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Using Chin Bone Rings for Sinus Lifting and Dental Implants in One Surgery (BRT-SINUS)

28. august 2026 opdateret af: Damascus University

Evaluation of Effectiveness of Bone Ring Technique in One Stage Surgery of External Maxillary Sinus Lifting With Implantation: A Prospective Case Series

This study evaluates the Bone Ring Technique, a single stage procedure that combines external sinus floor elevation and dental implant placement using an autogenous bone ring harvested from the chin. Ten patients with residual alveolar bone height ≤4 mm in the posterior maxilla will be enrolled. Implant stability (ISQ), vertical bone gain, peri implant bone density, and implant survival will be assessed over 6 months. The aim is to reduce treatment time and surgical interventions compared to traditional two stage approaches.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Syrien
    • Governorate
      • Damascus, Governorate, Syrien, 4671
        • Rekruttering
        • Oral and Maxillofacial Surgery Hospital, Faculty of Dentistry, Damascus University, Mezzeh Highway, Damascus, Syria

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Procedure: Bone Ring Technique (BRT)
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Implant Stability Quotient (ISQ).
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Vertical Bone Gain (mm)
Tidsramme: 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
at preoperative, 1 week post_surgery , 6 months post_surgery
Peri implant Bone Density (gray values)
Tidsramme: at preoperative, 1 week post_surgery , 6 months post_surgery
regions of interest: coronal, middle, apical thirds
at preoperative, 1 week post_surgery , 6 months post_surgery
Implant Survival & Success
Tidsramme: 6 months post_surgery
Survival = implant in situ. Success = absence of mobility, persistent pain, peri implant radiolucency, suppuration; and crestal bone loss <1.5 mm on CBCT.
6 months post_surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Damascus University

Efterforskere

  • Studieleder: Khaldoun Darwich, DDS MSc PhD, Damascus University Syria

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. maj 2026

Primær færdiggørelse (Anslået)

21. februar 2027

Studieafslutning (Anslået)

21. marts 2027

Datoer for studieregistrering

Først indsendt

26. maj 2026

Først indsendt, der opfyldte QC-kriterier

26. maj 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UDDS-2026-OralMaxillofacial-01
  • DN-28102025-542 (Anden identifikator: Ethics committee, Damascus University)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

Starting 6 months after publication of primary results for a period of 3 years.

IPD-delingsadgangskriterier

Requests for data access should be directed to the principal investigator (Adel Alassaf) via adel96.alassaf@damascusuniversity.edu.sy. Access will be granted to qualified researchers whose proposed use of the data has been approved by an independent review committee. Requesters will need to sign a Data Use Agreement (DUA) and ensure IRB approval or exemption for their proposed research.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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