Bone Formation Maxillary Sinus Width

NCT04830670 | Completed

• 1 other identifier: WIDE&NARROW
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 3

Brief Summary

According to previous scientific evidence lining on biological concept of bone regeneration into the maxillary sinus, an observational study was set up to record possible (hypothesized) difference in bone formation between different width of the maxillary sinus itself. Therefore, a multicenter study was set up that foresaw a surgical intervention of sinus lift with lateral approach, the 6 months healing phase, the implant insertion in two sites with the implant site preparation made by a trephine bur to retrieve a bone specimen for histomorphometric examination without any additive invasively for the patient.

Conditions

Alveolar Bone Resorption

Keywords

Sinus lift;; sinus elevation;; sinus width;; bone graft; histomorphometry; alveolar bone atrophy

Outcome Measures

Primary Outcomes (1)

• quantity (%) of newly formed bone

  quantity (%) of newly formed bone (NFB) in histomorphometric analysis

  6 months

Secondary Outcomes (2)

• quantity (%) of graft

  6 months

• quantity of complications

  through study completion, an average of 1 year

Study Arms (2)

Large sinus

same patient, sinus width \> 12mm measured at 10mm from the alveolar crest at the planned implant site

Procedure: sinus floor elevation with lateral approach

narrow sinus

same patient, sinus width \< 12mm measured at 10mm from the alveolar crest at the planned implant site

Procedure: sinus floor elevation with lateral approach

Interventions

sinus floor elevation with lateral approach PROCEDURE

sinus floor elevation with lateral approach. 6 months healing phase. implant site preparation with trephine bur and bone specimen retrieval.

Large sinus; narrow sinus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient with Kennedy class II partial edentulism (Kennedy 1928) requiring unilateral sinus floor elevation for the placement of two not adjacent dental implants supporting a fixed partial prosthesis was eligible for entering this study

You may qualify if:

• height of the residual bone crest \<5 mm in both sites where implant placement was planned;
• age \>18 years;
• written informed consent given.

You may not qualify if:

• general contraindications to implant surgery
• smokers
• uncontrolled diabetes (HBA1c \> 7.5%)
• treated or under treatment with intravenous antiresorptive drugs
• allergy to bovine collagen
• immunosuppressed
• irradiated in the head and neck area
• pregnant or breastfeeding
• substance abusers
• psychiatric problems or unrealistic expectations
• patient not fully able to comply with the study protocol.
• maxillary sinus conditions contraindicating sinus floor elevation
• poor oral hygiene and motivation (FMPS \>25 and or FMBS\>20)
• Schneiderian membrane perforation during surgery

Sponsors & Collaborators

• International Piezosurgery Academy: lead

Study Sites (3)

Hesire

Cassano Allo Ionio, CS, 87011, Italy

Location

Studio

Gorizia, GO, 34170, Italy

Location

Studio B

Verona, VR, 37045, Italy

Location

Related Publications (4)

• Stacchi C, Spinato S, Lombardi T, Bernardello F, Bertoldi C, Zaffe D, Nevins M. Minimally Invasive Management of Implant-Supported Rehabilitation in the Posterior Maxilla, Part I. Sinus Floor Elevation: Biologic Principles and Materials. Int J Periodontics Restorative Dent. 2020 May/Jun;40(3):e85-e93. doi: 10.11607/prd.4497.

  PMID: 32233183 RESULT

• Stacchi C, Spinato S, Lombardi T, Bernardello F, Bertoldi C, Zaffe D, Nevins M. Minimally Invasive Management of Implant-Supported Rehabilitation in the Posterior Maxilla, Part II. Surgical Techniques and Decision Tree. Int J Periodontics Restorative Dent. 2020 May/Jun;40(3):e95-e102. doi: 10.11607/prd.4498.

  PMID: 32233185 RESULT

• Stacchi C, Vercellotti T, Toschetti A, Speroni S, Salgarello S, Di Lenarda R. Intraoperative complications during sinus floor elevation using two different ultrasonic approaches: a two-center, randomized, controlled clinical trial. Clin Implant Dent Relat Res. 2015 Jan;17 Suppl 1:e117-25. doi: 10.1111/cid.12136. Epub 2013 Aug 22.

  PMID: 23968289 RESULT

• 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 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

alveolar bone specimen containing native bone, regenerated bone (with residual graft particles); the specimens were retrieved with a trephine bur that prepared the same time the implant site.

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Claudio Stacchi, Dr.

  Piezoelectricsurgery Academy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 5, 2021
• Study Start: March 15, 2017
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2021
• Last Updated: April 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)