Posterior Mandible With Deficient Ridge WidthNCT07353086
Evaluation of Horizontal Mandibular Ridge Augmentation Through Subperiosteal Tunneling by Using Bovine Sticky Bone (Radio-Histological Study)
A study testing Ridge augmentation with enriched bovine sticky bone through the subperiosteal tunneling technique in the posterior mandible in people with Posterior Mandible With Deficient Ridge Width, run by Tanta University at 1 site in Egypt.
Trial summary
This clinical trial evaluated horizontal ridge augmentation in the posterior mandible using subperiosteal tunneling with enriched bovine bone graft matrix (sticky bone). The minimally invasive procedure addressed horizontal bone deficiencies without flap elevation, while preserving periosteal integrity and reducing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posterior Mandible With Deficient Ridge Width
- What is being tested?
- Ridge augmentation with enriched bovine sticky bone through the subperiosteal tunneling technique in the posterior mandible
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Aug 2024to 20 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adequate vertical ridge height but less than 4 mm of bone width in the posterior mandible, which required bone grafting.
- Patients who were motivated, cooperative, and had good oral hygiene.
Who cannot join
- Any uncontrolled systemic disease or medications that might compromise. healing, osseointegration or complicate the surgical procedures such as uncontrolled diabetes.
- Presence of fenestrations or dehiscence of the residual wall.
- Smoking habit of 20 cigarettes or more per day.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentisty ,university of Tanta
Tanta, Gharbia Governorate, 31527
About this study
This clinical trial evaluated horizontal ridge augmentation in the posterior mandible using subperiosteal tunneling with enriched bovine bone graft matrix (sticky bone). The minimally invasive procedure addressed horizontal bone deficiencies without flap elevation, while preserving periosteal integrity and reducing patient morbidity. Ten patients underwent clinical assessment of wound healing, pain, and neurosensory changes over 4 weeks; radiological evaluation of CBCT-measured bone width at immediate postoperative and 6-month follow-up; and histological analysis of bone core biopsies obtained at implant placement to evaluate remodeling and graft integration.
Read the detailed description
The alveolar bone is a tooth-dependent tissue that extends from the basal bone of the maxilla and mandible to form and support the tooth sockets. Resorption of alveolar bone may be attributed to a variety of factors, such as tooth loss, trauma, periodontal disease, and pathologies. Tooth loss is often followed by a bone remodeling process leading to gradual horizontal and vertical bone ridge reduction.
The posterior mandible is the most challenging region for reconstruction and implant placement due to its critical neurovascular structures, thick cortical bone, and reduced vascular trabecular bone, requiring careful treatment planning for successful outcomes Multiple techniques such as osteoplasty, narrow implants, bone augmentation, ridge splitting, and distraction osteogenesis address deficient ridge width. However, conventional augmentation in the posterior mandible requires flap elevation and barrier membranes, increasing risks of complications such as pain, swelling, wound dehiscence, and membrane exposure.
To address these limitations, this study employed the subperiosteal tunneling technique for horizontal augmentation of posterior edentulous ridges. By creating a subperiosteal pouch without extensive flap elevation, this approach reduces tissue trauma, preserves periosteal integrity essential for bone regeneration, and eliminates the need for barrier membranes by harnessing the periosteum's regenerative potential.
Bovine sticky bone was utilized for its cohesive properties, enhanced stability, and regenerative potential. (31) This study evaluated the radiological and histological outcomes of horizontal mandibular ridge augmentation through subperiosteal tunneling using enriched bovine bone graft matrix (sticky bone). Conducted at the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University.
Ten adult patients with mandibular horizontal alveolar ridge atrophy were included in the study. Their ages ranged from 34 to 42 years (mean ± SD: 38 ± 2.6). The gender distribution was 40% male and 60% female participants, reflecting women's predominance in dental treatment-seeking behavior.
At the 6-month follow-up, subperiosteal tunneling with sticky bone achieved a 90% success rate (9/10 patients). One 41-year-old female patient experienced failure (10%) due to an intraoperative tear during crestal tunneling, resulting in soft tissue compromise, infection, dehiscence, and total graft loss. The remaining patients demonstrated successful bone formation, rapid soft tissue healing with minimal morbidity, no dehiscence or graft exposure, and excellent long-term outcomes, confirming this technique's reliability as a membrane-free ridge augmentation alternative.
Clinical assessment of postoperative healing, using the Landry et al. healing index (161), demonstrated predictable progression from predominantly good healing at one week (60%) to universal excellent healing by one month, maintained through six months, which indicates a transient inflammatory response and a favorable biocompatibility and healing profile for the procedure.
Pain levels, assessed by the Visual Analog Scale (VAS), declined substantially throughout the treatment period. The mean VAS score was 3.70 ± 1.42 at one week, which significantly decreased to 1.30 ± 0.82 at two weeks. From the third week onward no pain was reported, with mean VAS scores consistently at 0 ± 0. Neurosensory function remained preserved throughout the follow-up period in all patients.
Radiographic assessment at six months demonstrated significant horizontal ridge augmentation with a mean width gain of 3.30 ± 0.97 mm. The calculated resorption rate of 17.58 ± 4.76% remained within biologically acceptable parameters for horizontal ridge augmentation procedures.
Histological examination of bone core specimens obtained during implant placement revealed Hematoxylin and Eosin (H\&E)-stained sections showing graft remnants well-integrated with mature lamellar bone, without evidence of inflammation or necrosis. Woven bone exhibited plump osteoblasts indicative of active bone formation, sparse osteoclasts with minimal resorption, and multiple reversal lines confirming ongoing remodeling. Osteoconduction was evident with graft particles surrounded by osteogenic cells and newly formed bone. Immunohistochemical analysis demonstrated strong osteocalcin expression within the bone matrix and moderate cytoplasmic staining in osteocytes of newly formed bone, confirming active mineralization and robust bone remodeling activity.
- Being tested
- Ridge augmentation with enriched bovine sticky bone through the subperiosteal tunneling technique in the posterior mandible
- Keywords
- ridge augmentation ,subperiosteal tunneling , sticky bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ridge augmentation with enriched bovine sticky bone through the subperiosteal tunneling technique in the posterior mandibleProcedure or surgery
Under local anesthesia, a 5-mm vertical incision was made in the attached gingiva remote from the augmentation site. A primary subperiosteal tunnel was then created using a microsurgical periosteal elevator and further extended with VISTA tunneling elevators from the Mitex VISTA Tunneling Kit (No. 1-6) for less accessible areas. Multiple cortical perforations were subsequently performed using a Piezo surgery® UI1 tip (1.6 mm) to enhance vascularity. Bovine sticky bone was delivered via a modified insulin syringe for precise placement, condensed using a bone condenser, and excess material was removed from the incision site. The graft was molded upward against the cortical bone to eliminate dead spaces. CGF membranes were placed over the graft site to support healing, followed by closure with simple interrupted sutures
| Study group | Role | What they receive |
|---|---|---|
| Horizontal Mandibular Ridge Augmentation through Subperiosteal Tunneling by Using Bovine sticky bone | Experimental | Participants underwent ridge augmentation with enriched bovine sticky bone delivered through subperiosteal tunneling in the posterior mandible Receives: Procedure: Ridge augmentation with enriched bovine sticky bone through the subperiosteal tunneling technique in the posterior mandible |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal Bone Gain in mm
The horizontal bone gain was measured radiographically using CBCT imaging to evaluate the effectiveness of ridge augmentation with enriched bovine sticky bone through subperiosteal tunneling in the posterior mandible."
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start25 Aug 2024
- Primary completion27 May 2025
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Mandible With Deficient Ridge WidthStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment Participants in this study received horizontal mandibular ridge augmentation using an enriched bovine bone graft matrix (sticky bone) through the subperiosteal tunneling technique
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Yousif Mohamed Elsayed, Tanta University
- Investigators
- Mohamed M Shoushan, Professor of OMFS, Study director, Faculty of Dentistry ,Tanta university ,EgyptDalia H Zahran, Professor of oral Biology, Principal investigator, Faculty of Dentistry ,Tanta university ,EgyptMaram N Breshah, Lecturer of OMFS, Principal investigator, Faculty of Dentistry ,Tanta university ,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353086
- Sponsor's protocol ID
- OS-4-24-2180.
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to protect participant privacy and confidentiality. The small sample size in this surgical study increases re-identification risk
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Horizontal Mandibular Ridge Augmentation Through Subperiosteal Tunneling by Using Bovine Sticky Bone (Radio-Histological Study)
- ClinicalTrials.gov ID
- NCT07353086
- Acronym / sponsor ID
- OS-4-24-2180.
- Keywords
- ridge augmentation ,subperiosteal tunneling , sticky bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 20 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 clinical trial evaluated horizontal ridge augmentation in the posterior mandible using subperiosteal tunneling with enriched bovine bone graft matrix (sticky bone). The minimally invasive procedure addressed horizontal bone deficiencies without flap elevation, while preserving periosteal integrity and reducing patient morbidity. Ten patients underwent clinical assessment of wound healing, pain, and neurosensory changes over 4 weeks; radiological evaluation of CBCT-measured bone width at immediate postoperative and 6-month follow-up; and histological analysis of bone core biopsies obtained at implant placement to evaluate remodeling and graft integration.
Detailed description
The alveolar bone is a tooth-dependent tissue that extends from the basal bone of the maxilla and mandible to form and support the tooth sockets. Resorption of alveolar bone may be attributed to a variety of factors, such as tooth loss, trauma, periodontal disease, and pathologies. Tooth loss is often followed by a bone remodeling process leading to gradual horizontal and vertical bone ridge reduction.
The posterior mandible is the most challenging region for reconstruction and implant placement due to its critical neurovascular structures, thick cortical bone, and reduced vascular trabecular bone, requiring careful treatment planning for successful outcomes Multiple techniques such as osteoplasty, narrow implants, bone augmentation, ridge splitting, and distraction osteogenesis address deficient ridge width. However, conventional augmentation in the posterior mandible requires flap elevation and barrier membranes, increasing risks of complications such as pain, swelling, wound dehiscence, and membrane exposure.
To address these limitations, this study employed the subperiosteal tunneling technique for horizontal augmentation of posterior edentulous ridges. By creating a subperiosteal pouch without extensive flap elevation, this approach reduces tissue trauma, preserves periosteal integrity essential for bone regeneration, and eliminates the need for barrier membranes by harnessing the periosteum's regenerative potential.
Bovine sticky bone was utilized for its cohesive properties, enhanced stability, and regenerative potential. (31) This study evaluated the radiological and histological outcomes of horizontal mandibular ridge augmentation through subperiosteal tunneling using enriched bovine bone graft matrix (sticky bone). Conducted at the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University.
Ten adult patients with mandibular horizontal alveolar ridge atrophy were included in the study. Their ages ranged from 34 to 42 years (mean ± SD: 38 ± 2.6). The gender distribution was 40% male and 60% female participants, reflecting women's predominance in dental treatment-seeking behavior.
At the 6-month follow-up, subperiosteal tunneling with sticky bone achieved a 90% success rate (9/10 patients). One 41-year-old female patient experienced failure (10%) due to an intraoperative tear during crestal tunneling, resulting in soft tissue compromise, infection, dehiscence, and total graft loss. The remaining patients demonstrated successful bone formation, rapid soft tissue healing with minimal morbidity, no dehiscence or graft exposure, and excellent long-term outcomes, confirming this technique's reliability as a membrane-free ridge augmentation alternative.
Clinical assessment of postoperative healing, using the Landry et al. healing index (161), demonstrated predictable progression from predominantly good healing at one week (60%) to universal excellent healing by one month, maintained through six months, which indicates a transient inflammatory response and a favorable biocompatibility and healing profile for the procedure.
Pain levels, assessed by the Visual Analog Scale (VAS), declined substantially throughout the treatment period. The mean VAS score was 3.70 ± 1.42 at one week, which significantly decreased to 1.30 ± 0.82 at two weeks. From the third week onward no pain was reported, with mean VAS scores consistently at 0 ± 0. Neurosensory function remained preserved throughout the follow-up period in all patients.
Radiographic assessment at six months demonstrated significant horizontal ridge augmentation with a mean width gain of 3.30 ± 0.97 mm. The calculated resorption rate of 17.58 ± 4.76% remained within biologically acceptable parameters for horizontal ridge augmentation procedures.
Histological examination of bone core specimens obtained during implant placement revealed Hematoxylin and Eosin (H\&E)-stained sections showing graft remnants well-integrated with mature lamellar bone, without evidence of inflammation or necrosis. Woven bone exhibited plump osteoblasts indicative of active bone formation, sparse osteoclasts with minimal resorption, and multiple reversal lines confirming ongoing remodeling. Osteoconduction was evident with graft particles surrounded by osteogenic cells and newly formed bone. Immunohistochemical analysis demonstrated strong osteocalcin expression within the bone matrix and moderate cytoplasmic staining in osteocytes of newly formed bone, confirming active mineralization and robust bone remodeling activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment Participants in this study received horizontal mandibular ridge augmentation using an enriched bovine bone graft matrix (sticky bone) through the subperiosteal tunneling technique
| Arm | Type | Receives |
|---|---|---|
| Horizontal Mandibular Ridge Augmentation through Subperiosteal Tunneling by Using Bovine sticky bone | Experimental | Procedure: Ridge augmentation with enriched bovine sticky bone through the subperiosteal tunneling technique in the posterior mandibleParticipants underwent ridge augmentation with enriched bovine sticky bone delivered through subperiosteal tunneling in the posterior mandible |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adequate vertical ridge height but less than 4 mm of bone width in the posterior mandible, which required bone grafting.
- Patients who were motivated, cooperative, and had good oral hygiene.
Key exclusion criteria (3 listed)
- Any uncontrolled systemic disease or medications that might compromise. healing, osseointegration or complicate the surgical procedures such as uncontrolled diabetes.
- Presence of fenestrations or dehiscence of the residual wall.
- Smoking habit of 20 cigarettes or more per day.
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 |
|---|---|---|
| Ridge augmentation with enriched bovine sticky bone through the subperiosteal tunneling technique in the posterior mandibleUnder local anesthesia, a 5-mm vertical incision was made in the attached gingiva remote from the augmentation site. A primary subperiosteal tunnel was then created using a microsurgical periosteal elevator and further extended with VISTA tunneling elevators from the Mitex VISTA Tunneling Kit (No. 1-6) for less accessible areas. Multiple cortical perforations were subsequently performed using a Piezo surgery® UI1 tip (1.6 mm) to enhance vascularity. Bovine sticky bone was delivered via a modified insulin syringe for precise placement, condensed using a bone condenser, and excess material was removed from the incision site. The graft was molded upward against the cortical bone to eliminate dead spaces. CGF membranes were placed over the graft site to support healing, followed by closure with simple interrupted sutures | Procedure or surgery | Horizontal Mandibular Ridge Augmentation through Subperiosteal Tunneling by Using Bovine sticky bone |
Primary outcome
Horizontal Bone Gain in mm
Time frame: 6 months postoperatively
The horizontal bone gain was measured radiographically using CBCT imaging to evaluate the effectiveness of ridge augmentation with enriched bovine sticky bone through subperiosteal tunneling in the posterior mandible."
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 20 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to protect participant privacy and confidentiality. The small sample size in this surgical study increases re-identification risk
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.
Mohamed M Shoushan, Professor of OMFS study director
Faculty of Dentistry ,Tanta university ,Egypt
Dalia H Zahran, Professor of oral Biology principal investigator
Faculty of Dentistry ,Tanta university ,Egypt
Maram N Breshah, Lecturer of OMFS principal investigator
Faculty of Dentistry ,Tanta university ,Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ridge augmentation with enriched bovine sticky bone through the subperiosteal tunneling technique in the posterior mandible in people with Posterior Mandible With Deficient Ridge Width, run by Tanta 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 2 inclusion and 3 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 20 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?
Horizontal Bone Gain in mm (time frame: 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 Jan 2026.