- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07670559
Carrot Technique Versus Guided Bone Regeneration for Horizontal Ridge Deficiency in the Maxillary Esthetic Zone
Evaluation of the Carrot Technique With Simultaneous Implant Placement for Horizontal Alveolar Ridge Deficiency in the Maxillary Aesthetic Zone: A Randomized Controlled Clinical Trial.
Study Overview
Status
Intervention / Treatment
Detailed Description
The Carrot Technique is a minimally invasive approach that utilizes an autogenous bone core harvested during implant osteotomy and repositioned to augment the deficient buccal ridge. This technique may reduce donor-site morbidity while providing sufficient horizontal bone augmentation. Guided Bone Regeneration remains one of the most widely used techniques for horizontal ridge reconstruction through the use of bone substitute materials and barrier membranes.
This randomized controlled clinical trial will compare the clinical and radiographic outcomes of the Carrot Technique and GBR in patients presenting with horizontal ridge deficiency in the maxillary esthetic zone. Twenty patients requiring single-tooth implant rehabilitation will be randomly allocated into two equal groups. Group I will receive implant placement combined with the Carrot Technique, while Group II will receive implant placement combined with Guided Bone Regeneration.
Clinical evaluations will include implant stability assessed by resonance frequency analysis, soft tissue healing using the Landry Healing Index, and peri-implant inflammation using the modified sulcus bleeding index. Radiographic evaluation will be performed using cone beam computed tomography immediately after surgery and at 6 and 12 months postoperatively to assess changes in alveolar ridge width, bone density, and marginal bone loss. The study aims to determine whether the Carrot Technique provides comparable or superior outcomes to GBR for horizontal ridge augmentation associated with implant placement.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Al Mansurah, Egypt
- Faculty of Dentistry, Mansoura University
-
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Dakahlia Governorate
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Al Mansurah, Dakahlia Governorate, Egypt, 35511
- Faculty of Dentistry, Mansoura University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 18 to 45 years. Missing a single tooth in the maxillary esthetic zone requiring implant placement.
Good oral hygiene and patient compliance. Medically free from systemic diseases that contraindicate implant surgery. Slight to moderate horizontal alveolar ridge deficiency with a minimum ridge width of 5 mm.
Adequate vertical bone height for implant placement. Medium to hard bone quality (D2-D3 according to Misch classification). Absence of bruxism or other parafunctional habits.
Exclusion Criteria:
- Presence of local pathological lesions (e.g., cysts or tumors) at the planned surgical site.
Poor bone quality (D4 bone). Pregnancy. Heavy smoking. Any medical condition contraindicating implant surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Carrot Technique
Implant placement with horizontal ridge augmentation using an autogenous bone core harvested with a trephine drill from the implant osteotomy site and fixed buccally using osteosynthesis screws.
|
Implant placement with simultaneous horizontal ridge augmentation using an autogenous bone core harvested from the implant osteotomy site with a trephine drill and fixed buccally using osteosynthesis screws.
|
|
Active Comparator: Guided Bone Regeneration
Implant placement with horizontal ridge augmentation using bone substitute material and a collagen membrane according to guided bone regeneration principles.
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Implant placement with simultaneous horizontal ridge augmentation using bone substitute material and a collagen membrane according to guided bone regeneration principles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Alveolar Ridge Width
Time Frame: baseline and 12 Months
|
Horizontal alveolar ridge width measured using cone beam computed tomography (CBCT).
Changes in ridge width will be calculated by comparing measurements obtained immediately after surgery and at follow-up.
|
baseline and 12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Marginal Bone Loss
Time Frame: 12 Months
|
Marginal bone loss measured radiographically using CBCT using the implant as a reference.
|
12 Months
|
|
Soft Tissue Healing
Time Frame: 1 Week, 2 Weeks, and 1 Month
|
Soft tissue healing assessed using the Landry Healing Index.
|
1 Week, 2 Weeks, and 1 Month
|
|
Modified Sulcus Bleeding Index
Time Frame: 1 Month and 12 Months
|
Peri-implant soft tissue inflammation assessed using the Modified Sulcus Bleeding Index (mBI).
|
1 Month and 12 Months
|
|
Bone Density
Time Frame: 12 Months
|
Buccal peri-implant bone density measured using CBCT and expressed in Hounsfield Units.
|
12 Months
|
|
Implant Stability Quotient (ISQ)
Time Frame: At implant placement and 12 months
|
Implant stability assessed using resonance frequency analysis and expressed as Implant Stability Quotient (ISQ).
|
At implant placement and 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sarah A Elmaghraby, Faculty of Dentistry, Mansoura University, Mansoura, Egypt
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R.26.02.103
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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