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- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Adel Alassaf, DDS
- Numéro de téléphone: +963 949038706
- E-mail: sx19adel@gmail.com
Lieux d'étude
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Governorate
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Damascus, Governorate, Syrie, 4671
- Recrutement
- Oral and Maxillofacial Surgery Hospital, Faculty of Dentistry, Damascus University, Mezzeh Highway, Damascus, Syria
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Implant Stability Quotient (ISQ).
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Vertical Bone Gain (mm)
Délai: 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)
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Khaldoun Darwich, DDS MSc PhD, Damascus University Syria
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies osseuses
- Maladies musculo-squelettiques
- Maladies stomatognathiques
- Maladies de la mâchoire
- Anomalies de la mâchoire
- Anomalies maxillo-faciales
- Anomalies craniofaciales
- Anomalies musculosquelettiques
- Maladies mandibulaires
- Anomalies du système stomatognathique
- Anomalies congénitales
- Maladies et anomalies congénitales, héréditaires et néonatales
- Rétrognathie
- La résorption osseuse
Autres numéros d'identification d'étude
- UDDS-2026-OralMaxillofacial-01
- DN-28102025-542 (Autre identifiant: Ethics committee, Damascus University)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
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