- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07272694
Split Crest Procedure: Is It Necessary to Fill the Gap?
A Prospective Controlled Clinical Study Evaluating the Effect of Bone and Autologous Dentin Grafting in the Osteotomy Gap During the Split Crest Procedure With Simultaneous Implant Placement
This prospective controlled clinical study evaluates the effectiveness of adding bone graft or dentin graft material during the split crest (alveolar ridge splitting) procedure for horizontal ridge augmentation with simultaneous implant placement.
The study includes patients with narrow alveolar ridges requiring implant-supported rehabilitation. Participants are divided into three groups: split crest without grafting, split crest with bone graft, and split crest with dentin graft. The aim is to determine whether the addition of graft material to the osteotomy gap improves bone width, bone density, and primary implant stability compared to the split crest technique alone.
Clinical and radiographic assessments are performed using cone-beam computed tomography (CBCT) and implant stability measurements (ISQ values) before surgery, immediately after implant placement, and three months postoperatively. All patients are monitored over a one-year follow-up period to evaluate healing progression and treatment outcomes.
This study seeks to identify the most effective approach for horizontal ridge augmentation and to improve clinical decision-making in implant dentistry. The findings aim to contribute to optimizing surgical protocols, enhancing implant stability, and improving long-term functional outcomes for patients.
Participation is voluntary, and all procedures are conducted in accordance with approved ethical standards and clinical guidelines.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Pančevo, Serbia, 26000
- Faculty of Stomatology, Department of Oral Surgery, University Business Academy in Novi Sad,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients aged 18-65 years
- Indication for tooth extraction in posterior mandibular region with planned implant placement
- Presence of post-extraction alveolar bone defect requiring ridge preservation procedure
- Good general health (ASA I or ASA II)
- Ability to understand the study procedures and provide written informed consent
- Willingness to comply with scheduled follow-up visits and study protocol
Exclusion Criteria:
- Systemic diseases affecting bone healing (e.g. uncontrolled diabetes, osteoporosis, metabolic bone disorders)
- History of radiotherapy in the head and neck region
- Use of bisphosphonates or other antiresorptive medications
- Active periodontal or periapical infection at the surgical site
- Heavy smokers (>10 cigarettes per day)
- Pregnancy or breastfeeding
- Known allergies to materials used in the study
- Poor oral hygiene or lack of complianc
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Split Crest Only
|
A surgical split crest (alveolar ridge splitting) procedure performed to increase horizontal alveolar bone width and enable simultaneous dental implant placement.
A controlled osteotomy is created along the crest of the ridge, followed by gradual expansion of the buccal cortical plate to form an osteotomy gap for implant insertion.
|
|
Experimental: Split Crest + Bone Graft
|
A surgical split crest (alveolar ridge splitting) procedure performed to increase horizontal alveolar bone width and enable simultaneous dental implant placement.
A controlled osteotomy is created along the crest of the ridge, followed by gradual expansion of the buccal cortical plate to form an osteotomy gap for implant insertion.
|
|
Experimental: Split Crest + Dentin Graft
|
A surgical split crest (alveolar ridge splitting) procedure performed to increase horizontal alveolar bone width and enable simultaneous dental implant placement.
A controlled osteotomy is created along the crest of the ridge, followed by gradual expansion of the buccal cortical plate to form an osteotomy gap for implant insertion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in alveolar ridge width following split crest proceduree with or without bone or dentin grafting
Time Frame: Preoparative, Immediately postoperative, and 3 months after surgery
|
Preoparative, Immediately postoperative, and 3 months after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SC-DENTIN-2024-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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