Transcrestal Maxillary Sinus Floor Elevation With Injectable Bone Substitute

Edentulous Alveolar Ridge Clinical Trial

— INJTSFEXEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05305521
• Other study ID #: INJTSFE_22
• Status: Completed
• Start date: April 15, 2018
• Est. completion date: December 15, 2022

Study information

• Verified date: March 2023
• Source: International Piezosurgery Academy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 15, 2022
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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%)

Related Conditions & MeSH terms

• Edentulous Alveolar Ridge
• Mouth, Edentulous

Intervention

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.
• 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

Locations

Country	Name	City	State
Italy	Hesire	Cassano allo Ionio	CS
Italy	Studio B	Verona	VR

Sponsors (6)

Lead Sponsor	Collaborator
International Piezosurgery Academy	Fabio Bernardello MD, DDS private practice, Giuseppe Troiano DDS, PhD private practice, Grzegorz Zietek DDS private practice, Luca Lamazza DDS, PhD private practice, Teresa Lombardi DDS private practice

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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 Periodontic — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	implant survival	implant survival rate after one year of prosthetic loading	12 months
Secondary	vertical bone gain	vertical bone gain (measured in mm on x-ray) six months after sinus augmentation	six months
Secondary	percentual graft shrinkage	% graft shrinkage during 6-month healing period	six months
Secondary	occurrence of complications	occurrence of any complication or adverse event	12 months