Single vs. Double Tenting Screws for Horizontal Ridge Augmentation.

NCT ID: NCT07060027

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-12-10

Brief Summary

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:

• Does using two screws give better bone growth than using one screw?
• Which technique creates more stable bone for dental implants?

Researchers will compare the single-screw technique to the double-screw technique to see which works better for jawbone reconstruction.

Participants will:

• Receive either one or two small titanium screws placed in their jawbone to support a bone graft
• Have the graft covered with a protective membrane
• Return after 6 months for screw removal and dental implant placement
• Attend follow-up visits to check healing progress

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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Conditions

Bone Defects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Single tenting screw

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

Group Type: EXPERIMENTAL

horizontal bone augmentation using single tenting screw

Intervention Type: 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.

Double tenting screw

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.

Group Type: ACTIVE_COMPARATOR

horizontal bone augmentation using Double tenting screw

Intervention Type: 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.

Interventions

horizontal bone augmentation using single tenting screw

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.

Intervention Type: PROCEDURE

horizontal bone augmentation using Double tenting screw

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients are systemically healthy based on questionnaire dental modification of Cornell index (Bolender, C. L. et al., 1969).
• Gingival health according to the new classification system (Caton, J. G. et al., 2018).
• The recipient site of the augmentation is free from any pathological conditions.
• At least 1 tooth area with a ridge defect and planned to receive a dental implant. The site must be bordered by at least 1 tooth.
• Class I ridge defect according to Seibert's classification.
• Adequate interocclusal space to accommodate the available restorative components.

Exclusion Criteria

• Parafunctional habits such as bruxism and clenching
• Smokers
• Pregnant females

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Omar Saad

OTHER

Sponsor Role: lead

Responsible Party

Omar Saad

Principal Investigator - Teaching Assistant of Periodontology, Faculty of dentistry, Minia university

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

hospital of faculty of dentistry, Minia university

Minya, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

4/626/88/2022

Identifier Type: -

Identifier Source: org_study_id