Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001311741
Ethics application status
Approved
Date submitted
21/04/2022
Date registered
11/10/2022
Date last updated
11/10/2022
Date data sharing statement initially provided
11/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the primary stability in patients with different techniques for placement of subantral implants: conventional drilling, underpreparation and use of motorized expanders.
Scientific title
Evaluation of primary stability with different surgical techniques: conventional drilling, underpreparation and use of motorized expanders for subantral implant placement in adult patients with low-quality bone.
Secondary ID [1] 306675 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Single edentulism or partial edentulism in posterior maxilla 325712 0
Condition category
Condition code
Oral and Gastrointestinal 323056 323056 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 323057 323057 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Placement of subantral implants using different techniques:
- Under preparation: under-drilling or preparation with drills with a diameter smaller than the diameter of the implant.
- Use of motorized bone expanders: the expanders are inserted into the bone with motor-driven rotation, which decreases surgical trauma and provides more control over the expansion site. The thread pattern compacts the bone laterally as the instrument is advanced toward the bone crest.
- Under preparation: once only 1-2 hours session.
- Use of motorized bone expanders: once only 1-2 hours session.
At 12 weeks in the second surgical phase, the ISQ will be measured in all patients.
This intervention will be carried out by professors of Oral Surgery in the operating room of official master of oral surgery and implantology at the University of Granada.
Intervention code [1] 323172 0
Treatment: Surgery
Comparator / control treatment
Control group: conventional drilling.
Drilled with all implant drills following the protocol indicated by the implant brand.
Once only 1-2 hours session.
At 12 weeks in the second surgical phase, the ISQ will be measured in all patients.
Control group
Active

Outcomes
Primary outcome [1] 330819 0
Implant stability quotient (ISQ): to measure primary stability.
Timepoint [1] 330819 0
- On the day of surgery: ISQ is measured when implants are placed.
- 12 weeks after surgery: ISQ is measured again.
The Osstell ISQ module from W&H, which is available as an accessory, enables a safe assessment of implant stability. The Implant Stability Quotient (ISQ) has been tested in numerous clinical studies.
Primary outcome [2] 330820 0
Insertion torque: it is measured with the motor that places the implant.

The Insertion torque promotes a rotation in the implant on which the force is applied, being expressed in Ncm units.
Timepoint [2] 330820 0
The insertion torque is measured on the day of surgical intervention when implants are placed.
Secondary outcome [1] 407696 0
Early failure of the implant

It is measured when the implant presents clinical and radiological symptoms
Timepoint [1] 407696 0
Insertion torque can only be measured at the time the implants have been placed.
Our secondary outcome variable insertion torque does influence early implant failure. Thus, a very low insertion torque can be associated with early implant failure.

Eligibility
Key inclusion criteria
-Patients who present single or partial edentulism at the level of the upper premolars and molars and who wish to have implants placed
-Subjects over 18 years of age
- Patients who do not abuse alcohol, drugs or chronic smokers (< 10 cigarettes a day)
- Patients with an adequate periodontal status and if they suffer from previously treated periodontal disease
- Patients with no known mental disorders, with an adequate level of education to understand the study and who sign their informed consent to participate in it.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Pregnant or lactating women
- Patients with a systemic disease or drug treatment that could affect the osseointegration process
- Patients undergoing radiotherapy
- Patients with diabetes not controlled by treatment or diet
- Patients with a serious psychiatric disease, suspected of having drug abuse, tobacco or alcoholism
- Patients with poor oral hygiene or untreated periodontal disease
- Patients who will not meet the standards of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the calculation of the sample size, a confidence level of 95% and a power of 90% were considered, so a total of 105 implants will have to be collected, which will be divided randomly by means of a table of random numbers generated by computer. in 3 treatment groups of 35 implants each:

Group I: 35 implants inserted through the underpreparation technique.
Group II: 35 implants placed using motorized expanders.
Group III: 35 implants inserted through conventional drilling.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2022
Actual
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
105
Accrual to date
Final
Recruitment outside Australia
Country [1] 24678 0
Spain
State/province [1] 24678 0
Granada

Funding & Sponsors
Funding source category [1] 311005 0
University
Name [1] 311005 0
University of Granada
Country [1] 311005 0
Spain
Primary sponsor type
University
Name
Department of Stomatology. Faculty of Dentistry, University of Granada.
Address
Cartuja University Campus s/n. Postal Code: 18011
GRANADA
Country
Spain
Secondary sponsor category [1] 312389 0
None
Name [1] 312389 0
Address [1] 312389 0
Country [1] 312389 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310556 0
HUMAN RESEARCH ETHICS COMMITTEE UNIVERSITY OF GRANADA
Ethics committee address [1] 310556 0
Ethics committee country [1] 310556 0
Spain
Date submitted for ethics approval [1] 310556 0
12/08/2021
Approval date [1] 310556 0
07/10/2021
Ethics approval number [1] 310556 0
2324/CEIH/2021.

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118070 0
Prof Mª de Nuria Romero Olid
Address 118070 0
Colegio Máximo s/n
Cartuja University Campus
CP 18011, Granada
Country 118070 0
Spain
Phone 118070 0
+34 649855096
Fax 118070 0
+34 958 24 40 85
Email 118070 0
[email protected]
Contact person for public queries
Name 118071 0
Mª de Nuria Romero Olid
Address 118071 0
Colegio Máximo s/n
Cartuja University Campus
CP 18011, Granada
Country 118071 0
Spain
Phone 118071 0
+34 649855096
Fax 118071 0
+34 958 24 40 85
Email 118071 0
[email protected]
Contact person for scientific queries
Name 118072 0
Mª de Nuria Romero Olid
Address 118072 0
Colegio Máximo s/n
Cartuja University Campus
CP 18011, Granada
Country 118072 0
Spain
Phone 118072 0
+34 649855096
Fax 118072 0
+34 958 24 40 85
Email 118072 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.