NCT07635472

Brief Summary

This study aims to evaluate graft volumetric changes and stability up to 12 years after lateral sinus floor elevation with deproteinized bovine bone mineral (DBBM) as a filling material.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

10 months

First QC Date

May 24, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

Bone loss, deproteinized bovine bone mineral, computer-assisted image processing, dental implant, sinus floor augmentation, sinus pneumatization.

Outcome Measures

Primary Outcomes (1)

  • bovine bone mineral graft dimensional changes

    To evaluate radiologically using CBCT deproteinized bovine bone mineral graft dimensional changes in region of lateral sinus lift.

    12 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent lateral external sinus lift at the Faculty of dentistry at Saint Joseph University of Beirut

You may qualify if:

  • Patients who underwent lateral sinus floor elevation with natural bovine bone as filling material after 2011 at the Faculty of Dentistry, Saint Joseph University of Beirut.
  • At least 18 years old at baseline
  • Systemically healthy
  • Patients who sign a new informed consent.
  • Smokers (≥ 10 cigarettes/ day) and non-smokers (\< 10 cigarettes/ day)

You may not qualify if:

  • Patients who did not take a CBCT within 1 year after the initial surgery.
  • Presence of inflammatory lesions at the surgical site (eg, sinusitis as assessed by CBCT).
  • History of radiation therapy in the head/neck region.
  • Use of bisphosphonates.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Joseph University - Faculty of Dental Medicine

Beirut, Lebanon

Location

Related Publications (1)

  • 1. Couso-Queiruga E, Stuhr S, Tattan M, Chambrone L, Avila-Ortiz G. Post-extraction dimensional changes: A systematic review and meta-analysis. 2. Pjetursson BE, Heimisdottir K. Dental implants - are they better than natural teeth? Eur J Oral Sci. 2018 Oct;126(S1):81-7. 3. Menassa G, Kassir AR, Landi L, Naaman NBA, Chakar C. Implant placement with sinus floor elevation via the lateral approach using only absorbable collagen sponge: 12-month post-loading radiographical outcomes and implant survival rate. Oral Maxillofac Surg. 2021 Jun;25(2):231-6. 4. Danesh-Sani SA, Engebretson SP, Janal MN. Histomorphometric results of different grafting materials and effect of healing time on bone maturation after sinus floor augmentation: a systematic review and meta-analysis. J Periodontal Res. 2017 Jun;52(3):301-12. 5. Tatum H. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29. 6. Wiltfang J, Schultze-Mosgau S, Nkenke E, Thorwarth M, Neukam FW, Schlegel KA. Onlay augmentation versus sinuslift procedure in the treatment of the severely resorbed maxilla: a 5-year comparative longitudinal study. Int J Oral Maxillofac Surg. 2005 Dec;34(8):885-9. 7. Binger T, Hell B. Resorption of microsurgically vascularized bone grafts after augmentation of the mandible. J Cranio-Maxillo-fac Surg Off Publ Eur Assoc Cranio-Maxillo-fac Surg. 1999 Apr;27(2):82-5. 8. Jensen OT, Shulman LB, Block MS, Iacono VJ. Report of the Sinus Consensus Conference of 1996. Int J Oral Maxillofac Implants. 1998;13 Suppl:11-45. 9. Stern A, Green J. Sinus Lift Procedures: An Overview of Current Techniques. Dent Clin North Am. 2012 Jan;56(1):219-33. 10. Zijderveld SA, Schulten EAJM, Aartman IHA, ten Bruggenkate CM. Long-term changes in graft height after maxillary sinus floor elevation with different grafting materials: radiographic evaluation with a minimum follow-up of 4.5 years. Clin Oral Implants Res. 2009 Jul;20(7):691-700. 11. Schmitt C, Karasholi T, Lutz R, Wiltfang J

    BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2026

First Posted

June 9, 2026

Study Start

June 1, 2025

Primary Completion

April 6, 2026

Study Completion

May 20, 2026

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations