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

NCT07885748 | Completed

• 1 other identifier: R.26.09.138
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Conditions

Horizontal Alveolar Ridge Augmentation

Keywords

Horizontal Alveolar Ridge Augmentation; Guided Bone Regeneration

Outcome Measures

Primary Outcomes (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.

  Baseline (preoperative) and 6 months postoperatively

Secondary Outcomes (4)

• Change in Implant Stability Quotient (ISQ) From Implant Placement to 6 Months

  immediately after implant placement and at 6 months postoperatively.

• Soft Tissue Healing Assessed by the Landry Healing Index

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

• Initial Alveolar Bone Volume Gain

  Preoperatively and within 1 week postoperatively

• Change in Augmented Bone Volume During Healing

  Within 1 week postoperatively and at 6 months.

Study Arms (4)

Titanium Mesh-Guided Bone Regeneration

EXPERIMENTAL

Ten 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.

Procedure: Titanium Mesh-Guided Bone Regeneration

Extended Sticky Bone (ESB)

EXPERIMENTAL

Ten 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.

Procedure: Extended Sticky Bone Augmentation

Medpark Bone Graft

EXPERIMENTAL

Ten 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.

Procedure: Medpark Bone Graft Augmentation

Ethoss Synthetic Bone Graft

EXPERIMENTAL

ten 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.

Procedure: Ethoss Synthetic Bone Graft Augmentation

Interventions

Titanium Mesh-Guided Bone Regeneration PROCEDURE

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.

Titanium Mesh-Guided Bone Regeneration

Medpark Bone Graft Augmentation PROCEDURE

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.

Medpark Bone Graft

Extended Sticky Bone Augmentation PROCEDURE

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.

Extended Sticky Bone (ESB)

Ethoss Synthetic Bone Graft Augmentation PROCEDURE

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.

Ethoss Synthetic Bone Graft

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, 35516, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 13, 2026
• First Posted: October 21, 2026
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)