Clinical trial NCT05305521: Transcrestal Maxillary Sinus Floor Elevation With Injectable Bone Substitute
Official title: Clinical and Radiographic Outcomes Following Transcrestal Maxillary Sinus Floor Elevation With Injectable Xenogeneic Bone Substitute in Gel Form: a Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Edentulous Alveolar Ridge
Lead sponsor: International Piezosurgery Academy
Sponsor class: OTHER
Collaborators: name: Teresa Lombardi DDS private practice
name: Fabio Bernardello MD, DDS private practice
name: Luca Lamazza DDS, PhD private practice
name: Grzegorz Zietek DDS private practice
name: Giuseppe Troiano DDS, PhD private practice
First posted: 2022-03-31
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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%)

Primary outcomes:
measure: implant survival
timeFrame: 12 months
Secondary outcomes:
measure: vertical bone gain
timeFrame: six months
measure: percentual graft shrinkage
timeFrame: six months
measure: occurrence of complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Cassano allo Ionio
country: Italy
facility: Hesire
state: CS
city: Verona
country: Italy
facility: Studio B
state: VR
Study officials:
affiliation: International Piezoelectric Surgery Academy
name: Teresa Lombardi, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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 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.
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. 2020 May/Jun;40(3):e95-e102. doi: 10.11607/prd.4498.
citation: 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.