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Horizontal Alveolar Ridge AugmentationNCT07885748

Four Different Guided Bone Regeneration Strategies for Horizontal Ridge Augmentation in the Maxillary Esthetic Zone With Simultaneous Implant Placement: a Randomized Clinical Trial

A study testing Titanium Mesh-Guided Bone Regeneration, Extended Sticky Bone Augmentation and Medpark Bone Graft Augmentation in people with Horizontal Alveolar Ridge Augmentation, run by Mansoura 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
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Trial summary

This randomized clinical trial aims to evaluate and compare the clinical and radiographic outcomes of four different bone regeneration strategies for horizontal alveolar ridge augmentation with simultaneous dental implant placement in the maxillary esthetic zone. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Horizontal Alveolar Ridge Augmentation
What is being tested?
Titanium Mesh-Guided Bone Regeneration, Extended Sticky Bone Augmentation and Medpark Bone Graft Augmentation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
1 Sep 2025to 1 Mar 2026
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 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients aged 18-45 years.
  • Good oral hygiene.
  • Presence of horizontal alveolar ridge deficiency in the anterior maxilla (Siebert Class I).
  • Absence of deep undercuts on the buccal aspect of the alveolar ridge.
  • Presence of at least 3 mm of keratinized gingiva.
  • Adequate inter-arch space for dental implant rehabilitation.
  • Ability to comply with scheduled follow-up visits.

Who cannot join

  • Patients with systemic conditions contraindicating surgery or dental implant placement.
  • Smokers.
  • Pregnant women.
  • Patients with parafunctional habits, such as bruxism.
  • Patients with local pathological conditions affecting bone healing.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Dentistry, Mansoura University

    Al Mansurah, 35516

Other trials in Egypt

About this study

This randomized clinical trial aims to evaluate and compare the clinical and radiographic outcomes of four different bone regeneration strategies for horizontal alveolar ridge augmentation with simultaneous dental implant placement in the maxillary esthetic zone.

A total of 40 patients with horizontal alveolar ridge deficiency in the anterior maxilla will be randomly allocated into four equal groups (10 patients per group). Group I will receive titanium mesh-guided bone regeneration (GBR) with xenogeneic bone graft, Group II will receive extended sticky bone (ESB), Group III will receive Medpark bone graft, and Group IV will receive Ethoss synthetic bone graft. Dental implants will be placed simultaneously with ridge augmentation in all groups.

Read more

Clinical outcomes will include implant stability measured using resonance frequency analysis (Implant Stability Quotient, ISQ) and soft tissue healing assessed using the Landry Healing Index. Radiographic outcomes will include changes in bone volume evaluated using cone-beam computed tomography (CBCT) before surgery, immediately after surgery, and at six months postoperatively.

The study aims to determine whether these four bone regeneration strategies differ in their ability to achieve bone augmentation, maintain bone volume, support implant stability, and promote favorable soft tissue healin

Read the detailed description

Horizontal alveolar ridge deficiency following tooth extraction is a common clinical challenge, particularly in the maxillary esthetic zone, where adequate bone volume is essential for optimal dental implant positioning and esthetic rehabilitation. Guided bone regeneration (GBR) techniques and different bone grafting materials have been developed to improve alveolar ridge dimensions and support successful implant placement. However, comparative clinical evidence regarding different augmentation strategies remains important for selecting appropriate regenerative approaches.

This prospective, randomized, four-arm clinical trial will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University, Egypt.

A total of 40 patients requiring dental implant rehabilitation in the anterior maxilla with horizontal alveolar ridge deficiency (Siebert Class I) will be recruited. Participants will be randomly allocated to four equal groups using a computer-generated block randomization sequence with a fixed block size of four. The allocation sequence will be prepared by an independent investigator who will not participate in patient enrollment, surgical treatment, or outcome assessment.

All participants will undergo preoperative clinical and radiographic assessment, including cone-beam computed tomography (CBCT) for surgical planning. Under local anesthesia, a full-thickness mucoperiosteal flap will be elevated, and dental implants will be inserted into their planned prosthetic positions. Horizontal ridge augmentation will then be performed according to group allocation.

Group I: Titanium Mesh-Guided Bone Regeneration

Ten patients will receive horizontal ridge augmentation using a xenogeneic bone graft supported by titanium mesh. The mesh will be adapted to the defect and stabilized using fixation screws to maintain space and support bone regeneration.

Group II: Extended Sticky Bone

Ten patients will receive extended sticky bone (ESB), prepared by combining platelet-rich fibrin components, thermally processed plasma-derived albumin gel, and xenogeneic bone graft particles. The resulting cohesive graft material will be adapted around the dental implant to reconstruct the horizontal ridge defect.

Group III: Medpark Bone Graft

Ten patients will receive horizontal ridge augmentation using Medpark, a xenogeneic bone substitute with a moldable consistency following hydration. The graft will be adapted to the defect to augment alveolar ridge width.

Group IV: Ethoss Synthetic Bone Graft

Ten patients will receive horizontal ridge augmentation using Ethoss, a synthetic bone substitute composed of beta-tricalcium phosphate and calcium sulfate. The graft will be hydrated with sterile saline, applied to the defect, and allowed to harden.

In all groups, the graft material will be contoured to the desired ridge dimensions, followed by tension-free primary soft tissue closure.

Postoperative follow-up will include clinical assessment of wound healing and implant stability. A second-stage surgical procedure will be performed after six months to expose the implants and place healing abutments, followed by prosthetic rehabilitation using zirconia crowns.

Implant stability will be evaluated immediately after implant placement and at six months using resonance frequency analysis (RFA), expressed as Implant Stability Quotient (ISQ) values.

Soft tissue healing will be assessed using the Landry Healing Index at two weeks, four weeks, three months, and six months postoperatively.

Radiographic assessment will be performed using CBCT at baseline (T0), immediately after surgery within one week (T1), and six months postoperatively (T6). Three-dimensional volumetric analysis will be used to determine bone volume changes, including initial bone gain, six-month bone gain, and changes in augmented bone volume during healing.

Statistical analysis will be conducted using SPSS version 26. Data distribution will be assessed using the Shapiro-Wilk test. Parametric or nonparametric statistical tests will be selected according to data distribution, and categorical variables will be analyzed using appropriate categorical tests. Statistical significance will be set at p ≤ 0.05.

The study will compare the clinical and radiographic performance of four bone regeneration strategies to provide evidence supporting the selection of augmentation techniques during simultaneous dental implant placement in the maxillary esthetic zone.

Being tested
Titanium Mesh-Guided Bone Regeneration, Extended Sticky Bone Augmentation, Medpark Bone Graft Augmentation, Ethoss Synthetic Bone Graft Augmentation
Keywords
Horizontal Alveolar Ridge Augmentation, Guided Bone Regeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Titanium Mesh-Guided Bone RegenerationProcedure or surgery

    Horizontal ridge augmentation will be performed using a xenogeneic bone graft (GARANTIE, GmbH, Germany) supported by titanium mesh. The mesh will be stabilized buccally and palatally using 1.4 mm fixation screws following simultaneous implant placement.

  • Extended Sticky Bone AugmentationProcedure or surgery

    Extended sticky bone will be prepared using platelet-rich fibrin, thermally processed plasma-derived albumin, and xenogeneic bone graft (GARANTIE, GmbH, Germany). The graft will be applied around the simultaneously placed dental implant to reconstruct the horizontal ridge deficiency.

  • Medpark Bone Graft AugmentationProcedure or surgery

    Horizontal ridge augmentation will be performed using Medpark xenogeneic bone graft (Medpark Regeneration, Seoul, Republic of Korea). The graft will be hydrated and adapted to the defect site following simultaneous dental implant placement.

  • Ethoss Synthetic Bone Graft AugmentationProcedure or surgery

    Horizontal ridge augmentation will be performed using Ethoss synthetic bone graft composed of beta-tricalcium phosphate and calcium sulfate. The material will be hydrated with sterile saline, adapted to the defect around the simultaneously placed dental implant, and allowed to harden using sterile gauze for 3-5 minutes.

Study groups in NCT07885748
Study groupRoleWhat they receive
Titanium Mesh-Guided Bone RegenerationExperimentalTen patients will undergo simultaneous dental implant placement and horizontal ridge augmentation using a xenogeneic bone graft supported by titanium mesh. The titanium mesh will be adapted to the bone defect and secured using 1.4 mm fixation screws to maintain space and support bone regeneration.
Receives: Procedure: Titanium Mesh-Guided Bone Regeneration
Extended Sticky Bone (ESB)ExperimentalTen patients will undergo simultaneous dental implant placement and horizontal ridge augmentation using extended sticky bone (ESB), prepared by combining platelet-rich fibrin components, thermally denatured plasma-derived albumin, and xenogeneic bone graft particles. The resulting cohesive graft will be adapted around the implant to reconstruct the horizontal ridge defect.
Receives: Procedure: Extended Sticky Bone Augmentation
Medpark Bone GraftExperimentalTen patients will undergo simultaneous dental implant placement and horizontal ridge augmentation using Medpark xenogeneic bone graft. The graft material will be hydrated and adapted to the horizontal bone defect to increase alveolar ridge width.
Receives: Procedure: Medpark Bone Graft Augmentation
Ethoss Synthetic Bone GraftExperimentalten patients will undergo simultaneous dental implant placement and horizontal ridge augmentation using Ethoss, a synthetic bone substitute composed of beta-tricalcium phosphate and calcium sulfate. The graft will be hydrated with sterile saline, applied to the horizontal ridge defect, and allowed to harden.
Receives: Procedure: Ethoss Synthetic Bone Graft Augmentation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Alveolar Bone Volume From Baseline to 6 Months

    Three-dimensional alveolar bone volume will be assessed using cone-beam computed tomography (CBCT) before surgery (T0) and at 6 months postoperatively (T6). Bone volume gain will be calculated as the difference between bone volume at 6 months and baseline (T6 - T0). The outcome will be compared among the four treatment groups.

    Measured: Baseline (preoperative) and 6 months postoperatively

Secondary outcomes (4)
  1. Change in Implant Stability Quotient (ISQ) From Implant Placement to 6 Months

    Implant stability will be assessed using resonance frequency analysis (RFA) with an Osstell device. Implant Stability Quotient (ISQ) values will be recorded immediately after implant placement and at 6 months postoperatively. Change in stability will be calculated as the 6-month ISQ value minus the initial ISQ value. Higher ISQ values indicate greater implant stability.

    Measured: immediately after implant placement and at 6 months postoperatively.

  2. Soft Tissue Healing Assessed by the Landry Healing Index

    Postoperative soft tissue healing will be evaluated using the Landry Healing Index, based on tissue color, bleeding on palpation, presence of granulation tissue, incision margin condition, and degree of epithelialization. Healing will be assessed at 2 weeks, 4 weeks, 3 months, and 6 months following surgery.

    Measured: 2 weeks, 4 weeks, 3 months, and 6 months postoperatively.

  3. Initial Alveolar Bone Volume Gain

    Three-dimensional bone volume will be measured using cone-beam computed tomography (CBCT) preoperatively (T0) and within one week after surgery (T1). Initial bone volume gain will be calculated as T1 minus T0.

    Measured: Preoperatively and within 1 week postoperatively

  4. Change in Augmented Bone Volume During Healing

    Bone volume will be assessed using CBCT immediately postoperatively (T1) and at 6 months (T6). The change will be calculated as T6 minus T1, with negative values indicating bone volume loss.

    Measured: Within 1 week postoperatively and at 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2026
  2. Study start1 Sep 2025
  3. Primary completion1 Mar 2026
  4. Study completion1 Mar 2026

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
Randomised
Intervention model
Parallel groups
Model description
This study is a prospective, randomized, four-arm, parallel-group clinical trial involving 40 patients with horizontal alveolar ridge deficiency in the maxillary esthetic zone. Participants will be randomly assigned to four equal groups (10 patients per group) using a computer-generated block randomization sequence with a fixed block size of four. Group I will receive titanium mesh-guided bone regeneration with xenogeneic bone graft, Group II will receive extended sticky bone (ESB), Group III will receive Medpark bone graft, and Group IV will receive Ethoss synthetic bone graft. All participants will undergo simultaneous dental implant placement, followed by clinical and radiographic evaluation over six months.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07885748
Sponsor's protocol ID
R.26.09.138
Status last verified
Oct 2026
First submitted
13 Oct 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Titanium Mesh-Guided Bone Regeneration, Extended Sticky Bone Augmentation and Medpark Bone Graft Augmentation in people with Horizontal Alveolar Ridge Augmentation, run by Mansoura 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 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: finished, as of the sponsor's last update on 21 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?

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 Alveolar Bone Volume From Baseline to 6 Months (time frame: Baseline (preoperative) and 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 21 Oct 2026.

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