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

ISRCTN	ISRCTN17397796
DOI	https://doi.org/10.1186/ISRCTN17397796
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Cooperativa de Ensino Superior Politécnico e Universitário
Funder	Investigator initiated and funded

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

Study information

Primary study design	Observational
Study design	Retrospective observational study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Sinus floor elevation using osseodensification protocols I, II and III: a retrospective study with 36 months follow-up
Study objectives	To 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) studied	Dental implant stability
Intervention	The 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 type	Procedure/Surgery
Primary outcome measure(s)	Insertion torque (IT) measured using a manual torque wrench (Straumann®, Basel, Switzerland) and resonance frequency analysis (RFA) on the day of implant placement
Key secondary outcome measure(s)	The 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)
Completion date	15/02/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	All
Target sample size at registration	190
Total final enrolment	105
Key inclusion criteria	1. 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 criteria	1. 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 enrolment	06/02/2019
Date of final enrolment	06/02/2022

Locations

Countries of recruitment

Portugal

Study participating centre

University Institute of Health Sciences - IUCS

Rua Central de Gandra
Gandra
4585-116
Portugal

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in non-publicly available repository
IPD sharing plan	The datasets generated during the current study are stored in a non-publicly available repository (https://repositorio.cespu.pt/)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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