Alveolar Bone GraftingNCT07041398
Horizontal Ridge Augmentation Using Sausage Technique: A Retrospective Study
An observational study of Alveolar Bone Grafting and Guided Bone Regeneration, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
This retrospective study investigates the outcomes of the sausage technique, a contemporary modification of guided bone regeneration (GBR), for the augmentation of severely horizontally deficient alveolar ridges (<4 mm width). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Bone Grafting, Guided Bone Regeneration, Bone Gain
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2024to 10 Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this study, patient follow-up forms and cone-beam computed tomography (CBCT) scans taken during the pre- and postoperative periods were retrospectively reviewed from the archive of the Department of Oral and Maxillofacial Surgery at Kocaeli University Faculty of Dentistry. All procedures had been performed by the same team (B.T. and Z.D.). Among these records, patients who presented with total or partial edentulism in either jaw and received the sausage technique to treat horizontal alveolar bone deficiency were selected for inclusion.
Who may be able to join
- Patients with knife-edge alveolar ridges, classified as Class IV according to the Cawood and Howell classification, who underwent ridge augmentation using the sausage technique
- Patients aged 18 or older with fully developed bone
- Patients who had regular clinical and radiographic follow-up after the procedure, with a minimum follow-up period of six months
Who cannot join
- Patients with systemic conditions (such as osteoporosis, cancer, immunosuppression, hyperparathyroidism, or hyperthyroidism) or a history of medications (including intravenous or oral bisphosphonates, immunosuppressants, or chemotherapy) that could interfere with bone healing
- Patients with a history of radiotherapy to the head or neck region
- Patients classified as ASA III or ASA IV
- Patients who were active smokers at the time of surgery
- Patients whose pre- or postoperative CBCT scans were of low image quality or affected by artefacts
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University Faculty of Dentistry
Kocaeli, Başiskele, 41040
About this study
This retrospective study investigates the outcomes of the sausage technique, a contemporary modification of guided bone regeneration (GBR), for the augmentation of severely horizontally deficient alveolar ridges (<4 mm width). The technique, originally introduced by Urban and colleagues, uses multiple fixation pins to enhance membrane stability and maintain graft volume through a tension dome effect.
In this study, a total of 23 patients underwent horizontal ridge augmentation using the sausage technique, with bone measurements assessed at 2, 4, and 6 mm apical to the crest using CBCT imaging at preoperative (T0), early postoperative (T1), and late postoperative (T2) stages. The study quantitatively analyzed both horizontal bone gain (T2-T0) and bone resorption (T1-T2) during the healing period.
- Conditions
- Alveolar Bone Grafting, Guided Bone Regeneration, Bone Gain
- Keywords
- Alveolar bone augmentation, Dental implant, Guided bone regeneration, Horizontal bone gain, Sausage technique
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of horizontal bone gain postoperatively
Measured: Within1 week after the collection of patient data
Amount of horizontal bone resorption postoperatively
Measured: Within 5 to 7 months postoperatively
Amount of vertical bone resorption postoperatively
Measured: Within 5 to 7 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start2 Jan 2024
- Primary completion3 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone GraftingStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berkay Tokuç, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041398
- Sponsor's protocol ID
- 2023/384
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Horizontal Ridge Augmentation Using Sausage Technique: A Retrospective Study
- ClinicalTrials.gov ID
- NCT07041398
- Acronym / sponsor ID
- 2023/384
- Conditions
- Alveolar Bone Grafting, Guided Bone Regeneration, Bone Gain
- Keywords
- Alveolar bone augmentation, Dental implant, Guided bone regeneration, Horizontal bone gain, Sausage technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 27 Jun 2025 (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.
This retrospective study investigates the outcomes of the sausage technique, a contemporary modification of guided bone regeneration (GBR), for the augmentation of severely horizontally deficient alveolar ridges (<4 mm width). The technique, originally introduced by Urban and colleagues, uses multiple fixation pins to enhance membrane stability and maintain graft volume through a tension dome effect.
In this study, a total of 23 patients underwent horizontal ridge augmentation using the sausage technique, with bone measurements assessed at 2, 4, and 6 mm apical to the crest using CBCT imaging at preoperative (T0), early postoperative (T1), and late postoperative (T2) stages. The study quantitatively analyzed both horizontal bone gain (T2-T0) and bone resorption (T1-T2) during the healing period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, patient follow-up forms and cone-beam computed tomography (CBCT) scans taken during the pre- and postoperative periods were retrospectively reviewed from the archive of the Department of Oral and Maxillofacial Surgery at Kocaeli University Faculty of Dentistry. All procedures had been performed by the same team (B.T. and Z.D.). Among these records, patients who presented with total or partial edentulism in either jaw and received the sausage technique to treat horizontal alveolar bone deficiency were selected for inclusion.
Key inclusion criteria (3 listed)
- Patients with knife-edge alveolar ridges, classified as Class IV according to the Cawood and Howell classification, who underwent ridge augmentation using the sausage technique
- Patients aged 18 or older with fully developed bone
- Patients who had regular clinical and radiographic follow-up after the procedure, with a minimum follow-up period of six months
Key exclusion criteria (5 listed)
- Patients with systemic conditions (such as osteoporosis, cancer, immunosuppression, hyperparathyroidism, or hyperthyroidism) or a history of medications (including intravenous or oral bisphosphonates, immunosuppressants, or chemotherapy) that could interfere with bone healing
- Patients with a history of radiotherapy to the head or neck region
- Patients classified as ASA III or ASA IV
- Patients who were active smokers at the time of surgery
- Patients whose pre- or postoperative CBCT scans were of low image quality or affected by artefacts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Amount of horizontal bone gain postoperatively
Time frame: Within1 week after the collection of patient data
Amount of horizontal bone resorption postoperatively
Time frame: Within 5 to 7 months postoperatively
Amount of vertical bone resorption postoperatively
Time frame: Within 5 to 7 months postoperatively
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 27 Jun 2025.
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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 Grafting and Guided Bone Regeneration, run by Kocaeli 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 3 inclusion and 5 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 27 Jun 2025. 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?
Amount of horizontal bone gain postoperatively (time frame: Within1 week after the collection of patient data). The study lists 3 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 27 Jun 2025.