AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
What is being tested?
Ridge augmentation with enriched bovine sticky bone through the subperiosteal tunneling technique in the posterior mandible
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

Other trials in Egypt

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 groups in NCT07353086
Study groupRoleWhat they receive
Horizontal Mandibular Ridge Augmentation through Subperiosteal Tunneling by Using Bovine sticky boneExperimentalParticipants 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.

  1. 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.

  1. First posted20 Jan 2026
  2. Study start25 Aug 2024
  3. Primary completion27 May 2025
  4. Study completion20 Jul 2025

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in