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The goal of this clinical trial is to learn if using two screws works better than one screw for building up jawbone width before dental implant placement. It will also check the safety of both techniques. The main questions it aims to answer are:
Researchers will compare the single-screw technique to the double-screw technique to see which works better for jawbone reconstruction.
Participants will:
The study will help dentists determine the best method for patients who need jawbone reconstruction before getting dental implants. All procedures use FDA-approved materials and follow standard surgical protocols.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single tenting screw | Experimental | 8 patients indicated for lateral ridge augmentation in premolar-molar area (class I Seibert's classification) will be candidates to screw tent technique using single screw at crest position |
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| Double tenting screw | Active Comparator | 8 patients indicated for lateral ridge augmentation in premolar-molar area (class I Seibert's classification) will be candidates to screw tent technique using double screws, one at a crestal position and the other one 5 mm apical to the first one. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| horizontal bone augmentation using single tenting screw | Procedure | Patients in this group will undergo guided bone regeneration (GBR) using a single titanium bone screw placed in the crestal position to stabilize the graft material. The surgical procedure includes sulcular and vertical releasing incisions, elevation of full-thickness buccal and palatal/lingual flaps, and multiple cortical perforations to enhance angiogenesis. The defect will be filled with particulate allograft extended 10-12 mm apicocoronally and covered with a bovine pericardium membrane. A tension-free primary closure will be achieved using 5-0 polypropylene sutures. Bone screw removal and implant placement will occur 6 months postoperatively. This group is distinguished by the use of a single crestal screw for graft stabilization compared to dual-screw fixation in the control group. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Horizontal Ridge Width at Mid-Crestal Level | Ridge width will be measured at the mid-crestal level using a bone caliper to the nearest millimeter. A standardized stent will ensure consistent measurement positioning. | 6 months post-intervention |
| Change in Horizontal Ridge Width 5 mm Apical to Crest | Ridge width will be measured 5 mm apical to the crestal level using a bone caliper to the nearest millimeter. The same stent will standardize measurements. | 6 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Keratinized Mucosa Width at 6 Months Post-Reentry | The width of keratinized mucosa will be measured using a periodontal probe to the nearest millimeter at the reentry procedure, 6 months after the initial intervention. The same stent will be used to standardize measurements. | 6 months post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| hospital of faculty of dentistry, Minia university | Minya | 61512 | Egypt |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 1, 2022 | Jul 1, 2025 | Prot_000.pdf |
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| horizontal bone augmentation using Double tenting screw | Procedure | Participants in this group will receive guided bone regeneration (GBR) with two titanium bone screws for enhanced graft stabilization. One screw will be placed at the crestal level, while a second screw will be inserted 5 mm apical to the first, providing vertical stabilization of the graft material. The procedure involves sulcular and vertical releasing incisions, full-thickness flap elevation on both buccal and palatal/lingual aspects, and multiple cortical perforations to stimulate vascularization. The defect will be filled with particulate allograft extending 10-12 mm apicocoronally and covered with a bovine pericardium membrane. Tension-free primary closure will be performed using 5-0 polypropylene sutures. At 6 months, screws will be removed and dental implants placed. This intervention is distinguished by the dual-screw fixation technique, designed to provide greater mechanical stability compared to the single-screw approach used in the comparator group. |
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| Change in Alveolar Ridge Width via CBCT at 6 Months |
Cone-beam computed tomography (CBCT) will be used to assess changes in ridge width at 6 months post-intervention |
| 6 months post-intervention |
| Change in Bone Density via CBCT at 6 Months | CBCT imaging will assess bone density changes (in Hounsfield units or grayscale values) at the treated site after 6 months. | 6 months post-intervention |