Maxillary Sinus Augmentation Using Different Size Bovine Bone Particles

Maxillary Sinus Augmentation Clinical Trial

Official title:

Maxillary Sinus Augmentation Using Different Size Bovine Bone Particles: a Histomorfometric Comparison

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05577520
• Other study ID #: VRDI 1801
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: August 30, 2019

Study information

• Verified date: October 2022
• Source: Universidad del Salvador, Argentina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Twenty patients were treated with SMA in two steps. They were randomly assigned to one of two groups (n=10): SPG (small particles group) and LPG (large particles group). Different size ABBM particles were implanted in their maxillary sinus, accordingly. A vertical bone core biopsy was obtained at the implant site using a punch trephine. The samples were processed for histological observation and measured histomorphometrically to determine the percentage onewly formed bone (%NB), bone substitute (%BS), bone marrow (%BM), and osseointegration (%OI). Results were statistically analyzed using Student's t test (p ≤ 0.05).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 30, 2019
• Est. primary completion date: February 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Maxillary Sinus Augmentation

Intervention

Procedure:
• Sinus floor augmentation

Locations

Country	Name	City	State
Argentina	Masters in Dental Implantology (MIO) program at the University of Salvador (USAL)-Argentine Dental Association	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Universidad del Salvador, Argentina

Country where clinical trial is conducted

Argentina, 

References & Publications (14)

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: 10.11 — View Citation

Boyne PJ, James RA. Grafting of the maxillary sinus floor with autogenous marrow and bone. J Oral Surg. 1980 Aug;38(8):613-6. — View Citation

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 t — View Citation

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. — View Citation

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: hi — View Citation

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. Review. — View Citation

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. Odontoestoma

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 — View Citation

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.2 — View Citation

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. Review. — View Citation

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

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 Pe — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of newly formed bone (NB)	histomorphometric parameter was assessed in a standardized area	10 month
Primary	Percentage of bone substitute	histomorphometric parameter was assessed in a standardized area	10 month
Primary	Percentage of bone marrow	histomorphometric parameter was assessed in a standardized area	10 month
Primary	Percentage of osseointegration	histomorphometric parameter was assessed in a standardized area, defined as the percentage of graft particle-newly formed bone integration	10 month