NCT04811768

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

1.2 years

First QC Date

March 9, 2021

Last Update Submit

March 19, 2021

Conditions

Maxillary Sinus Augmentation

Keywords

maxillary sinusxenogeneic graftcollagen membranelateral bony wall repositioningpiezoelectric surgery

Outcome Measures

Primary Outcomes (1)

  • Duration of surgery

    Recorded in minutes

    During smaxillary sinus augmentation

Secondary Outcomes (7)

  • Duration of lateral window preparation

    During maxillary sinus augmentation

  • Duration of mucosa preparation

    During maxillary sinus augmentation

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

    12 hours postoperatively

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

    1 day postoperatively

  • Postoperative Edema Score

    2 days postoperatively

  • +2 more secondary outcomes

Study Arms (2)

Bony wall group

EXPERIMENTAL

In the bony wall group, following piezosurgery the retrieved bony wall was repositioned.

Procedure: Maxillary sinus augmentation

Collagen membrane group

EXPERIMENTAL

In the collagen membrane group, the lateral window was created by rotary instruments, covered via a native collagen membrane (collprotect, botiss biomaterials GmbH, Zossen, Germany).

Procedure: Maxillary sinus augmentation

Interventions

Maxillary sinus augmentationPROCEDURE

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

Also known as: Sinus lift
Bony wall groupCollagen membrane group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semmelweis University Department of Periodontology

Budapest, 1088, Hungary

Location

Related Publications (1)

  • Molnar B, Jung AK, Papp Z, Martin A, Orban K, Prohl A, Jung O, Barbeck M, Windisch P. Comparative analysis of lateral maxillary sinus augmentation with a xenogeneic bone substitute material in combination with piezosurgical preparation and bony wall repositioning or rotary instrumentation and membrane coverage: a prospective randomized clinical and histological study. Clin Oral Investig. 2022 Aug;26(8):5261-5272. doi: 10.1007/s00784-022-04494-x. Epub 2022 May 20.

    PMID: 35593928DERIVED

MeSH Terms

Interventions

Sinus Floor Augmentation

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeBone TransplantationOrthopedic ProceduresDentistry

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Histology analysis was performed blinded, randomization sequence was revealed after histomorphometry
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 40 patients underwent sinus floor augmentation - 20 patients treated by bony wall repositioning, 20 patients treated by collagen membrane coverage
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Balint Molnar DMD, PhD, associate professor

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 23, 2021

Study Start

March 1, 2017

Primary Completion

May 30, 2018

Study Completion

May 30, 2018

Last Updated

March 23, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)