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

International Piezosurgery Academy

Status: Completed

Conditions: Edentulous Alveolar Ridge

Treatments: Procedure: Implant placement; Procedure: transcrestal sinus floor elevation

Study type: Observational

Funder types: Other

Identifiers

NCT05305521

INJTSFE_22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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%)

Trial design

70 participants in 1 patient group

Injectable TSFE

Description:

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

Treatment:

Procedure: transcrestal sinus floor elevation

Procedure: Implant placement