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NCT Number: NCT05305521

Transcrestal Maxillary Sinus Floor Elevation With Injectable Bone Substitute

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.

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Key information

Conditions

Edentulous Alveolar Ridge

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hesire, Cassano Allo Ionio, CS, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

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.

Other names: crestal maxillary sinus lift

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

Other names: implant insertion

Primary outcomes

  1. implant survival

    Time frame: 12 months

    implant survival rate after one year of prosthetic loading

Secondary outcomes

  1. vertical bone gain

    Time frame: six months

    vertical bone gain (measured in mm on x-ray) six months after sinus augmentation

  2. percentual graft shrinkage

    Time frame: six months

    % graft shrinkage during 6-month healing period

  3. occurrence of complications

    Time frame: 12 months

    occurrence of any complication or adverse event

Sponsors and collaborators

Lead sponsor

International Piezosurgery Academy

Other

Collaborators

  • Fabio Bernardello MD, DDS private practice
  • Giuseppe Troiano DDS, PhD private practice
  • Grzegorz Zietek DDS private practice
  • Luca Lamazza DDS, PhD private practice
  • Teresa Lombardi DDS private practice

Registry information

Official study title

Clinical and Radiographic Outcomes Following Transcrestal Maxillary Sinus Floor Elevation With Injectable Xenogeneic Bone Substitute in Gel Form: a Prospective Multicenter Study

Acronym: INJTSFEXEN

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Mar 31, 2022
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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