Maxillary Sinus Augmentation Using Different Size Bovine Bone Particles

NCT05577520 | Completed

• 1 other identifier: VRDI 1801
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The decrease in maxillary alveolar ridge bone volume and sinus pneumatization are a challenge to implant-assisted prosthetic rehabilitation. Guided bone regeneration using bone substitutes is an adequate alternative for maxillary sinus augmentation. Objective: To histologically and histomorphometrically compare bone repair response to 250 to 1000 µm and 1000 to 2000 µm anorganic bovine bone mineral (ABBM) particles as bone substitute in maxillary sinus augmentation (MSA).

Conditions

Maxillary Sinus Augmentation

Keywords

Sinus floor augmentation; Xenograft; Anorganic; Bovine bone; Histomorphometry

Outcome Measures

Primary Outcomes (4)

• Percentage of newly formed bone (NB)

  histomorphometric parameter was assessed in a standardized area

  10 month

• Percentage of bone substitute

  histomorphometric parameter was assessed in a standardized area

  10 month

• Percentage of bone marrow

  histomorphometric parameter was assessed in a standardized area

  10 month

• Percentage of osseointegration

  histomorphometric parameter was assessed in a standardized area, defined as the percentage of graft particle-newly formed bone integration

  10 month

Study Arms (2)

Small particle group (SPG)

EXPERIMENTAL

SPG (n=10): MSA using 250 to 1000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute.

Procedure: Sinus floor augmentation

Large particles group (LPG)

EXPERIMENTAL

LPG (n=10): MSA using 1000 to 2000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute.

Procedure: Sinus floor augmentation

Interventions

Sinus floor augmentation PROCEDURE

Also known as: Sinus floor lift, Sinus floor elevation

Large particles group (LPG); Small particle group (SPG)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients over the age of 21 years
• Patients missing teeth in the maxillary sinus region (uni- or bilaterally) with a residual subantral bone height ≤ 4 mm and an alveolar ridge width ≥ 6mm.
• Patients who had not undergone tooth extraction within 6 months prior to enrollment.

You may not qualify if:

• Patients with diabetes, blood discrasias, a history of head and neck chemotherapy/radiation therapy, acute sinusitis or a history of allergic sinusitis, chronic polypoid sinusitis, or sinus tumors, or a history of Caldwell-Luc surgery
• Women who were pregnant or of childbearing age
• Alcoholics and drug abusers
• Patients requiring MS treatment showing anatomical features of the MS that contraindicated the surgical treatment
• Patients who refused to sign the informed consent form
• Patients with a history of chronic periodontitis were treated and then enrolled in the study. Patients who developed post-operative maxillary sinus infection or showed allergic reactions attributable to the grafting material were eliminated from the study.

Sponsors & Collaborators

• Universidad del Salvador, Argentina: lead

Study Sites (1)

Masters in Dental Implantology (MIO) program at the University of Salvador (USAL)-Argentine Dental Association

Buenos Aires, 1125, Argentina

Location

Related Publications (14)

• Del Fabbro M, Testori T, Francetti L, Weinstein R. Systematic review of survival rates for implants placed in the grafted maxillary sinus. Int J Periodontics Restorative Dent. 2004 Dec;24(6):565-77.

  PMID: 15626319 BACKGROUND

• Smiler DG, Johnson PW, Lozada JL, Misch C, Rosenlicht JL, Tatum OH Jr, Wagner JR. Sinus lift grafts and endosseous implants. Treatment of the atrophic posterior maxilla. Dent Clin North Am. 1992 Jan;36(1):151-86; discussion 187-8.

  PMID: 1737600 RESULT

• Wallace SS, Froum SJ. Effect of maxillary sinus augmentation on the survival of endosseous dental implants. A systematic review. Ann Periodontol. 2003 Dec;8(1):328-43. doi: 10.1902/annals.2003.8.1.328.

  PMID: 14971260 RESULT

• Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2008.01272.x.

  PMID: 18724852 RESULT

• Cricchio G, Sennerby L, Lundgren S. Sinus bone formation and implant survival after sinus membrane elevation and implant placement: a 1- to 6-year follow-up study. Clin Oral Implants Res. 2011 Oct;22(10):1200-1212. doi: 10.1111/j.1600-0501.2010.02096.x.

  PMID: 21906186 RESULT

• Bornstein MM, Chappuis V, von Arx T, Buser D. Performance of dental implants after staged sinus floor elevation procedures: 5-year results of a prospective study in partially edentulous patients. Clin Oral Implants Res. 2008 Oct;19(10):1034-43. doi: 10.1111/j.1600-0501.2008.01573.x.

  PMID: 18828820 RESULT

• 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.

  PMID: 6993637 RESULT

• Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29.

  PMID: 3516738 RESULT

• Pejrone G, Lorenzetti M, Mozzati M, Valente G, Schierano GM. Sinus floor augmentation with autogenous iliac bone block grafts: a histological and histomorphometrical report on the two-step surgical technique. Int J Oral Maxillofac Surg. 2002 Aug;31(4):383-8. doi: 10.1054/ijom.2002.0286.

  PMID: 12361071 RESULT

• van den Bergh JP, ten Bruggenkate CM, Krekeler G, Tuinzing DB. Sinusfloor elevation and grafting with autogenous iliac crest bone. Clin Oral Implants Res. 1998 Dec;9(6):429-35. doi: 10.1034/j.1600-0501.1996.090608.x.

  PMID: 11429944 RESULT

• Chackartchi T, Iezzi G, Goldstein M, Klinger A, Soskolne A, Piattelli A, Shapira L. Sinus floor augmentation using large (1-2 mm) or small (0.25-1 mm) bovine bone mineral particles: a prospective, intra-individual controlled clinical, micro-computerized tomography and histomorphometric study. Clin Oral Implants Res. 2011 May;22(5):473-80. doi: 10.1111/j.1600-0501.2010.02032.x. Epub 2010 Nov 19.

  PMID: 21087317 RESULT

• Pebé PJ, Ramos A, Beovide AV, Borgia G, Ravecca T. Ensayo clínico aleatorizado de elevación sinusal por abordaje lateral con hueso mineral bovino desproteinizado (hmbd) comparando dos tamaños de partículas: resultados clínicos e histológicos. Odontoestomatología. 2017;19:57-67.

  RESULT

• de Molon RS, Magalhaes-Tunes FS, Semedo CV, Furlan RG, de Souza LGL, de Souza Faloni AP, Marcantonio E Jr, Faeda RS. A randomized clinical trial evaluating maxillary sinus augmentation with different particle sizes of demineralized bovine bone mineral: histological and immunohistochemical analysis. Int J Oral Maxillofac Surg. 2019 Jun;48(6):810-823. doi: 10.1016/j.ijom.2018.09.003. Epub 2018 Nov 13.

  PMID: 30442550 RESULT

• Testori T, Wallace SS, Trisi P, Capelli M, Zuffetti F, Del Fabbro M. Effect of xenograft (ABBM) particle size on vital bone formation following maxillary sinus augmentation: a multicenter, randomized, controlled, clinical histomorphometric trial. Int J Periodontics Restorative Dent. 2013 Jul-Aug;33(4):467-75. doi: 10.11607/prd.1423.

  PMID: 23820706 RESULT

MeSH Terms

Interventions

Sinus Floor Augmentation

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Bone Transplantation; Orthopedic Procedures; Dentistry

Study Officials

• jorge aguilar, Chair Prof.

  Salvador University /Argentine Dental Association (USAL/AOA)

  PRINCIPAL INVESTIGATOR

• Sandra Renou, Assoc. Prof.

  Buenos Aires University (Argentine)

  STUDY DIRECTOR

• Alicia Labandeira, Chair Prof.

  Salvador University /Argentine Dental Association (USAL/AOA)

  PRINCIPAL INVESTIGATOR

• Maria Piloni, Assoc. Prof.

  Buenos Aires University (Argentine)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Professor, Oral Implantology Program

Model Details: Small particle group (SPG n=10): MSA using 250 to 1000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute. Large particles group (LPG n=10): MSA using 1000 to 2000 µm size ABBM particles (Osteodens®, Pharmatrix, Argentina) as bone substitute.

Study Record Dates

• First Submitted: October 9, 2022
• First Posted: October 13, 2022
• Study Start: March 1, 2016
• Primary Completion: February 25, 2018
• Study Completion: August 30, 2019
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)