Horizontal Ridge Augmentation Using Sausage Technique: A... | NCT07041398

Studies
Horizontal Ridge Augmentation Using Sausage Technique: A Retrospective Study

NCT07041398

Sponsor

Kocaeli University

Status

Completed

Last Update Posted

Jun 27, 2025Actual

Enrollment

23Actual

Phase

Not provided

Conditions

Alveolar Bone Grafting
Guided Bone Regeneration
Bone Gain

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2024Actual

Primary Completion Date

Jun 3, 2024Actual

Completion Date

Jun 10, 2024Actual

First Submitted Date

Jun 19, 2025

First Submission Date that Met QC Criteria

Jun 19, 2025

First Posted Date

Jun 27, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2025

Last Update Posted Date

Jun 27, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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). 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amount of horizontal bone gain postoperatively		Within1 week after the collection of patient data
Amount of horizontal bone resorption postoperatively		Within 5 to 7 months postoperatively
Amount of vertical bone resorption postoperatively		Within 5 to 7 months postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample