- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07436533
Osseodensification for Narrow Alveolar Ridge Expansion (OD-RridgeExp)
Expansion of Narrow Alveolar Ridge by Osseodensification A Prospective Clinical Study
This prospective clinical study aims to evaluate the effectiveness of osseodensification in expanding narrow alveolar ridges during dental implant site preparation. Alveolar ridge deficiency is a common clinical challenge that may complicate implant placement. Osseodensification is a minimally invasive drilling technique that preserves and compacts bone rather than removing it, potentially allowing simultaneous ridge expansion and implant placement.
In this study, patients presenting with narrow alveolar ridges indicated for dental implant placement will be treated using Densah burs operating in a non-extractive (densifying) mode. Ridge width will be measured directly using standardized Micro Castroviejo bone calipers at two reference levels: at the crestal bone level and at 5mm, at 10 mm apical to the crest. Measurements will be recorded immediately before and immediately after osseodensification.
The primary objective is to assess the dimensional changes in ridge width achieved through osseodensification without the use of additional ridge augmentation procedures. The study focuses solely on within-subject comparison (pre- and post-expansion measurements) and does not compare this technique to other ridge expansion methods.
The results are expected to provide clinical evidence regarding the amount of horizontal ridge expansion achievable using osseodensification and its applicability in managing narrow alveolar ridges for implant therapy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective clinical study follows a standardized protocol for alveolar ridge expansion using osseodensification. After local anesthesia and reflection of a full-thickness mucoperiosteal flap, the initial bone width is measured at the crest (0 mm) and 5 mm apical to the crest using Micro Castroviejo Bone Calipers.
The implant site preparation begins with a pilot drill, followed by the use of densifying burs (e.g., Densah Burs) in a counter-clockwise direction (non-subtractive mode) with copious irrigation. This technique allows for lateral condensation and expansion of the bone as the burs advance. After reaching the final desired diameter, the bone width is measured again at the same two levels (0 mm and 5 mm) to record the expansion gain.
Finally, the dental implant is placed, and primary stability is recorded using Insertion Torque . Post-operative care and follow-up follow standard dental implant protocols
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Essam Ali AL-saidi, BDS
- Phone Number: 00967 770982890 - 00967 771699
- Email: asdentme@gmail.com
Study Contact Backup
- Name: Abdalwahab Yahya Aldailami, PhD
- Phone Number: 00967 777781033
Study Locations
-
-
S
-
Sanaa, S, Yemen, (15201 - 13064)
- Recruiting
- 60 Meters St., Madbah, University of Science and Technology
-
Contact:
- Essam Ali AL-saidi, BDS
- Phone Number: 00967 770982890
- Email: asdentme@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 18 years or older, including both genders.
- Healed edentulous sites (short or long spans, single or multiple missing teeth) in maxillary or mandibular arches.
- At least 6 months post-extraction period (delayed implant placement).
- Alveolar ridge width of 3-5 mm at the crest (buccolingually).
- Low-density jaw regions (D1-D5 according to Misch classification).
- Presence of ≥ 2 mm trabecular bone core and trabecular-to-cortical bone ratio of ≥ 1:1.
- Sufficient vertical dimensions as assessed via CBCT.
- Straightforward cases according to SAC classification (Beagle, 2013).
- Well-motivated patients willing to attend follow-up visits and maintain good oral hygiene.
Exclusion Criteria:
- Acute or chronic infection or pathological condition at the proposed implant site.
- Severe buccal plate undercut or concavity.
- Signs of active infection in the implant zone.
- Severe parafunctional habits such as bruxism or clenching.
- Heavy smoking (more than 10 cigarettes per day).
- Inadequate inter-ridge distance or insufficient vertical height for implant placement.
- Use of medications compromising bone healing (e.g., corticosteroids, hormone replacement therapy, or bisphosphonates).
- Uncontrolled systemic diseases (e.g., diabetes, immunocompromised states, hyperparathyroidism, or fibrous dysplasia).
- History of radiotherapy to the head/neck or chemotherapy within the past 5 years.
- Current pregnancy during the surgical procedure.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: osseodensification Group
Participants with narrow alveolar ridges indicated for dental implant placement will undergo implant site preparation using the osseodensification technique.
After flap elevation, baseline ridge width measurements will be obtained at the crestal level at 5mm and 10 mm apical to the crest using standardized Micro Castroviejo bone calipers.
Osteotomy preparation will then be performed using Densah burs operating in densifying mode according to the manufacturer's recommended protocol.
Following completion of osteotomy preparation and prior to implant insertion, ridge width measurements will be repeated at the same reference points.
The primary evaluation consists of within-subject comparison of pre- and post-osseodensification ridge width measurements.
|
Implant site preparation using Densah burs in counterclockwise (densifying) mode to achieve bone compaction and horizontal ridge expansion without additional grafting procedures
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
alveolar Ridge Width Change After Osseodensification
Time Frame: Intraoperative assessment (immediately before and immediately after osseodensification during the same surgical procedure)
|
Change in alveolar ridge width (in millimeters) measured directly using standardized Micro Castroviejo bone calipers at two reference levels: (1) crestal bone level and (2) 5 mm apical to the crest(3)10 mm apical to the crest.
Measurements are recorded immediately before osteotomy preparation and immediately after completion of osseodensification, prior to implant placement.
The primary endpoint is the within-subject difference (post-osseodensification minus pre-osseodensification) in ridge width at both levels.
|
Intraoperative assessment (immediately before and immediately after osseodensification during the same surgical procedure)
|
Collaborators and Investigators
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
Other Study ID Numbers
- 1446/0042/UREC/UST
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.
Clinical Trials on Osseodensification
-
Ain Shams UniversityNot yet recruiting
-
Hams Hamed AbdelrahmanCompletedDental Implant | OsseodensificationEgypt
-
University of Dublin, Trinity CollegeRecruiting
-
Ordu UniversityCompletedDental Implants | Osseodensification Drilling TechniqueTurkey (Türkiye)
-
Delta University for Science and TechnologyMansoura UniversityCompleted
-
Mohamad Ali ItaniBeirut Arab UniversityEnrolling by invitationImmediate Dental Implant Placement | Conventional Drilling Technique | Osseodensification Drilling TechniqueLebanon
-
Cairo UniversityNot yet recruitingPrimary Stability of Knife Threads Dental Implant Versus Double Threads Using Osseodensification Technique
-
King Khalid UniversityNot yet recruitingEvaluation of Osseointegration and Stability of Dental Implants in Bone Density Enhanced by Osseodensification Technique
-
University of MosulEnrolling by invitationDental Implant | Alveolar Bone Loss | Osseodensification Drilling TechniqueIraq
Clinical Trials on Densah burs (Osseodensification Technique)
-
Suez Canal UniversityNot yet recruitingPatient With Low Denisty Bone
-
University of BaghdadCompleted
-
Mansoura UniversityCompleted
-
University of Dublin, Trinity CollegeRecruiting
-
Mohamed Magdy Mostafa ShehataCairo UniversityCompleted
-
Mohamad Ali ItaniBeirut Arab UniversityEnrolling by invitationImmediate Dental Implant Placement | Conventional Drilling Technique | Osseodensification Drilling TechniqueLebanon
-
Mohammed Bin Rashid University of Medicine and...Active, not recruitingDental Implant Failed | Edentulous Alveolar Ridge | Jaw, Edentulous, Partially | Osseointegration Failure of Dental ImplantUnited Arab Emirates
-
Jackson Implant SurgeryCompleted
-
Hams Hamed AbdelrahmanCompletedDental Implant | OsseodensificationEgypt
-
University of BaghdadCompletedDental Implant Failed | Bone Infection | Bone FractureIraq