A Novel Approach for Horizontal Augmentation: A Split Box

NCT ID: NCT06177899

Last Updated: 2023-12-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 41 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-20
• Study Completion Date: 2023-10-15

Brief Summary

The goal of this clinical study is to investigate the effectiveness of the split-box technique in systemically healthy, non-smoking, over 18 years of age, participants with narrow crests (<5mm bone width) and adequate bone height (>12mm). The main questions it aims to answer are:

• The primary objective of the present study is to investigate the effectiveness of the split-box technique by evaluating the change in width and height of the alveolar bone.
• The secondary objective is to evaluate the superiority of the split-box technique and its modifications in terms of the amount of bone gain.

According to the 3D topography of the alveolar ridge of the patients before augmentation, split box or one of its modifications, reverse split box or sliding split box techniques were selected and applied. (split box was applied if the bone thickness was more than 3 mm at the top of the crest and did not increase towards the lower border at the alveolar bone, reverse split box technique was applied if the bone thickness was more than 3 mm at the top of the crest and increased towards the lower border at the alveolar bone, sliding split box was applied if the bone thickness was less than 3 mm at the top of the crest but the bone thickness increases towards the lower border at the alveolar bone.)

Conditions

Alveolar Bone Loss; Alveolar Ridge Augmentation; Augmentation, Alveolar Ridge

Keywords

Alveolar ridge augmentation; Horizontal augmentation; Bone block augmentation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Split-box group

Before augmentation, according to the 3D topography of the alveolar ridge of the patients, the split-box technique was applied if there was more than 3 mm bone thickness at the top of the crest and the bone thickness did not increase towards the lower border.

All surgical procedures were performed under local anesthesia. A mid-crestal incision was made along the ridge crest and two vertical incisions were made at the termination of the crestal incision. All osteotomies were made using with piezoelectric surgery. Horizontal and vertical osteotomies were performed 1.5 mm away from adjacent teeth. Lower border osteotomy of the vestibular cortical bone was performed. A chisel osteoma was used to separate completely and mobilize the segmented bone. This separated, corticocancellous block was stabilized on the distance to the native alveolar crest with micro screws. The space between the block and the alveolar crest was filled with allograft. The flaps were closed using 3-0,4-0 vicryl.

Splitting of bone and fixation of bone laminae differ between the 3 groups.

Intervention Type: PROCEDURE

In split-box technique, all osteotomies were made using with piezoelectric surgery. Horizontal and vertical osteotomies were performed 1.5 mm away from adjacent teeth. Lower border osteotomy of the vestibular cortical bone was performed. A chisel osteoma was used to separate completely and mobilize the segmented bone. This separated, corticocancellous block was stabilized on the distance to the native alveolar crest with micro screws. The space between the block and the alveolar crest was filled with allograft. In reverse split box technique, differs from the split-box technique as follows: it involves reversing the separated corticocancellous bone block before fixation. In sliding split box technique, differs from the split-box technique as follows: horizontal osteotomy is performed at the level where the bone thickness reaches at least 3 mm. Separated corticocancellous bone block is slid toward the coronal of alveolar crest and fixed in line with the native alveolar bone.

Reverse split-box group

Before augmentation, according to the 3D topography of the alveolar ridge of the patients, the reverse split-box technique was applied if there was more than 3 mm bone thickness at the top of the crest and the bone thickness increase towards the lower border.

This technique differs from the split-box technique as follows: If the bone thickness of the alveolar crest is thick enough to be split, in addition to the bone thickness increases toward the lower border at the alveolar bone, it involves reversing the separated corticocancellous bone block before fixation.

Splitting of bone and fixation of bone laminae differ between the 3 groups.

Intervention Type: PROCEDURE

In split-box technique, all osteotomies were made using with piezoelectric surgery. Horizontal and vertical osteotomies were performed 1.5 mm away from adjacent teeth. Lower border osteotomy of the vestibular cortical bone was performed. A chisel osteoma was used to separate completely and mobilize the segmented bone. This separated, corticocancellous block was stabilized on the distance to the native alveolar crest with micro screws. The space between the block and the alveolar crest was filled with allograft. In reverse split box technique, differs from the split-box technique as follows: it involves reversing the separated corticocancellous bone block before fixation. In sliding split box technique, differs from the split-box technique as follows: horizontal osteotomy is performed at the level where the bone thickness reaches at least 3 mm. Separated corticocancellous bone block is slid toward the coronal of alveolar crest and fixed in line with the native alveolar bone.

Sliding split-box group

Before augmentation, according to the 3D topography of the alveolar ridge of the patients, the sliding split-box technique was applied if there was less than 3 mm bone thickness at the top of the crest and the bone thickness increase towards the lower border.

This technique differs from the split-box technique as follows: If the bone thickness of the alveolar crest is not thick enough to split at the alveolar crest (<3 mm), but the bone thickness increases toward the lower border of the alveolar bone, horizontal osteotomy is performed at the level where the bone thickness reaches at least 3 mm. Separated corticocancellous bone block is slid toward the coronal of alveolar crest and fixed in line with the native alveolar bone.

Splitting of bone and fixation of bone laminae differ between the 3 groups.

Intervention Type: PROCEDURE

In split-box technique, all osteotomies were made using with piezoelectric surgery. Horizontal and vertical osteotomies were performed 1.5 mm away from adjacent teeth. Lower border osteotomy of the vestibular cortical bone was performed. A chisel osteoma was used to separate completely and mobilize the segmented bone. This separated, corticocancellous block was stabilized on the distance to the native alveolar crest with micro screws. The space between the block and the alveolar crest was filled with allograft. In reverse split box technique, differs from the split-box technique as follows: it involves reversing the separated corticocancellous bone block before fixation. In sliding split box technique, differs from the split-box technique as follows: horizontal osteotomy is performed at the level where the bone thickness reaches at least 3 mm. Separated corticocancellous bone block is slid toward the coronal of alveolar crest and fixed in line with the native alveolar bone.

Interventions

Splitting of bone and fixation of bone laminae differ between the 3 groups.

In split-box technique, all osteotomies were made using with piezoelectric surgery. Horizontal and vertical osteotomies were performed 1.5 mm away from adjacent teeth. Lower border osteotomy of the vestibular cortical bone was performed. A chisel osteoma was used to separate completely and mobilize the segmented bone. This separated, corticocancellous block was stabilized on the distance to the native alveolar crest with micro screws. The space between the block and the alveolar crest was filled with allograft. In reverse split box technique, differs from the split-box technique as follows: it involves reversing the separated corticocancellous bone block before fixation. In sliding split box technique, differs from the split-box technique as follows: horizontal osteotomy is performed at the level where the bone thickness reaches at least 3 mm. Separated corticocancellous bone block is slid toward the coronal of alveolar crest and fixed in line with the native alveolar bone.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• To be older than 18 years of age
• To be systemically healthy
• To be non-smokers
• Having narrow crests (<5 mm bone width)
• Having adequate bone height (>12 mm)
• Having cone-beam computed tomography scans before surgery and five months after augmentation

Exclusion Criteria

• Having bone diseases,
• A history of neck or head radiotherapy
• Receiving steroids, bisphosphonates or chemotherapeutic drugs
• Being pregnancy
• Having narrow bone thickness in the crest (<3 mm), those in whom this thickness did not increase toward the lower border of the alveolar bone
• Patients with a history of infection or exposure after augmentation

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 73 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Marmara University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

spltbx

Identifier Type: -

Identifier Source: org_study_id