Transcrestal Maxillary Sinus Floor Elevation With Injectable Bone Substitute (INJTSFEXEN)

Clinical and Radiographic Outcomes Following Transcrestal Maxillary Sinus Floor Elevation With Injectable Xenogeneic Bone Substitute in Gel Form: a Prospective Multicenter Study

To investigate clinical outcomes of transcrestal maxillary sinus floor elevation performed with an injectable xenograft in gel form, analyzing variables possibly influencing the results. Patients needing unilateral sinus floor elevation (residual crestal height <5 mm) for the placement of a single implant were enrolled. Xenograft in gel form was injected through a crestal antrostomy in order to elevate sinus membrane and fill the sub-antral space. Simultaneous implant placement was performed when adequate primary stability was achievable. Graft height was measured immediately after surgery (T0) and after six months of healing (T1). Univariate and multivariate regression models were built to assess associations between clinical variables with implant survival and graft height at T1.

Study Overview

• Status: Completed
• Conditions: Edentulous Alveolar Ridge
• Intervention / Treatment: Procedure: transcrestal sinus floor elevation; Procedure: Implant placement

Detailed Description

Purpose: To investigate clinical outcomes of transcrestal maxillary sinus floor elevation performed with an injectable xenograft in gel form, analyzing variables possibly influencing the results. Methods: Patients needing unilateral sinus floor elevation (residual crestal height <5 mm) for the placement of a single implant were enrolled. Xenograft in gel form was injected through a crestal antrostomy in order to elevate sinus membrane and fill the sub-antral space. Simultaneous implant placement was performed when adequate primary stability was achievable. Graft height was measured immediately after surgery (T0) and after six months of healing (T1). Univariate and multivariate regression models were built to assess associations between clinical variables with implant survival and graft height at T1.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Italy
  • CS
    • Cassano allo Ionio, CS, Italy, 87011
      • Hesire
  • VR
    • Verona, VR, Italy, 37045
      • Studio B

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Any partially edentulous patient needing unilateral sinus floor elevation for the placement of one dental implant supporting a single crown was eligible for entering this study

Description

Inclusion Criteria:

• residual bone crest height <5 mm and width ≥6 mm in the planned implant site;
• healed bone crest (at least 6 months elapsed from tooth loss/extraction);
• age >18 years;
• written informed consent given

Exclusion Criteria:

absolute medical contraindications to implant surgery;

• uncontrolled diabetes (HBA1c > 7.5%);
• treated or under treatment with antiresorptives;
• irradiated in the head and neck area in the last five years;
• pregnant or breastfeeding;
• substance abusers;
• psychiatric problems or unrealistic expectations;
• patient not fully able to comply with the study protocol.
• large sinus cavity (distance >12 mm between buccal and palatal walls at 10-mm level, comprising the residual alveolar crest);
• maxillary sinus conditions contraindicating sinus floor elevation;
• poor oral hygiene and motivation (Full Mouth Plaque Score >20% and or Full Mouth Bleeding Score >10%)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Injectable TSFE; partially edentulous patients needing unilateral sinus floor elevation (residual crestal height <5 mm) for the placement of a single implant

Procedure: transcrestal sinus floor elevation; Under local anesthesia (articaine 4% with epinephrine 1:100.000), a minimally invasive full-thickness flap was elevated to expose the alveolar crest. Clinicians were left free to choose their preferred transcrestal antrostomy technique. After checking sinus membrane integrity with visual inspection and Valsalva maneuver, pre-heated (40°C) xenogeneic porcine bone substitute in gel form (Gel 40, Tecnoss, Giaveno, Italy) was injected through the crestal antrostomy in order to elevate the membrane and fill the sub-antral space. Duration of graft injection (in seconds) was recorded using a digital chronometer. Periapical intraoperative radiographs were taken to confirm membrane elevation of at least 10 mm.; Other Names: crestal maxillary sinus lift; Procedure: Implant placement; Simultaneous implant placement was performed when it was possible to achieve adequate primary stability in the residual crestal bone, otherwise crestal antrostomy was sealed by collagen sponges (Hemocollagene, Septodont, Saint-Maur-des-Fossés, France) and implant insertion was postponed. Flaps were sutured with Sentineri technique and single stitches using synthetic monofilament; Other Names: implant insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
implant survival	implant survival rate after one year of prosthetic loading	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vertical bone gain	vertical bone gain (measured in mm on x-ray) six months after sinus augmentation	six months
percentual graft shrinkage	% graft shrinkage during 6-month healing period	six months
occurrence of complications	occurrence of any complication or adverse event	12 months

Collaborators and Investigators

• Sponsor: International Piezosurgery Academy
• Collaborators: Teresa Lombardi DDS private practice; Fabio Bernardello MD, DDS private practice; Luca Lamazza DDS, PhD private practice; Grzegorz Zietek DDS private practice; Giuseppe Troiano DDS, PhD private practice

Publications and helpful links

General Publications

• 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.
• 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.
• Lombardi T, Lamazza L, Bernardello F, Zietek G, Stacchi C, Troiano G. Clinical and radiographic outcomes following transcrestal maxillary sinus floor elevation with injectable xenogenous bone substitute in gel form: a prospective multicenter study. Int J Implant Dent. 2022 Jul 22;8(1):32. doi: 10.1186/s40729-022-00431-5.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Actual): August 15, 2021
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: INJTSFE_22

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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