Alveolar Bone LossNCT06177899
A Novel Approach for Horizontal Augmentation: A Split Box
An observational study of Alveolar Bone Loss and Alveolar Ridge Augmentation, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 22 to 73 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss, Alveolar Ridge Augmentation, Augmentation, Alveolar Ridge
- What is being tested?
- Splitting of bone and fixation of bone laminae differ between the 3 groups.
- Type of treatment
- Surgery or procedure
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2023to 15 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 73 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients whose thickness at the top of the alveolar crest is insufficient for implant placement and who require bone augmentation.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Approach for Horizontal Augmentation With Split Box: A Method That Combines Split Bone Block and Ridge Split Techniques
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.)
- Being tested
- Splitting of bone and fixation of bone laminae differ between the 3 groups.
- Keywords
- Alveolar ridge augmentation, Horizontal augmentation, Bone block augmentation
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Splitting of bone and fixation of bone laminae differ between the 3 groups.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Splitting of bone and fixation of bone laminae differ between the 3 groups. | |
| 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. Receives: Procedure: Splitting of bone and fixation of bone laminae differ between the 3 groups. | |
| 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. Receives: Procedure: Splitting of bone and fixation of bone laminae differ between the 3 groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal changes in the alveolar bone
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.
Measured: 5 months
Vertical changes in the alveolar bone
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.
Measured: 5 months
Secondary outcomes (3)
Difference in bone thickness gain at the top of the crest (CW) between the 3 groups
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.
Measured: 5 months
Difference in bone thickness gain at the top of the screw level (SLW) between the 3 groups
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.
Measured: 5 months
Difference in bone loss at alveolar ridge height (ARH) between 3 groups
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start20 Jan 2023
- Primary completion15 Sep 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177899
- Sponsor's protocol ID
- spltbx
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach for Horizontal Augmentation With Split Box: A Method That Combines Split Bone Block and Ridge Split Techniques
- ClinicalTrials.gov ID
- NCT06177899
- Acronym / sponsor ID
- spltbx
- Keywords
- Alveolar ridge augmentation, Horizontal augmentation, Bone block augmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Split-box group | – | Procedure: 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. |
| Reverse split-box group | – | Procedure: 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. |
| Sliding split-box group | – | Procedure: 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. |
Who may qualify
- Ages
- 22 to 73 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients whose thickness at the top of the alveolar crest is insufficient for implant placement and who require bone augmentation.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Reverse split-box group, Sliding split-box group, Split-box group |
Primary outcome
Horizontal changes in the alveolar bone
Time frame: 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.
Vertical changes in the alveolar bone
Time frame: 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.
3 secondary outcomes
Difference in bone thickness gain at the top of the crest (CW) between the 3 groups
Time frame: 5 months
Difference in bone thickness gain at the top of the screw level (SLW) between the 3 groups
Time frame: 5 months
Difference in bone loss at alveolar ridge height (ARH) between 3 groups
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alveolar Bone Loss and Alveolar Ridge Augmentation, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal changes in the alveolar bone (time frame: 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.