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Completed

NCT Number: NCT04811768

Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation

The aim of the present prospective randomized controlled study is to clinically and histologically investigate the safety and efficacy of bony wall repositioning compared to rotary window preparation with membrane coverage in maxillary sinus floor augmentation.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Semmelweis University Department of Periodontology

Budapest, 1088, Hungary

About this study

40 patients were randomly divided in two study groups after radiological and clinical evaluation. Both groups received bone grafting by a xenogeneic bone substitute (BSM, cerabone, botiss biomaterials GmbH, Zossen, Germany) using the lateral approach. In the bony wall group (BW), following piezosurgery the retrieved bony wall was repositioned. In the collagen membrane group (CM), the lateral window was created by rotary instruments, covered via a native collagen membrane (collprotect, botiss biomaterials GmbH, Zossen, Germany). After 6 months, biopsies were taken to analyze both approaches in terms of new bone formation. Duration of treatment, the number of perforations, postoperative patient discomfort were registered. Established histopathological analysis and histomorphometrical measurements to analyze the tissue reactions and the tissue distribution, i.e., the fractions of newly formed bone tissue (NB), of remaining bone substitute material (BSM) and connective tissue (CT), were conducted.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • at least one missing maxillary premolar or molar
  • at least 7 mm crestal bone width confirmed by preoperative ConeBeam Tomography (CBCT)
  • maximally 5 mm residual bone height at the sinus floor confirmed by preoperative ConeBeam Tomography (CBCT)
  • full mouth plaque and bleeding scores (FMPS and FMBS) <20%
  • satisfactory patient compliance (e.g. to participate in follow-up procedures)
  • signed informed consent.

Exclusion criteria

  • clinically relevant diseases (e.g.: diabetes, rheumatism cancer)
  • untreated periodontitis
  • systemic steroid use
  • bisphosphonate use
  • acute or chronic inflammatory processes
  • previous endoscopic sinus surgery
  • previous sinus floor elevation
  • GBR-treatment at the study site
  • GTR-treatment at the study site
  • tooth removal within 6 weeks prior to surgery

Treatment and study plan

Maxillary sinus augmentation

Procedure

The surgery was performed under local anaesthesia in both groups, lateral window preparation and window coverage was carried out based on randomization.

Other names: Sinus lift

Primary outcomes

  1. Duration of surgery

    Time frame: During smaxillary sinus augmentation

    Recorded in minutes

Secondary outcomes

  1. Duration of lateral window preparation

    Time frame: During maxillary sinus augmentation

    Recorded in minutes

  2. Duration of mucosa preparation

    Time frame: During maxillary sinus augmentation

    Recorded in minutes

  3. Visual Analog Scale (Minimum value 0, Maximum value 100, the higher the worse)

    Time frame: 12 hours postoperatively

    Measurement of patient discomfort

  4. Visual Analog Scale (Minimum value 0, Maximum value 100, the higher the worse)

    Time frame: 1 day postoperatively

    Measurement of patient discomfort

  5. Postoperative Edema Score

    Time frame: 2 days postoperatively

    Measurement of swelling

  6. Postoperative Edema Score

    Time frame: 3 days postoperatively

    Measurement of swelling

  7. Histomorphometrical analysis

    Time frame: Following reentry 6 months after maxillary sinus augmentation

    Percentage of newly formed bone, bone substitute and connective tissue

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Collaborators

  • Botiss Medical AG
  • Dicomlab Kft.
  • Excellence Program of the Ministry for Innovation and Technology in Hungary
  • Hungarian Human Resources Development Operational Program (EFOP-3.6.2-16-2017-00006)
  • Institut Straumann AG
  • NSK Europe GmbH

Registry information

Official study title

Comparative Clinical and Histological Investigation of Graft Integration Following Piezosurgically Retrieved Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation - Prospective Randomized Controlled Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 23, 2021
Registry last updated
Mar 23, 2021

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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