Horizontal Alveolar Ridge DeficiencyNCT07883603
Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
A study testing 25% Autogenous + 75% Xenograft and 50% Autogenous + 50% Xenograft in people with Horizontal Alveolar Ridge Deficiency, run by salah mohamed mohamed ibrahim ibrahim at 1 site in Egypt.
Trial summary
Following a tooth extraction, the loss of alveolar bone is inevitable. As the site remodels, the alveolar ridge naturally shrinks in both height and width (Schropp et al., 2003). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Horizontal Alveolar Ridge Deficiency
- What is being tested?
- 25% Autogenous + 75% Xenograft and 50% Autogenous + 50% Xenograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 1 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age Range: Patients aged 20-60 years (Slagter et al., 2021).
- Dentition Status: Partial edentulism in the posterior mandible involving the loss of two or more teeth.
- Ridge Dimensions: Severely deficient alveolar ridge width (≤ 4 mm) paired with adequate residual vertical bone height (≥ 9 mm) (Thoma et al., 2017).
- Systemic Health: Free from systemic diseases that could impair healing (Donos et al., 2015).
- Inter-arch Space: Sufficient intermaxillary clearance (8-12 mm) to accommodate the definitive prosthetic components (Misch et al., 2005).
- Oral Hygiene: Satisfactory oral hygiene status (Sälzer et al., 2020).
- Compliance: Patient cooperative and willing to adhere to a 6-month post-operative follow-up regimen.
Who cannot join
- Tobacco Use: Current smokers (Chrcanovic et al., 2015).
- Local Pathology: Presence of active pathological lesions (such as abscesses, cysts, or acute infections) at the surgical site (Atef et al., 2020).
- Pregnancy: Pregnant patients.
- Metabolic Status: Patients with uncontrolled diabetes.
- Pharmacological Interferences: Patients taking medications that alter bone metabolism or soft tissue healing (e.g., systemic corticosteroids, bisphosphonates, or undergoing chemotherapy/radiotherapy).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Clinical and Radiographic Study on the Efficacy of a 25-75% Autogenous-Xenograft Mix Versus a 50-50% Autogenous-Xenograft Mix for Horizontal Alveolar Ridge Reconstruction.
Following a tooth extraction, the loss of alveolar bone is inevitable. As the site remodels, the alveolar ridge naturally shrinks in both height and width (Schropp et al., 2003). This loss of bone volume can make dental implant placement challenging, frequently requiring bone grafting procedures to rebuild the necessary foundation for the implant.Guided bone regeneration (GBR) stands as a leading strategy for repairing osseous defects. When employing particulate bone grafts, this approach typically depends on the application of barrier membranes to promote the regeneration of bone tissue (Retzepi \& Donos, 2010).Various regenerative approaches have been proposed to restore ridge width: among these, guided bone regeneration (GBR) using a combination of autogenous bone and xenogenic grafts has gained widespread acceptance due to its biological properties and ability to achieve stable dimensional augmentation (Urban et al., 2013).Historically, various methods have been implemented to enhance both the volume and structural integrity of newly formed bone. An ideal graft material must act as an effective osteoconductive scaffold, facilitating cellular ingrowth while preserving its dimensional stability. Although autogenous bone is still considered the gold standard for these procedures, it is prone to significant volumetric resorption as time progresses (Gulinelli et al., 2017).To counteract volume loss during the remodeling process, researchers have proposed combining autogenous bone with allogenic, xenogenic, or alloplastic substitutes (Chappuis et al., 2017). This composite grafting strategy is designed to enhance both the structural stability and overall quality of the augmented site, while simultaneously decreasing surgical morbidity by minimizing the volume of autogenous bone required for harvest (Mendoza-Azpur et al., 2019).
Even though composite grafts are routinely employed in clinical practice, the ideal proportion of autogenous bone to xenogenic material in guided bone regeneration (GBR) protocols has yet to be definitively established.
- Conditions
- Horizontal Alveolar Ridge Deficiency
- Being tested
- 25% Autogenous + 75% Xenograft, 50% Autogenous + 50% Xenograft
- Keywords
- Horizontal alveolar ridge reconstruction, Alveolar ridge augmentation, Autogenous bone graft, Xenograft, Autogenous-xenograft mixture, Horizontal ridge augmentation, Alveolar ridge deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25% Autogenous + 75% XenograftProcedure or surgery
25% autogenous bone + 75% xenograft for horizontal alveolar ridge reconstruction
50% Autogenous + 50% XenograftProcedure or surgery
50% autogenous bone + 50% xenograft for horizontal alveolar ridge reconstruction
| Study group | Role | What they receive |
|---|---|---|
| 25% Autogenous + 75% Xenograft | Experimental | 25% autogenous bone + 75% xenograft for horizontal alveolar ridge reconstruction Receives: Procedure: 25% Autogenous + 75% Xenograft |
| 50% Autogenous + 50% Xenograft | Experimental | 50% autogenous bone + 50% xenograft for horizontal alveolar ridge reconstruction Receives: Procedure: 50% Autogenous + 50% Xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Horizontal Bone Gain
The radiographic horizontal bone gain will be assessed by comparing the horizontal alveolar ridge width before guided bone regeneration and at 6 months postoperatively using standardized CBCT measurements at predetermined reference points.
Measured: Baseline to 6 months postoperatively
Secondary outcomes (10)
Clinical Horizontal Bone Gain
Clinical horizontal bone gain will be assessed by measuring the alveolar ridge width at standardized reference points using a periodontal caliper before surgery and at 6 months postoperatively
Measured: Baseline to 6 months postoperatively
Quality of Bone
The quality of the regenerated bone will be evaluated histologically from a core biopsy obtained from the augmented site at the time of implant placement. Histological assessment will characterize the quality and composition of the regenerated bone
Measured: 6 months postoperatively, at implant placement
Vertical Bone Gain
Vertical bone gain will be assessed radiographically by comparing standardized CBCT measurements obtained before guided bone regeneration and at 6 months postoperatively.
Measured: Baseline to 6 months postoperatively
Keratinized Tissue Width
The width of keratinized tissue will be measured clinically at standardized sites using a UNC-15 graduated periodontal probe at baseline and at 6 months postoperatively.
Measured: Baseline and 3 and 6 months after augmentation
Soft Tissue Thickness
Soft tissue thickness will be measured at standardized sites using a needle with a stopper before treatment and at 6 months postoperatively.
Measured: Baseline and 3 and 6 months after augmentation
Incidence of Postoperative Infection
The incidence of postoperative infection will be recorded based on the presence or absence of clinical signs of infection, including swelling, suppuration, pain, or other clinical findings requiring intervention or antibiotic treatment.
Measured: 1 week, 2 weeks, and 6 months after augmentation
Postoperative Edema
Postoperative facial edema will be assessed using a flexible measuring thread at standardized facial reference points and recorded as the change in facial measurements following surgery
Measured: 1 week and 2 weeks after augmentation
Procedural Time
The total procedural time will be measured from the beginning of the surgical procedure until completion of wound closure using a stopwatch.
Measured: During the surgical procedure
Postoperative Pain
Patient-reported postoperative pain will be assessed using a Visual Analog Scale (VAS) during the postoperative follow-up period.
Measured: Day 1 to Day 14 after augmentation
Implant Primary Stability
Implant primary stability will be assessed at the time of implant placement using resonance frequency analysis and recorded as the Implant Stability Quotient (ISQ).
Measured: 6 months postoperatively, at implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 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
- The control group in this study utilizes a 50:50 ratio of autogenous bone to xenograft, a well-established composite grafting protocol frequently employed in guided bone regeneration (Urban et al., 2011). This specific blend provides an optimal equilibrium between the biological vitality of the autograft and the dimensional stability of the xenograft. The intervention group employs a 25:75 autogenous-to-xenograft ratio, designed to maximize volume stability without sacrificing adequate osteogenic potential. By comparing these formulations, this study aims to ascertain whether a decreased concentration of autogenous bone still yields successful regenerative outcomes during horizontal ridge augmentation using the sausage technique.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- salah mohamed mohamed ibrahim ibrahim
- Sponsor type
- University, hospital or other
- Collaborators
- Geistlich Pharma AG
- Responsible party
- Sponsor-investigator, salah mohamed mohamed ibrahim ibrahim, Cairo University
- Investigators
- Hani elnahass, prof., Study director, Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo Universityomnia khaled tawfik, assistant prof., Study director, Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883603
- Sponsor's protocol ID
- PER 6-3-2 GBR
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 20 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical and Radiographic Study on the Efficacy of a 25-75% Autogenous-Xenograft Mix Versus a 50-50% Autogenous-Xenograft Mix for Horizontal Alveolar Ridge Reconstruction.
- ClinicalTrials.gov ID
- NCT07883603
- Acronym / sponsor ID
- PER 6-3-2 GBR
- Conditions
- Horizontal Alveolar Ridge Deficiency
- Keywords
- Horizontal alveolar ridge reconstruction, Alveolar ridge augmentation, Autogenous bone graft, Xenograft, Autogenous-xenograft mixture, Horizontal ridge augmentation, Alveolar ridge deficiency
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- salah mohamed mohamed ibrahim ibrahimUniversity, hospital or other
- Collaborators
- Geistlich Pharma AG
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 20 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.
Following a tooth extraction, the loss of alveolar bone is inevitable. As the site remodels, the alveolar ridge naturally shrinks in both height and width (Schropp et al., 2003). This loss of bone volume can make dental implant placement challenging, frequently requiring bone grafting procedures to rebuild the necessary foundation for the implant.Guided bone regeneration (GBR) stands as a leading strategy for repairing osseous defects. When employing particulate bone grafts, this approach typically depends on the application of barrier membranes to promote the regeneration of bone tissue (Retzepi \& Donos, 2010).Various regenerative approaches have been proposed to restore ridge width: among these, guided bone regeneration (GBR) using a combination of autogenous bone and xenogenic grafts has gained widespread acceptance due to its biological properties and ability to achieve stable dimensional augmentation (Urban et al., 2013).Historically, various methods have been implemented to enhance both the volume and structural integrity of newly formed bone. An ideal graft material must act as an effective osteoconductive scaffold, facilitating cellular ingrowth while preserving its dimensional stability. Although autogenous bone is still considered the gold standard for these procedures, it is prone to significant volumetric resorption as time progresses (Gulinelli et al., 2017).To counteract volume loss during the remodeling process, researchers have proposed combining autogenous bone with allogenic, xenogenic, or alloplastic substitutes (Chappuis et al., 2017). This composite grafting strategy is designed to enhance both the structural stability and overall quality of the augmented site, while simultaneously decreasing surgical morbidity by minimizing the volume of autogenous bone required for harvest (Mendoza-Azpur et al., 2019).
Even though composite grafts are routinely employed in clinical practice, the ideal proportion of autogenous bone to xenogenic material in guided bone regeneration (GBR) protocols has yet to be definitively established.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The control group in this study utilizes a 50:50 ratio of autogenous bone to xenograft, a well-established composite grafting protocol frequently employed in guided bone regeneration (Urban et al., 2011). This specific blend provides an optimal equilibrium between the biological vitality of the autograft and the dimensional stability of the xenograft. The intervention group employs a 25:75 autogenous-to-xenograft ratio, designed to maximize volume stability without sacrificing adequate osteogenic potential. By comparing these formulations, this study aims to ascertain whether a decreased concentration of autogenous bone still yields successful regenerative outcomes during horizontal ridge augmentation using the sausage technique.
| Arm | Type | Receives |
|---|---|---|
| 25% Autogenous + 75% Xenograft | Experimental | Procedure: 25% Autogenous + 75% Xenograft25% autogenous bone + 75% xenograft for horizontal alveolar ridge reconstruction |
| 50% Autogenous + 50% Xenograft | Experimental | Procedure: 50% Autogenous + 50% Xenograft50% autogenous bone + 50% xenograft for horizontal alveolar ridge reconstruction |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age Range: Patients aged 20-60 years (Slagter et al., 2021).
- Dentition Status: Partial edentulism in the posterior mandible involving the loss of two or more teeth.
- Ridge Dimensions: Severely deficient alveolar ridge width (≤ 4 mm) paired with adequate residual vertical bone height (≥ 9 mm) (Thoma et al., 2017).
- Systemic Health: Free from systemic diseases that could impair healing (Donos et al., 2015).
- Inter-arch Space: Sufficient intermaxillary clearance (8-12 mm) to accommodate the definitive prosthetic components (Misch et al., 2005).
Key exclusion criteria (5 listed)
- Tobacco Use: Current smokers (Chrcanovic et al., 2015).
- Local Pathology: Presence of active pathological lesions (such as abscesses, cysts, or acute infections) at the surgical site (Atef et al., 2020).
- Pregnancy: Pregnant patients.
- Metabolic Status: Patients with uncontrolled diabetes.
- Pharmacological Interferences: Patients taking medications that alter bone metabolism or soft tissue healing (e.g., systemic corticosteroids, bisphosphonates, or undergoing chemotherapy/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 |
|---|---|---|
| 25% Autogenous + 75% Xenograft25% autogenous bone + 75% xenograft for horizontal alveolar ridge reconstruction | Procedure or surgery | 25% Autogenous + 75% Xenograft |
| 50% Autogenous + 50% Xenograft50% autogenous bone + 50% xenograft for horizontal alveolar ridge reconstruction | Procedure or surgery | 50% Autogenous + 50% Xenograft |
Primary outcome
Radiographic Horizontal Bone Gain
Time frame: Baseline to 6 months postoperatively
The radiographic horizontal bone gain will be assessed by comparing the horizontal alveolar ridge width before guided bone regeneration and at 6 months postoperatively using standardized CBCT measurements at predetermined reference points.
10 secondary outcomes
Clinical Horizontal Bone Gain
Time frame: Baseline to 6 months postoperatively
Quality of Bone
Time frame: 6 months postoperatively, at implant placement
Vertical Bone Gain
Time frame: Baseline to 6 months postoperatively
Keratinized Tissue Width
Time frame: Baseline and 3 and 6 months after augmentation
Soft Tissue Thickness
Time frame: Baseline and 3 and 6 months after augmentation
Incidence of Postoperative 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
Postoperative Pain
Time frame: Day 1 to Day 14 after augmentation
Implant Primary Stability
Time frame: 6 months postoperatively, at implant placement
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 20 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.
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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.
Hani elnahass, prof. study director
Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University
omnia khaled tawfik, assistant prof. study director
Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo 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 25% Autogenous + 75% Xenograft and 50% Autogenous + 50% Xenograft in people with Horizontal Alveolar Ridge Deficiency, run by salah mohamed mohamed ibrahim ibrahim 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 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 20 Oct 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?
Contact Salah Ibrahim, B.Sc. (02 01097010949, salah.ibrahim@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: Baseline to 6 months postoperatively). 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 20 Oct 2026.