Transcrestal Maxillary Sinus Floor Elevation With Injectable Bone Substitute

Completed

• Conditions: Edentulous Alveolar Ridge
• Interventions: Procedure: transcrestal sinus floor elevation; Procedure: Implant placement

• Registration Number: NCT05305521
• Lead Sponsor: International Piezosurgery Academy

Brief 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.

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 Timeline

• Study Start: 2018-04-15
• Primary Completion: 2021-08-15
• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Study Completion: 2022-12-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Injectable TSFE	Implant placement	partially edentulous patients needing unilateral sinus floor elevation (residual crestal height \<5 mm) for the placement of a single implant
Injectable TSFE	transcrestal sinus floor elevation	partially edentulous patients needing unilateral sinus floor elevation (residual crestal height \<5 mm) for the placement of a single implant

Primary Outcome Measures

Name	Time	Method
implant survival	12 months	implant survival rate after one year of prosthetic loading

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Hesire; 🇮🇹 Cassano allo Ionio, CS, Italy

Studio B; 🇮🇹 Verona, VR, Italy