- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07550491
Influence of Residual Bone Height on Marginal Bone Loss Around Implants Following Lateral Sinus Floor Augmentation With Deproteinized Bovine Bone Mineral
Influence of Residual Bone Height on Marginal Bone Loss Around Implants Following Lateral Sinus Floor Augmentation With Deproteinized Bovine Bone Mineral: A Retrospective Study Up to 12 Years.
Data collection will be done on all patients who underwent a lateral maxillary sinus floor augmentation in the Faculty of Dental Medicine, both in the Periodontology Department and in the Oral Surgery Department.
Pre-surgical residual bone height will be measured on patients with a preoperative CBCT, and marginal bone loss will be measured in patients with a postoperative periapical radiograph that dates at least 3 years after implant placement.
In contrast to other studies who only associated between the presurgical residual bone height and implant survival / success rate, this study design takes a more in depth approach and measures the exact marginal bone loss on each implant. In addition, other factors will be taken into consideration (implant type, smoking status, diabetes status) to eliminate any confounding factors.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Beirut, Lebanon
- Saint Joseph University of Beirut
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients who underwent a lateral maxillary sinus floor augmentation using deproteinated bovine bone matrix (DBBM) at the faculty before 2022.
- Patients with pre-operative CBCT.
- Patients with no visible sinus infection in the pre-operative CBCT.
Exclusion Criteria:
- Patients who do not have a pre-operative CBCT.
- Patients who do not have a post-operative orthogonal periapical radiograph that dates at least 3 years after implant placement.
- Presence of inflammatory lesions at the surgical site (eg, sinusitis as assessed by CBCT).
- Cases with sinus perforation.
- History of radiation therapy in the head/neck region.
- Use of bisphosphonates
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Grafted Bone
residual bone height < 2mm
|
Sinus lift was performed to the patients, then after 9 months dental implants were placed.
|
|
Native Bone
residual bone height > 2mm
|
Sinus lift was performed to the patients, then after 9 months dental implants were placed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Marginal Bone Loss
Time Frame: at least 3 years after implant placement
|
mesial and distal marginal bone loss were calculated from the implant platform to the first bone to implant contact
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at least 3 years after implant placement
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29.
- Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available.
- Boyne PJ, James RA. Grafting of the maxillary sinus floor with autogenous marrow and bone. J Oral Surg. 1980 Aug;38(8):613-6. No abstract available.
- Jamcoski VH, Faot F, Marcello-Machado RM, Melo ACM, Fontao FNGK. 15-Year Retrospective Study on the Success Rate of Maxillary Sinus Augmentation and Implants: Influence of Bone Substitute Type, Presurgical Bone Height, and Membrane Perforation during Sinus Lift. Biomed Res Int. 2023 Feb 20;2023:9144661. doi: 10.1155/2023/9144661. eCollection 2023.
- Park WB, Kang KL, Han JY. Factors influencing long-term survival rates of implants placed simultaneously with lateral maxillary sinus floor augmentation: A 6- to 20-year retrospective study. Clin Oral Implants Res. 2019 Oct;30(10):977-988. doi: 10.1111/clr.13505. Epub 2019 Aug 1.
- Rios HF, Avila G, Galindo P, Bratu E, Wang HL. The influence of remaining alveolar bone upon lateral window sinus augmentation implant survival. Implant Dent. 2009 Oct;18(5):402-12. doi: 10.1097/ID.0b013e3181b4af93.
- Galindo-Moreno P, Fernandez-Jimenez A, O'Valle F, Silvestre FJ, Sanchez-Fernandez E, Monje A, Catena A. Marginal bone loss in implants placed in grafted maxillary sinus. Clin Implant Dent Relat Res. 2015 Apr;17(2):373-83. doi: 10.1111/cid.12092. Epub 2013 May 28.
- Del Fabbro M, Wallace SS, Testori T. Long-term implant survival in the grafted maxillary sinus: a systematic review. Int J Periodontics Restorative Dent. 2013 Nov-Dec;33(6):773-83. doi: 10.11607/prd.1288.
- Beretta M, Poli PP, Grossi GB, Pieroni S, Maiorana C. Long-term survival rate of implants placed in conjunction with 246 sinus floor elevation procedures: results of a 15-year retrospective study. J Dent. 2015 Jan;43(1):78-86. doi: 10.1016/j.jdent.2014.08.006. Epub 2014 Aug 20.
- Buser D, Dula K, Hess D, Hirt HP, Belser UC. Localized ridge augmentation with autografts and barrier membranes. Periodontol 2000. 1999 Feb;19:151-63. doi: 10.1111/j.1600-0757.1999.tb00153.x. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMD-SF192
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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