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

NCT03209284 | Completed DMC

• 1 other identifier: SLSS_IPA
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrophy of Edentulous Maxillary Alveolar Ridge

Keywords

maxillary atrophy; transcrestal sinus floor elevation

Outcome Measures

Primary Outcomes (1)

• newly formed bone

  assessment of newly formed bone via histomorphometric analysis

  6 months after surgery

Secondary Outcomes (2)

• implant success

  1 years after implant insertion

• exposed walls

  10 day after surgery

Study Arms (2)

narrow sinuses

transcrestal sinus floor elevation in narrow sinuses

Procedure: transcrestal sinus floor elevation

wide sinuses

transcrestal sinus floor elevation in wide sinuses

Procedure: transcrestal sinus floor elevation

Interventions

transcrestal sinus floor elevation PROCEDURE

augmentation procedure with xenograft

Also known as: implant insertion

narrow sinuses; wide sinuses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Piezosurgery Academy: lead
• University of Triste: collaborator

Study Sites (1)

Piezosurgery Academy

Parma, 43100, Italy

Location

Related Publications (4)

• 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.

  PMID: 21320169 BACKGROUND

• 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.

  PMID: 20467595 BACKGROUND

• 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.

  PMID: 20450402 BACKGROUND

• 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.

  PMID: 28125520 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

bone biopsies were retrieved at the time of implant placement (after 6 months of regenerative procedure) and obtained through implant site preparation with trephine bur

MeSH Terms

Conditions

Atrophic Maxilla

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Maxillary Diseases; Jaw Diseases; Stomatognathic Diseases

Study Officials

• Claudio Stacchi, Dr.

  Piezosurgery Academy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, MSc

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: July 6, 2017
• Study Start: July 15, 2014
• Primary Completion: September 15, 2015
• Study Completion: February 15, 2017
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)