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

Completed

• Conditions: Atrophy of Edentulous Maxillary Alveolar Ridge
• Interventions: Procedure: transcrestal sinus floor elevation

• Registration Number: NCT03209284
• Lead Sponsor: International Piezosurgery Academy

Brief Summary

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.

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 Timeline

• Study Start: 2014-07-15
• Primary Completion: 2015-09-15
• Study Completion: 2017-02-15
• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-05
• Study First Posted: 2017-07-06
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
wide sinuses	transcrestal sinus floor elevation	transcrestal sinus floor elevation in wide sinuses
narrow sinuses	transcrestal sinus floor elevation	transcrestal sinus floor elevation in narrow sinuses

Primary Outcome Measures

Name	Time	Method
newly formed bone	6 months after surgery	assessment of newly formed bone via histomorphometric analysis

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Piezosurgery Academy; 🇮🇹 Parma, Italy