NCT07619846

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
May 2026Mar 2027

First Submitted

Initial submission to the registry

May 26, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

May 31, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2027

Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

9 months

First QC Date

May 26, 2026

Last Update Submit

June 3, 2026

Conditions

Keywords

Bone Ring TechniqueMaxillary Sinus Floor ElevationDental Implant

Outcome Measures

Primary Outcomes (1)

  • Implant Stability Quotient (ISQ).

    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 Outcomes (3)

  • Vertical Bone Gain (mm)

    at preoperative, 1 week post_surgery , 6 months post_surgery

  • Peri implant Bone Density (gray values)

    at preoperative, 1 week post_surgery , 6 months post_surgery

  • Implant Survival & Success

    6 months post_surgery

Study Arms (1)

Bone Ring Technique (BRT)

EXPERIMENTAL

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)

Interventions

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.

Bone Ring Technique (BRT)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oral and Maxillofacial Surgery Hospital, Faculty of Dentistry, Damascus University, Mezzeh Highway, Damascus, Syria

Damascus, Governorate, 4671, Syria

Location

Related Publications (10)

  • 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.

    PMID: 28713736BACKGROUND
  • 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.

    PMID: 30070751BACKGROUND
  • 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.

    PMID: 31010149BACKGROUND
  • 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.

    PMID: 39879710BACKGROUND
  • 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.

    PMID: 34076639BACKGROUND
  • 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.

    PMID: 35830319BACKGROUND
  • 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.

    PMID: 30806279BACKGROUND
  • 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.

    PMID: 33313968BACKGROUND
  • 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.

    PMID: 26348838BACKGROUND
  • 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.

    PMID: 26644216BACKGROUND

Study Officials

  • Khaldoun Darwich, professor of OMFS

    Damascus University Syria

    STUDY DIRECTOR

Central Study Contacts

Adel Alassaf, Resident &MSc candidate in OMF

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, single-arm case series. All eligible patients with residual alveolar bone height ≤4 mm in the posterior maxilla will receive the same intervention: one-stage external maxillary sinus lifting using the autogenous Bone Ring Technique with simultaneous dental implant placement. Participants will be followed for 6 months post-surgery. No comparator group is included.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2026

First Posted

June 2, 2026

Study Start

May 31, 2026

Primary Completion (Estimated)

February 21, 2027

Study Completion (Estimated)

March 21, 2027

Last Updated

June 4, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Starting 6 months after publication of primary results for a period of 3 years.
Access Criteria
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.

Locations