Dental ImplantsNCT04497571
Immediate Load in Dental Implants Using Conventional Drilling and Piezoelectric Osteotomy on Aesthetic Zone.
A study testing Piezoelectric osteotomy. and Conventional drilling in people with Dental Implants and Tooth Loss, run by Universidad de Granada at 1 site in Spain.
Trial summary
Compare the survival rate of the implants placed using the ultrasonic technique and placed using conventional drilling, with an immediate load on the aesthetic zone. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants, Tooth Loss
- What is being tested?
- Piezoelectric osteotomy. and Conventional drilling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2020to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Absence of teeth on the aesthetic zone, whether its an incisor, canine or premolar.
- 3 months after the dental extraction without alveolar scar tissue remains.
- Bone availability of at least 5mm of width and 13mm of length.
- At least 2 to 3 mm of soft tissue for the establishment of an adequate peri-implant biological width.
- Oclusal pattern that ensures prosthetic success.
- Implants need to have at least a 35 N and 70 ISQ index to be loaded.
- Index of plaque < 20% and/or inactive periodontal disease.
Who cannot join
- Acute myocardial infarction in the last 2 months.
- Uncontrolled coagulation disorders
- Uncontrolled diabetes (HbA1c> 7.5%).
- Radiotherapy on head/neck in the last 24 months.
- Immunocompromised patient.
- History of medication related to osteonecrosis of the jaws.
Show all 9Show fewer
- Psychiatric disorders, alcohol, drugs and large smokers (>10 cigarrillos).
- Plaque index > 20%.
- Need for simultaneous or previous peri-implant guided bone regeneration procedures.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Isabel Godoy Reina
Almería, 04001
Isabel Godoy Reina, 661070242, igodorei@gmail.com
About this study
Official title: Immediate Load in Dental Implants Using Conventional Drilling and Piezoelectric Osteotomy on Aesthetic Zone: Randomized Clinical Trials.
Compare the survival rate of the implants placed using the ultrasonic technique and placed using conventional drilling, with an immediate load on the aesthetic zone.
Read the detailed description
Main goals.
Compare the survival rate of the implants placed using the ultrasonic technique and placed using conventional drilling, with an immediate load on the aesthetic zone.
Specific goals.
- Evaluate the marginal peri-implant bone loss after the healing period through radiographs, from the day of surgery, to a month, to 3 and 6 months after and a year after the implants insertion.
- Evaluate the primary stability of each individual implant the day of their insertion to verify their load on the moment of surgery and also compare the values of each preparation techniques of implant bone preparation.
- Evaluate the secondary stability of each individual implant and compare the values of each preparation techniques.
- Evaluate the peri-implant clinic parameters within 3 and 6 months and a year after the insertion of the implants through these variables: probing depth and bleeding of probing.
- Conditions
- Dental Implants, Tooth Loss
- Being tested
- Piezoelectric osteotomy., Conventional drilling
- Keywords
- Dental implants, Piezoelectric osteotomy, Piezoelectric surgery, Immediate load
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezoelectric osteotomy.Procedure or surgery
Implants placed using the ultrasonic technique.
Conventional drillingProcedure or surgery
Implants placed using drilling technique
| Study group | Role | What they receive |
|---|---|---|
| Piezoelectric osteotomy | Experimental | Implant placement by piezoelectric osteotomy Receives: Procedure: Piezoelectric osteotomy. |
| Conventional drilling | Active comparator | Implant placement by conventional drilling Receives: Procedure: Conventional drilling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Loss
To compare MBL measured using radiographs.
Measured: 1 month
Marginal Bone Loss
To compare MBL measured using radiographs.
Measured: 3 months
Marginal Bone Loss
To compare MBL measured using radiographs.
Measured: 6 months
Marginal Bone Loss
To compare MBL measured using radiographs.
Measured: 12 months
Secondary outcomes (5)
Primary stability
Implant Stability Quotient Values (Osstell ISQ, Osstell USA) obtained from implants in study site, recording immediately.
Measured: Baseline
Secondary stability
Implant Stability Quotient Values (Osstell ISQ, Osstell USA) obtained from implants in study site, recording at 3 months.
Measured: 3 months
Probing depth
Evaluate the peri-implant clinic parameters within 3 and 6 months and a year after the insertion of the implants through these variables: probing depth and bleeding of probing.
Measured: 3,6,12 months
Bleeding of probing
Evaluate the peri-implant clinic parameters within 3 and 6 months and a year after the insertion of the implants through these variables: probing depth and bleeding of probing.
Measured: 3,6,12 months
Survival rate
To measure implant success rate.
Measured: 3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start1 Jun 2020
- Primary completionApr 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trials.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel Godoy Reina, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497571
- Sponsor's protocol ID
- IGR UGranada
- Status last verified
- Aug 2020
- First submitted
- 28 Jul 2020
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Load in Dental Implants Using Conventional Drilling and Piezoelectric Osteotomy on Aesthetic Zone: Randomized Clinical Trials.
- ClinicalTrials.gov ID
- NCT04497571
- Acronym / sponsor ID
- IGR UGranada
- Conditions
- Dental Implants, Tooth Loss
- Keywords
- Dental implants, Piezoelectric osteotomy, Piezoelectric surgery, Immediate load
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare the survival rate of the implants placed using the ultrasonic technique and placed using conventional drilling, with an immediate load on the aesthetic zone.
Detailed description
Main goals.
Compare the survival rate of the implants placed using the ultrasonic technique and placed using conventional drilling, with an immediate load on the aesthetic zone.
Specific goals.
- Evaluate the marginal peri-implant bone loss after the healing period through radiographs, from the day of surgery, to a month, to 3 and 6 months after and a year after the implants insertion.
- Evaluate the primary stability of each individual implant the day of their insertion to verify their load on the moment of surgery and also compare the values of each preparation techniques of implant bone preparation.
- Evaluate the secondary stability of each individual implant and compare the values of each preparation techniques.
- Evaluate the peri-implant clinic parameters within 3 and 6 months and a year after the insertion of the implants through these variables: probing depth and bleeding of probing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trials.
| Arm | Type | Receives |
|---|---|---|
| Piezoelectric osteotomy | Experimental | Procedure: Piezoelectric osteotomy.Implant placement by piezoelectric osteotomy |
| Conventional drilling | Active comparator | Procedure: Conventional drillingImplant placement by conventional drilling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Absence of teeth on the aesthetic zone, whether its an incisor, canine or premolar.
- 3 months after the dental extraction without alveolar scar tissue remains.
- Bone availability of at least 5mm of width and 13mm of length.
- At least 2 to 3 mm of soft tissue for the establishment of an adequate peri-implant biological width.
- Oclusal pattern that ensures prosthetic success.
Key exclusion criteria (9 listed)
- Acute myocardial infarction in the last 2 months.
- Uncontrolled coagulation disorders
- Uncontrolled diabetes (HbA1c> 7.5%).
- Radiotherapy on head/neck in the last 24 months.
- Immunocompromised patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piezoelectric osteotomy.Implants placed using the ultrasonic technique. | Procedure or surgery | Piezoelectric osteotomy |
| Conventional drillingImplants placed using drilling technique | Procedure or surgery | Conventional drilling |
Primary outcome
Marginal Bone Loss
Time frame: 1 month
To compare MBL measured using radiographs.
Marginal Bone Loss
Time frame: 3 months
To compare MBL measured using radiographs.
Marginal Bone Loss
Time frame: 6 months
To compare MBL measured using radiographs.
Marginal Bone Loss
Time frame: 12 months
To compare MBL measured using radiographs.
5 secondary outcomes
Primary stability
Time frame: Baseline
Secondary stability
Time frame: 3 months
Probing depth
Time frame: 3,6,12 months
Bleeding of probing
Time frame: 3,6,12 months
Survival rate
Time frame: 3,6,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezoelectric osteotomy. and Conventional drilling in people with Dental Implants and Tooth Loss, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal Bone Loss (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.