Maxillary sinus augmentation using different osseodensification protocols: a retrospective study with 3-year follow-up

ISRCTN ISRCTN17397796
DOI https://doi.org/10.1186/ISRCTN17397796
Submission date
24/09/2025
Registration date
06/10/2025
Last edited
06/10/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
The rehabilitation of atrophic jaws may require sinus floor elevation procedures before or simultaneously with implant placement. Several surgical procedures have been documented for maxillary sinus elevation to overcome this bone resorption, and more recently, conservative and minimally invasive protocols using the osseodensification (OD) technique have been described. This study aims to determine the relationship between Insertion torque (IT) and resonance frequency analysis (RFA) on the day of implant placement. And how the ISQ varied over 36 months of follow-up.

Who can participate?
Patients at least 18 years old with healed edentulous sites in the posterior maxilla with residual bone height between 2 and 8 mm to facilitate the placement of implants requiring sinus grafting procedures

What does the study involve?
The study involves the use of a novel osseous technique in the rehabilitation of atrophic maxillae.

What are the possible benefits and risks of participating?
The use of osseodensification technique differs from other maxillary sinus elevation techniques, which use subtractive instrumentation method to perform the implant bed to the desired diameter, increasing the risk of perforation of the maxillary sinus membrane.

Where is the study run from?
Cooperativa de Ensino Superior Politécnico e Universitário (Portugal)

When is the study starting and how long is it expected to run for?
February 2019 to February 2022

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Prof. Marco Câmara, marco.camara@iucs.cespu.pt

Contact information

Prof Rosana Costa
Public, Scientific

Rua Central de Gandra
Gandra
4585-116
Portugal

ORCiD logoORCID ID 0000-0003-2462-4734
Phone +351 (0)914240555
Email rosana.costa@iucs.cespu.pt
Prof Marco Camara
Principal Investigator

Rua Central de Gandra
Gandra
4585-116
Portugal

ORCiD logoORCID ID 0000-0002-9551-5407
Phone +351 (0)914112775
Email marco.camara@iucs.cespu.pt

Study information

Study designRetrospective observational study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleSinus floor elevation using osseodensification protocols I, II and III: a retrospective study with 36 months follow-up
Study objectivesTo determine the relationship between insertion torque (IT) and resonance frequency analysis (RFA) on the day of implant placement, and how the implant stability quotient (ISQ) varied over 36 months of follow-up.
Ethics approval(s)

Approved 05/02/2019, Ethics Committee of the University Institute of Health Sciences (Rua Central de Gandra, Gandra, 4585-116, Portugal; +351 (0)224 157 100; sec.ce@cespu.pt), ref: 02/CE-IUCS/2019

Health condition(s) or problem(s) studiedDental implant stability
InterventionThe participants provided their informed consent after being thoroughly enlightened about the goal and methods of the study both orally and in writing.

A meticulous clinical examination, an assessment of oral hygiene, and a detailed analysis of the patients’ medical and dental histories comprised the initial evaluation of each patient.
Intervention typeProcedure/Surgery
Primary outcome measureInsertion torque (IT) measured using a manual torque wrench (Straumann®, Basel, Switzerland) and resonance frequency analysis (RFA) on the day of implant placement
Secondary outcome measuresThe implant stability quotient (ISQ) value was recorded as the average of buccal, lingual, mesial, and distal measurements using Osstell® IDX (Osstell, W&H, Gothenburg, Sweden) immediately after implant placement (T1); 1 year after implant placement (T2); 2 years of follow-up (T3); 3 years of follow-up (T4)
Overall study start date05/02/2019
Completion date15/02/2022

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit70 Years
SexBoth
Target number of participants190
Total final enrolment105
Key inclusion criteria1. At least 18 years old
2. Healed edentulous sites in the posterior maxilla with residual bone height between 2 and 8 mm to facilitate the placement of implants requiring sinus grafting procedures after prior analysis with Cone Beam computer Tomography (CBCT, New Tom® Go 3D, CEFLA S.C., Imola (BO) Italy)
Key exclusion criteria1. Irradiated patients
2. Impaired immune systems
3. Smoking, drug abuse or alcoholism
4. Diabetes
5. Heart disease
6. Bleeding disorders
7. Sinus pathology
8. Previous bone augmentation
9. Past or current usage of steroids or bisphosphonates
Date of first enrolment06/02/2019
Date of final enrolment06/02/2022

Locations

Countries of recruitment

  • Portugal

Study participating centre

University Institute of Health Sciences - IUCS
Rua Central de Gandra
Gandra
4585-116
Portugal

Sponsor information

Funders

Funder type

Not defined

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/01/2026
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in non-publicly available repository
Publication and dissemination plan
IPD sharing planThe datasets generated during the current study are stored in a non-publicly available repository (https://repositorio.cespu.pt/)

Editorial Notes

29/09/2025: Study's existence confirmed by the Ethics Committee of the University Institute of Health Sciences.