Implant StabilityNCT04345133
Effect of Undersized Drilling Upon the Immediate Implants
A study testing Dental Implants Insertion Drilling Sequence in people with Implant Stability, run by University of Carabobo.
Trial summary
OBJECTIVE: evaluate the effect of undersized drilling upon the primary and secondary stability of immediate implants placed in the anterior sector maxilla. PATIENTS AND METHODS Study design A randomized comparative clinical trial was carried out. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant Stability
- What is being tested?
- Dental Implants Insertion Drilling Sequence
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2017to 17 Mar 2018
- 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
- indication of one or more immediate implants in the anterior maxilla; No history of ischemic heart disease, No History of uncontrolled diabetes, No coagulation disorders, No head or neck radiotherapy
Who cannot join
- Periodontal Disease. History of EV or Oral Bisphosphonate
About this study
Official title: Effect of Undersized Drilling Upon the Primary and Secondary Stability of Immediate Conical Implants in the Esthetic Maxillary Sector
OBJECTIVE:
evaluate the effect of undersized drilling upon the primary and secondary stability of immediate implants placed in the anterior sector maxilla.
Read more
PATIENTS AND METHODS Study design A randomized comparative clinical trial was carried out. Thirty conical MIS C1 grade 23 titanium alloy (Ti 6Al 4V Eli) implants with a rough surface subjected to dual acid etching and sandblasting, measuring 3.75 mm in maximum diameter and 13 mm in length (MIS® Implants Technologies, Ltd. Bar Levi, Israel), were placed immediately after removal a anterior maxillary tooth in a series of patients treated in the clinic of the Master of Dentistry and Dental Implantology (Santa María University, Dental School, Caracas, Venezuela). The study was approved by the local Ethics Committee.
Patient selection To enrolled in the study, patients had to comply the inclusion/exclusion criteria established to the study: over 18 years of age with indication of one or more immediate implants in the anterior maxilla; no history of ischemic heart disease, uncontrolled diabetes, coagulation disorders, head or neck radiotherapy, intravenous bisphosphonates or uncontrolled periodontal disease. Based on a CTCB evaluation, the teeth involved should have presence of bone ≥ 5 mm from the tooth apex to the lower cortical layer of the nasal fossa / maxillary sinus and no vertical defects greater than 4 mm at the buccal or palatine alveolar crest. Also, patients must have capacity to understand the study protocol and fill consent form to participation in the study.
Study procedure Two operators calibrated for immediate implant placement performed minimally traumatic tooth extraction following local infiltrating anesthesia with 4% articaine and 1:100,000 epinephrine (Artheek® 4%, New Stetic S.A.; Antioquia, Colombia). After evaluating the integrity of the bone walls, drilling sequence was established on a randomized basis.
Conventional drilling (CD) sequence:
- Marking drill ∅1.9 mm at 1500 rpm
- Pilot drill ∅ 2.4 mm and 13 mm in length at 800 rpm.
- Twist drill ∅3 mm at 400 rpm.
Undersized drilling (UD) sequence:
Marking drill ∅1.9 mm at 1500 rpm Pilot drill ∅ 2.4 mm and 13 mm in length at 400 rpm. Implant insertion A surgical motor (MCU MIS, model M0132, W\&H, Burmoos, Austria) with a 20:1 reducing implant handpiece was used to insert the implants at 20 rpm and applying a torque of 10 Ncm. Following placement of the implant in the bed, manual insertion was continued to reach the final implant position, established as 4 mm from the gingival margin.
Study variables Two torque meters (MIS® Implants LTD, models MT-RI040 and MT-RT070, Bar Levi, Israel) were used to insert and sequentially measure the maximum IT reached on positioning the implant in the socket. A Smart-peg Nro 49 model 100480 was fitted to the connection of each implant and an Osstell ISQ® (SN 4669 Osstell AB, Goteborg, Sweden) was used to perform RFA analysis and obtain corresponding ISQ value at insertion time (RFA1). A 4 mm height healing screw was used to seal the implant, and then additional RFA measurements was made at 6 week (RFA2) and 12 week (RFA3) post-implantation
- Conditions
- Implant Stability
- Being tested
- Dental Implants Insertion Drilling Sequence
- Keywords
- Primary Stability, Secondary Stability, Undersized Drilling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Implants Insertion Drilling SequenceDevice
Drilling sequence protocol to insert immediate Dental Implants at the Maxilla.
| Study group | Role | What they receive |
|---|---|---|
| Undersized Drilling Group | Active comparator | Exposed patients to the reduction of the final drill dimensions at the insertion implants protocol sequence Receives: Device: Dental Implants Insertion Drilling Sequence |
| Conventional Drilling Group | Other | Group with the conventional protocol recommended by the manufacturer Receives: Device: Dental Implants Insertion Drilling Sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insertion Torque
Maximum torque in N.cm obtained during insertion of the implant
Measured: at baseline, through study completion in average 1 year
RFA Implant Stability
Implant Stability measure by Radio-Frequency Analysis.
Measured: at baseline, through study completion in average 1 year
Secondary outcomes (2)
RFA2 Implant Stability
Implant Stability measure by Radio-Frequency Analysis 6 weeks later
Measured: 6 weeks after baseline, trough study completion in average 1 year
RFA3 Implant Stability
Implant Stability measure by Radio-Frequency Analysis 12 weeks later
Measured: 12 weeks after baseline, trough study completion in average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start9 Jan 2017
- Primary completion17 Dec 2017
- Study completion17 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implant StabilityStudies 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
- Single group
- Model description
- Comparative
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Carabobo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Sierra-Rebolledo, University of Carabobo
- Investigators
- Alejandro Sierra-Rebolledo, DDS, Principal investigator, University of Carabobo, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345133
- Sponsor's protocol ID
- UCarabobo
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study protocol is included in the medical records of the postgraduate degree and there are identity protection policies.
Publications
Sierra-Rebolledo A, Allais-Leon M, Maurette-O'Brien P, Gay-Escoda C. Primary Apical Stability of Tapered Implants Through Reduction of Final Drilling Dimensions in Different Bone Density Models: A Biomechanical Study. Implant Dent. 2016 Dec;25(6):775-782. doi: 10.1097/ID.0000000000000479.
PubMed 27540846
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Undersized Drilling Upon the Primary and Secondary Stability of Immediate Conical Implants in the Esthetic Maxillary Sector
- ClinicalTrials.gov ID
- NCT04345133
- Acronym / sponsor ID
- UCarabobo
- Conditions
- Implant Stability
- Keywords
- Primary Stability, Secondary Stability, Undersized Drilling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CaraboboUniversity, hospital or other
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 17 Dec 2017 (actual)
- Study completion
- 17 Mar 2018 (actual)
- First posted
- 14 Apr 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.
OBJECTIVE:
evaluate the effect of undersized drilling upon the primary and secondary stability of immediate implants placed in the anterior sector maxilla.
PATIENTS AND METHODS Study design A randomized comparative clinical trial was carried out. Thirty conical MIS C1 grade 23 titanium alloy (Ti 6Al 4V Eli) implants with a rough surface subjected to dual acid etching and sandblasting, measuring 3.75 mm in maximum diameter and 13 mm in length (MIS® Implants Technologies, Ltd. Bar Levi, Israel), were placed immediately after removal a anterior maxillary tooth in a series of patients treated in the clinic of the Master of Dentistry and Dental Implantology (Santa María University, Dental School, Caracas, Venezuela). The study was approved by the local Ethics Committee.
Patient selection To enrolled in the study, patients had to comply the inclusion/exclusion criteria established to the study: over 18 years of age with indication of one or more immediate implants in the anterior maxilla; no history of ischemic heart disease, uncontrolled diabetes, coagulation disorders, head or neck radiotherapy, intravenous bisphosphonates or uncontrolled periodontal disease. Based on a CTCB evaluation, the teeth involved should have presence of bone ≥ 5 mm from the tooth apex to the lower cortical layer of the nasal fossa / maxillary sinus and no vertical defects greater than 4 mm at the buccal or palatine alveolar crest. Also, patients must have capacity to understand the study protocol and fill consent form to participation in the study.
Study procedure Two operators calibrated for immediate implant placement performed minimally traumatic tooth extraction following local infiltrating anesthesia with 4% articaine and 1:100,000 epinephrine (Artheek® 4%, New Stetic S.A.; Antioquia, Colombia). After evaluating the integrity of the bone walls, drilling sequence was established on a randomized basis.
Conventional drilling (CD) sequence:
- Marking drill ∅1.9 mm at 1500 rpm
- Pilot drill ∅ 2.4 mm and 13 mm in length at 800 rpm.
- Twist drill ∅3 mm at 400 rpm.
Undersized drilling (UD) sequence:
Marking drill ∅1.9 mm at 1500 rpm Pilot drill ∅ 2.4 mm and 13 mm in length at 400 rpm. Implant insertion A surgical motor (MCU MIS, model M0132, W\&H, Burmoos, Austria) with a 20:1 reducing implant handpiece was used to insert the implants at 20 rpm and applying a torque of 10 Ncm. Following placement of the implant in the bed, manual insertion was continued to reach the final implant position, established as 4 mm from the gingival margin.
Study variables Two torque meters (MIS® Implants LTD, models MT-RI040 and MT-RT070, Bar Levi, Israel) were used to insert and sequentially measure the maximum IT reached on positioning the implant in the socket. A Smart-peg Nro 49 model 100480 was fitted to the connection of each implant and an Osstell ISQ® (SN 4669 Osstell AB, Goteborg, Sweden) was used to perform RFA analysis and obtain corresponding ISQ value at insertion time (RFA1). A 4 mm height healing screw was used to seal the implant, and then additional RFA measurements was made at 6 week (RFA2) and 12 week (RFA3) post-implantation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Comparative
| Arm | Type | Receives |
|---|---|---|
| Undersized Drilling Group | Active comparator | Device: Dental Implants Insertion Drilling SequenceExposed patients to the reduction of the final drill dimensions at the insertion implants protocol sequence |
| Conventional Drilling Group | Other | Device: Dental Implants Insertion Drilling SequenceGroup with the conventional protocol recommended by the manufacturer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- indication of one or more immediate implants in the anterior maxilla; No history of ischemic heart disease, No History of uncontrolled diabetes, No coagulation disorders, No head or neck radiotherapy
Key exclusion criteria (1 listed)
- Periodontal Disease. History of EV or Oral Bisphosphonate
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 |
|---|---|---|
| Dental Implants Insertion Drilling SequenceDrilling sequence protocol to insert immediate Dental Implants at the Maxilla. | Device | Conventional Drilling Group, Undersized Drilling Group |
Primary outcome
Insertion Torque
Time frame: at baseline, through study completion in average 1 year
Maximum torque in N.cm obtained during insertion of the implant
RFA Implant Stability
Time frame: at baseline, through study completion in average 1 year
Implant Stability measure by Radio-Frequency Analysis.
2 secondary outcomes
RFA2 Implant Stability
Time frame: 6 weeks after baseline, trough study completion in average 1 year
RFA3 Implant Stability
Time frame: 12 weeks after baseline, trough study completion in average 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Background: PubMed 27540846Sierra-Rebolledo A, Allais-Leon M, Maurette-O'Brien P, Gay-Escoda C. Primary Apical Stability of Tapered Implants Through Reduction of Final Drilling Dimensions in Different Bone Density Models: A Biomechanical Study. Implant Dent. 2016 Dec;25(6):775-782. doi: 10.1097/ID.0000000000000479.
- Individual participant dataSharing planned: No. The study protocol is included in the medical records of the postgraduate degree and there are identity protection policies.
Related trials for Implant Stability
RecruitingPhase 2/3
Lactoferrin Nanohydrogel for Soft And Hard Tissue Healing and Implant Stability in Immediate Implant Placement
Dental Implant, Wound Healing
Recruiting
Digital Eye®-Assisted Bone Density Classification and Primary Dental Implant Stability.
Bone Mineral Density, Primary Implant Stability
RecruitingObservational study
Movement of Dental Implants During Osseointegration
Dental Implants, Osseointegration
Active, not recruitingObservational study
Long-Term Stability of Soft and Hard Tissues After Guided Bone Regeneration in the Maxillary Anterior Region
Alveolar Bone Deficiency
Recruiting
Melatonin Effect on Immediate Dental Implants in the Posterior Mandible
Dental Implant, Immediate Dental Implant Placement
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.
Alejandro Sierra-Rebolledo, DDS principal investigator
University of Carabobo, Faculty of Dentistry
Questions about this trial
What is this clinical trial studying?
A study testing Dental Implants Insertion Drilling Sequence in people with Implant Stability, run by University of Carabobo.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insertion Torque (time frame: at baseline, through study completion in average 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04345133, which also lists 1 linked publication.
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 14 Apr 2020.