- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07619846
Using Chin Bone Rings for Sinus Lifting and Dental Implants in One Surgery (BRT-SINUS)
Evaluation of Effectiveness of Bone Ring Technique in One Stage Surgery of External Maxillary Sinus Lifting With Implantation: A Prospective Case Series
Study Overview
Status
Intervention / Treatment
Detailed Description
The Bone Ring Technique (BRT) was introduced by Giesenhagen (2004) to address severe posterior maxillary atrophy. In this prospective single arm case series, after obtaining ethics approval (DN 28102025 542, Damascus University), ten patients with residual bone height ≤4 mm will undergo: harvesting of an 8 mm cylindrical autogenous bone ring from the mandibular symphysis using trephine burs; creation of a lateral window in the maxillary sinus using a straight handpiece with a diamond round bur; meticulous elevation of the Schneiderian membrane; placement of the bone ring; simultaneous insertion of a dental implant (ICX) through the ring into the native ridge; filling of the defect with xenograft (bovine) particles; coverage with a collagen membrane; and suturing Primary stability will be measured immediately after implantation using resonance frequency analysis (Mega ISQ II).
CBCT scans (PaX i3D, VATECH) will be performed preoperatively, at 1 week, and at 6 months to quantify vertical bone gain (distance from implant shoulder to sinus floor) and peri implant bone density (Hounsfield like units).
Clinical follow up includes suture removal at 7 10 days and assessment of implant survival/success at 6 months (absence of mobility, pain, radiolucency, suppuration, crestal bone loss <1.5 mm).
Results will be submitted for publication in a peer reviewed journal.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Adel Alassaf, Resident &MSc candidate in OMF
- Phone Number: +963 949038706
- Email: sx19adel@gmail.com
Study Locations
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-
Governorate
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Damascus, Governorate, Syria, 4671
- Oral and Maxillofacial Surgery Hospital, Faculty of Dentistry, Damascus University, Mezzeh Highway, Damascus, Syria
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1. Need for dental implant in posterior maxilla (premolar/molar). 2. Residual alveolar bone height ≤4 mm on preoperative CBCT. 3. Age ≥18 years. 4. Controlled systemic health. 5. Able to comply with procedures and follow up. 6. Good oral hygiene. 7. Signed written informed consent.
Exclusion Criteria:
- 1. Uncontrolled systemic disease. 2. Head/neck radiotherapy. 3. Bisphosphonate therapy >3 years. 4. Autoimmune disease affecting healing. 5. Pregnancy/lactation. 6. Active maxillary sinus pathology (sinusitis, cysts, polyps, tumours). 7. Heavy smoking (>10 cigarettes/day). 8. Severe bruxism.
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: Bone Ring Technique (BRT)
Eligible patients with posterior maxillary atrophy (RBH ≤4 mm) will undergo a single surgical session.
Preoperatively, CBCT will be performed.
Under local anesthesia, the surgeon will harvest an autogenous bone ring from the chin (mandibular symphysis) using trephine burs.
A lateral window will be created in the maxillary sinus wall using a straight handpiece with a diamond round bur.
The sinus membrane will be elevated, and the bone ring will be placed into the sinus.
A dental implant (ICX) will be inserted through the ring into the residual ridge.
The defect will be filled with xenograft particles and covered with a collagen membrane.
Sutures will be removed at 7-10 days.
Patients will be followed for 6 months with clinical and CBCT evaluations.
|
The Bone Ring Technique (BRT) is a one-stage surgical procedure that combines external maxillary sinus floor elevation with simultaneous dental implant placement.
An autogenous bone ring is harvested from the mandibular symphysis using trephine burs.
The sinus membrane is elevated via a lateral window approach created with a straight handpiece and diamond round bur.
The bone ring is then placed into the sinus cavity, and a dental implant is inserted through the ring into the residual alveolar bone.
The surgical site is augmented with xenograft particles and covered with a collagen membrane.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant Stability Quotient (ISQ).
Time Frame: Immediately after implant placement (baseline) and 6 months post_surgery (before prosthetic loading).
|
Measured by resonance frequency analysis with MEGA ISQ II (MegaGen, Korea), Four readings per implant (mesial, distal, buccal, lingual); mean value reported
|
Immediately after implant placement (baseline) and 6 months post_surgery (before prosthetic loading).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vertical Bone Gain (mm)
Time Frame: at preoperative, 1 week post_surgery , 6 months post_surgery
|
Distance from implant shoulder to highest point of elevated sinus floor; measured on coronal sections using Ez3D plus software
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at preoperative, 1 week post_surgery , 6 months post_surgery
|
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Peri implant Bone Density (gray values)
Time Frame: at preoperative, 1 week post_surgery , 6 months post_surgery
|
regions of interest: coronal, middle, apical thirds
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at preoperative, 1 week post_surgery , 6 months post_surgery
|
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Implant Survival & Success
Time Frame: 6 months post_surgery
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Survival = implant in situ.
Success = absence of mobility, persistent pain, peri implant radiolucency, suppuration; and crestal bone loss <1.5 mm on CBCT.
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6 months post_surgery
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Khaldoun Darwich, professor of OMFS, Damascus University Syria
Publications and helpful links
General Publications
- Omara M, Abdelwahed N, Ahmed M, Hindy M. Simultaneous implant placement with ridge augmentation using an autogenous bone ring transplant. Int J Oral Maxillofac Surg. 2016 Apr;45(4):535-44. doi: 10.1016/j.ijom.2015.11.001. Epub 2015 Nov 28.
- Alchalabi NJ, Merza AM, Issa SA. Using Carnoy's Solution in Treatment of Keratocystic Odontogenic Tumor. Ann Maxillofac Surg. 2017 Jan-Jun;7(1):51-56. doi: 10.4103/ams.ams_127_16.
- Giesenhagen B, Martin N, Donkiewicz P, Peric Kacarevic Z, Smeets R, Jung O, Schnettler R, Barbeck M. Vertical bone augmentation in a single-tooth gap with an allogenic bone ring: Clinical considerations. J Esthet Restor Dent. 2018 Nov;30(6):480-483. doi: 10.1111/jerd.12392. Epub 2018 Aug 2.
- Giesenhagen B, Martin N, Jung O, Barbeck M. Bone Augmentation and Simultaneous Implant Placement with Allogenic Bone Rings and Analysis of Its Purification Success. Materials (Basel). 2019 Apr 19;12(8):1291. doi: 10.3390/ma12081291.
- Sleman N, Khalil A. Autogenous bone ring augmentation and simultaneous implant placement in the atrophic posterior maxilla: A case report. Int J Surg Case Rep. 2025 Feb;127:110970. doi: 10.1016/j.ijscr.2025.110970. Epub 2025 Jan 27.
- Nunes MP, Nunes LFP, Filho DPN, Pinho RCM, Cimoes R. Bone Ring Technique for the Treatment of Vertical and Horizontal Bone Defects with Immediate Implants: A Report of Two Cases. Int J Periodontics Restorative Dent. 2021 May-Jun;41(3):413-421. doi: 10.11607/prd.4401.
- Nunes MP, Nunes LFP, Ribeiro JCB, Mourao Pinho RC, Cimoes R. Maxillary Sinus Elevation Using the Bone Ring Technique with Immediate Implantation: A Case Report. Int J Periodontics Restorative Dent. 2022 Jul-Aug;42(4):525-533. doi: 10.11607/prd.4746.
- Arab HR, Moeintaghavi A, Shiezadeh F, Nezhad MH. Crestal Sinus Floor Elevation with Autogenous Press-Fit Dowel Bone Harvested Using Trephine Drills: A New Method. J Long Term Eff Med Implants. 2018;28(3):209-214. doi: 10.1615/JLongTermEffMedImplants.2018017280.
- Saez-Alcaide LM, Brinkmann JC, Sanchez-Labrador L, Perez-Gonzalez F, Molinero-Mourelle P, Lopez-Quiles J. Effectiveness of the bone ring technique and simultaneous implant placement for vertical ridge augmentation: a systematic review. Int J Implant Dent. 2020 Dec 12;6(1):82. doi: 10.1186/s40729-020-00280-0.
- Flanagan D. Cylindrical Ringbone Allograft to Restore Atrophic Implant Sites: A Pilot Study. J Oral Implantol. 2016 Apr;42(2):159-63. doi: 10.1563/aaid-joi-D-15-00052. Epub 2015 Sep 8.
Study record dates
Study Major Dates
Study Start (Estimated)
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
- UDDS-2026-OralMaxillofacial-01
- DN-28102025-542 (Other Identifier: Ethics committee, Damascus University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
De-identified individual participant data that underlie the results reported in the publication, specifically: Implant Stability Quotient (ISQ) values, vertical bone gain measurements (mm), and peri-implant bone density values (Hounsfield-like units).
Beginning 6 months after publication of the primary results. Data will be available for a period of 3 years.
With Researchers who submit a methodologically sound research proposal to the principal investigator, To achieve the aims specified in the approved research proposal, particularly for individual participant data meta-analysis or secondary analyses of maxillary sinus augmentation techniques
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
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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