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Transcrestal Maxillary Sinus Floor Elevation With Injectable Bone Substitute

NCT05305521 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2023-03-29

No results posted yet for this study

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

Interventions

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.

PROCEDURE

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

Sponsors & Collaborators

  • Teresa Lombardi DDS private practice

    collaborator UNKNOWN

  • Fabio Bernardello MD, DDS private practice

    collaborator UNKNOWN

  • Luca Lamazza DDS, PhD private practice

    collaborator UNKNOWN

  • Grzegorz Zietek DDS private practice

    collaborator UNKNOWN

  • Giuseppe Troiano DDS, PhD private practice

    collaborator UNKNOWN

  • International Piezosurgery Academy

    lead OTHER

Principal Investigators

  • Teresa Lombardi, Dr. · International Piezoelectric Surgery Academy

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-15
Primary Completion
2021-08-15
Completion
2022-12-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05305521 on ClinicalTrials.gov