Clinical trial NCT06177899: A Novel Approach for Horizontal Augmentation: A Split Box
Official title: A Novel Approach for Horizontal Augmentation With Split Box: A Method That Combines Split Bone Block and Ridge Split Techniques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alveolar Bone Loss
Alveolar Ridge Augmentation
Augmentation, Alveolar Ridge
Keywords: Alveolar ridge augmentation
Horizontal augmentation
Bone block augmentation
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 41
Sex: ALL
Minimum age (years): 22
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients whose thickness at the top of the alveolar crest is insufficient for implant placement and who require bone augmentation.

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.)


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

Primary outcomes:
measure: Horizontal changes in the alveolar bone
timeFrame: 5 months
measure: Vertical changes in the alveolar bone
timeFrame: 5 months
Secondary outcomes:
measure: Difference in bone thickness gain at the top of the crest (CW) between the 3 groups
timeFrame: 5 months
measure: Difference in bone thickness gain at the top of the screw level (SLW) between the 3 groups
timeFrame: 5 months
measure: Difference in bone loss at alveolar ridge height (ARH) between 3 groups
timeFrame: 5 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
References: