Transcrestal Maxillary Sinus Floor Elevation With Injectable Bone Substitute

NCT05305521 | Completed

• 1 other identifier: INJTSFE_22
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Edentulous Alveolar Ridge

Outcome Measures

Primary Outcomes (1)

• implant survival

  implant survival rate after one year of prosthetic loading

  12 months

Secondary Outcomes (3)

• vertical bone gain

  six months

• percentual graft shrinkage

  six months

• occurrence of complications

  12 months

Study Arms (1)

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; Procedure: Implant placement

Interventions

transcrestal sinus floor elevation PROCEDURE

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.

Also known as: crestal maxillary sinus lift

Injectable TSFE

Implant placement PROCEDURE

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

Also known as: implant insertion

Injectable TSFE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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%)

Sponsors & Collaborators

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

Study Sites (2)

Hesire

Cassano Allo Ionio, CS, 87011, Italy

Location

Studio B

Verona, VR, 37045, Italy

Location

Related Publications (3)

• 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.

  PMID: 32233183 RESULT

• 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.

  PMID: 32233185 RESULT

• 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.

  PMID: 35867239 DERIVED

Study Officials

• Teresa Lombardi, Dr.

  International Piezoelectric Surgery Academy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Claudio Stacchi, DDS, MSc

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: April 15, 2018
• Primary Completion: August 15, 2021
• Study Completion: December 15, 2022
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)