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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Adel Alassaf, DDS
- 電話番号：+963 949038706
- メール：sx19adel@gmail.com
研究場所
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Governorate
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Damascus、Governorate、シリア、4671
- 募集
- Oral and Maxillofacial Surgery Hospital, Faculty of Dentistry, Damascus University, Mezzeh Highway, Damascus, Syria
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Need for dental implant in posterior maxilla (premolar/molar).
- Residual alveolar bone height ≤4 mm on preoperative CBCT.
- Age ≥18 years.
- Controlled systemic health.
- Able to comply with procedures and follow up.
- Good oral hygiene.
- Signed written informed consent.
Exclusion Criteria:
- Uncontrolled systemic disease.
- Head/neck radiotherapy.
- Bisphosphonate therapy >3 years.
- Autoimmune disease affecting healing.
- Pregnancy/lactation.
- Active maxillary sinus pathology (sinusitis, cysts, polyps, tumours).
- Heavy smoking (>10 cigarettes/day).
- Severe bruxism.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Implant Stability Quotient (ISQ).
時間枠：Immediately after implant placement (baseline) and 6 months post_surgery (before prosthetic loading).
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Measured by resonance frequency analysis with MEGA ISQ II (MegaGen, Korea), Four readings per implant (mesial, distal, buccal, lingual); mean value reported
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Immediately after implant placement (baseline) and 6 months post_surgery (before prosthetic loading).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Vertical Bone Gain (mm)
時間枠：at preoperative, 1 week post_surgery , 6 months post_surgery
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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)
時間枠：at preoperative, 1 week post_surgery , 6 months post_surgery
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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
時間枠：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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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Khaldoun Darwich, DDS MSc PhD、Damascus University Syria
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- UDDS-2026-OralMaxillofacial-01
- DN-28102025-542 (その他の識別子：Ethics committee, Damascus University)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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