Influence of Anatomy of Maxillary Sinus on New Bone Formation After Transcrestal Augmentation Procedures (SLSS)

Influence of the Anatomical Variability of the Maxillary Sinus on New Bone Formation After Transcrestal Augmentation Procedures

The aim of this study is to analyze neoformed bone after maxillary sinus lifting with transcrestal approach, in atrophic crests (≤5 mm residual bone height). Clinical and laboratory data will be related to maxillo breast anatomy.

Study Overview

• Status: Completed
• Conditions: Atrophy of Edentulous Maxillary Alveolar Ridge
• Intervention / Treatment: Procedure: transcrestal sinus floor elevation

Detailed Description

Bone resorption and sinus pneumatization, following tooth extraction, are common occurrences in the posterior maxilla. They may cause both a quantitative reduction and qualitative deterioration of bone, resulting in an inadequate bone volume for a standard implant placement. Sinus floor elevation with lateral approach had been described 35 years ago and widely studied afterwards, demonstrating an high predictability in regenerating bone, to allow for reliable implant supported rehabilitations. Maxillary sinus floor elevation with transcrestal approach represents a validated and effective alternative option to vertically enhance the available bone through an access created in the edentulous bone crest. Regardless of graft type, it is not yet well defined how three-dimensional anatomical sinus cavity characteristics may influence healing and mineralization process. An adequate Schneiderian membrane elevation in order to expose sinus floor, buccal and medial walls, seems to represent a crucial factor in influencing new bone formation, as the greatest part of the osteoprogenitor cells derives from these anatomical structures. It is not documented yet the efficacy of the different trnanscrestal sinus floor elevation approaches in exposing the internal bony walls of the sinus. Moreover, on the basis of the fact that only few articles correlated the size of the maxillary sinus with histologic outcome by lateral window and one retrospective radiographic study reported results in relation to the three-dimensional conformation of the sinus using a trans-crestal approach, the investigators conjecture that sinus bucco-palatal diameter could influence the newly-formed bone quality after a crestal sinus lift procedure. For example, the healing in a narrow maxillary sinus could result in a faster new bone formation, when compared to a larger and wider sinus. The aim of this study is to analyze neoformed bone after maxillary sinus lifting with transcrestal approach, in atrophic crests (≤5 mm residual bone height). Clinical and laboratory data will be related to maxillo breast anatomy. The present study has been designed as a multicenter prospective clinical trial. Five clinical centers will treat patients with two-stage transcrestal sinus floor elevation using a calibrated drills technique and a xenogeneic biomaterial. Implants will be inserted 6 months after sinus augmentation and bone-core biopsies will be harvested during the implant site preparation. Histological analyses will be performed in order to assess the quality of the newly-formed tissue and cone beam computed tomography scan examination will be used to evaluate graft resorption over time. For each inserted implant, collection of experimental parameters will be required up to 1 year after its placement.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Italy
  • Parma, Italy, 43100
    • Piezosurgery Academy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population was composed of all patients presenting for evaluation and management of any partial edentulism requiring unilateral maxillary sinus elevation. To be included in the study sample, patients had to present a residual crestal height on the sinus floor less than 5 mm, to be 18 years or older, and able to understand and sign a written informed consent form.

Description

Inclusion Criteria:

Local inclusion criteria will be the following:

• indications for a transcrestal sinus floor augmentation to allow for a single implant placement, based on accurate diagnosis and treatment planning;
• presence of a residual bone crest with a height ≤3 mm on the maxillary sinus in the site where implant placement is programmed;
• the bone crest must be healed (at least three months elapsed after tooth loss);
• age of the patient >18 years;
• patient willing and fully capable to comply with the study protocol;
• written informed consent given.

General exclusion criteria are:

• acute myocardial infarction within the past 2 months;
• uncontrolled coagulation disorders;
• uncontrolled diabetes (HBA1c > 7.5%);
• radiotherapy to the head/neck district within the past 24 months;
• immunocompromised patient (HIV infection or chemotherapy within the past 5 years);
• present or past treatment with intravenous bisphosphonates;
• psychological or psychiatric problems;
• alcohol or drugs abuse.

Exclusion Criteria:

• Local exclusion criterion is the presence of uncontrolled or untreated periodontal disease.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
narrow sinuses; transcrestal sinus floor elevation in narrow sinuses	Procedure: transcrestal sinus floor elevation; augmentation procedure with xenograft; Other Names: implant insertion
wide sinuses; transcrestal sinus floor elevation in wide sinuses	Procedure: transcrestal sinus floor elevation; augmentation procedure with xenograft; Other Names: implant insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
newly formed bone	assessment of newly formed bone via histomorphometric analysis	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
implant success	short term implant success rate via clinical and radiographic data	1 years after implant insertion
exposed walls	number of sinuses exposed walls after augmentation procedure via cone beam computed tomography	10 day after surgery

Collaborators and Investigators

• Sponsor: International Piezosurgery Academy
• Collaborators: University of Triste

Publications and helpful links

General Publications

• Farina R, Pramstraller M, Franceschetti G, Pramstraller C, Trombelli L. Alveolar ridge dimensions in maxillary posterior sextants: a retrospective comparative study of dentate and edentulous sites using computerized tomography data. Clin Oral Implants Res. 2011 Oct;22(10):1138-1144. doi: 10.1111/j.1600-0501.2010.02087.x. Epub 2011 Feb 15.
• Esposito M, Grusovin MG, Rees J, Karasoulos D, Felice P, Alissa R, Worthington H, Coulthard P. Effectiveness of sinus lift procedures for dental implant rehabilitation: a Cochrane systematic review. Eur J Oral Implantol. 2010 Spring;3(1):7-26.
• Avila G, Wang HL, Galindo-Moreno P, Misch CE, Bagramian RA, Rudek I, Benavides E, Moreno-Riestra I, Braun T, Neiva R. The influence of the bucco-palatal distance on sinus augmentation outcomes. J Periodontol. 2010 Jul;81(7):1041-50. doi: 10.1902/jop.2010.090686.
• Lombardi T, Stacchi C, Berton F, Traini T, Torelli L, Di Lenarda R. Influence of Maxillary Sinus Width on New Bone Formation After Transcrestal Sinus Floor Elevation: A Proof-of-Concept Prospective Cohort Study. Implant Dent. 2017 Apr;26(2):209-216. doi: 10.1097/ID.0000000000000554.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 15, 2014
• Primary Completion (ACTUAL): September 15, 2015
• Study Completion (ACTUAL): February 15, 2017

Study Registration Dates

• First Submitted: July 4, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (ACTUAL): July 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: maxillary atrophy; transcrestal sinus floor elevation
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: SLSS_IPA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No