A Novel Approach for Horizontal Augmentation: A Split Box

Completed

• Conditions: Alveolar Bone Loss; Alveolar Ridge Augmentation; Augmentation, Alveolar Ridge
• Interventions: Procedure: Splitting of bone and fixation of bone laminae differ between the 3 groups.

• Registration Number: NCT06177899
• Lead Sponsor: Marmara University

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.)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-20
• Primary Completion: 2023-09-15
• Study Completion: 2023-10-15
• Status Verified: 2023-12
• Study First Submitted: 2023-12-11
• Study First Submitted QC: 2023-12-11
• Last Update Submitted: 2023-12-11
• Study First Posted: 2023-12-20
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Reverse split-box group	Splitting of bone and fixation of bone laminae differ between the 3 groups.	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.
Split-box group	Splitting of bone and fixation of bone laminae differ between the 3 groups.	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.
Sliding split-box group	Splitting of bone and fixation of bone laminae differ between the 3 groups.	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.

Primary Outcome Measures

Name	Time	Method
Vertical changes in the alveolar bone	5 months	To determine whether there was vertical bone loss during horizontal augmentation, the height of the alveolar ridge (ARH) was measured. To measure ARH, a line was created between the anatomical landmark and the highest point of the crest, and the length of this line was measured in the pre- and post-operative tomography.
Horizontal changes in the alveolar bone	5 months	To determine the horizontal changes in the alveolar bone, thickness was measured at two different levels. The measurements were titled as follows: crestal width (CW) and screw level width (SLW).; To measure CW, measurements were made horizontally at the highest point of the crest in pre- and post-operative tomography. To measure SLW, in the post-operative tomography, the bone thickness at the screw level was measured horizontally and recorded. In addition, the distance between the anatomical landmark (mandibular basis, mandibular foramen, lower border of nasal or sinus cavity) and the screw level was also measured and recorded. The main goal of this measurement was to provide a reference for SLW measurement on preoperative cone-beam computed tomography (CBCT), since there were no screws. After the measurements in the postoperative CBCT were made, SLW was also made in the preoperative imaging.

Secondary Outcome Measures

Name	Time	Method
Difference in bone thickness gain at the top of the crest (CW) between the 3 groups	5 months	In order to determine the difference between the 3 groups in terms of CW, the difference between the pre- and post-operative values of the 3 groups was determined. These values were compared between the 3 groups.
Difference in bone loss at alveolar ridge height (ARH) between 3 groups	5 months	In order to determine the difference between the 3 groups in terms of ARH, the difference between the pre- and post-operative values of the 3 groups was determined. These values were compared between the 3 groups.
Difference in bone thickness gain at the top of the screw level (SLW) between the 3 groups	5 months	In order to determine the difference between the 3 groups in terms of SLW, the difference between the pre- and post-operative values of the 3 groups was determined. These values were compared between the 3 groups.

Trial Locations

Locations (1)

Marmara University; 🇹🇷 Istanbul, Turkey