gain
Time frame: 6 months after augmentation
Vertical Bone Gain
Time frame: Baseline to 6 months after augmentation
Histomorphometric Bone Quality
Time frame: 6 months after augmentation
Soft Tissue Thickness
Time frame: Baseline and 3 and 6 months after augmentation
Keratinized Tissue Width
Time frame: Baseline and 3 and 6 months after augmentation
Incidence of Infection
Time frame: 1 week, 2 weeks, and 6 months after augmentation
Postoperative Edema
Time frame: 1 week and 2 weeks after augmentation
Procedural Time
Time frame: During the surgical procedure
Patient Pain
Time frame: Day 1 to Day 14 after augmentation
Implant Primary Stability
Time frame: Immediately after implant placement at 6 months
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 14 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers because no specific plan for IPD sharing has been established, and participant-level data will be retained by the research team for study and academic purposes.
Related trials for Horizontal Alveolar Ridge Deficiency
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Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
Horizontal Alveolar Ridge Deficiency
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Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Shell Technique for Implant Site Development
Ridge Augmentation, Ridge Deficiency
Recruiting
Histological and Histomorphometric Assessment With Inflammatory Profile Analysis of Bone Tissue After Horizontal Ridge Augmentation Using Customized Porous Zirconia Shell
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Recruiting
Implant Phenotype Modification Via GBR and ADM
Horizontal Ridge Deficiency
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.
Eslam Hisham Mohamed, B.Sc. principal investigator
Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing 50:50 Autogenous Bone-Xenograft and 75:25 Autogenous Bone-Xenograft in people with Horizontal Alveolar Ridge Deficiency, run by Eslam hisham mohamed.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Eslam Hisham Mohamed, B.Sc. (+201117182392, eslam.younes@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Horizontal bone gain (time frame: 6 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 14 Oct 2026.