Surgical Complications From Local AnesthesiaPhase 4NCT01963754
Compare Subperiosteal and Loco-Regional Anesthesia in Posterior Mandible Dental Implant Installation
A Phase 4 study testing Dental Implants in Posterior Mandible, Subperiosteal 1:100.000 Articaine 4% epinephrine and Loco-regional 1:100.000 Articaine 4% epinephrine in people with Surgical Complications From Local Anesthesia and Dental Implant Failed, run by Implantology Institute at 1 site in Portugal.
Trial summary
In patients that are going to receive a dental implant in the posterior mandible (distal from canine), does the subperiosteal anesthetic technique with Articaine 1:100.000 4 % Epinephrine compared to the loco-regional one, produces the same analgesia during surgery ? Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Complications From Local Anesthesia, Dental Implant Failed, Anesthesia Complications
- What is being tested?
- Dental Implants in Posterior Mandible, Subperiosteal 1:100.000 Articaine 4% epinephrine and Loco-regional 1:100.000 Articaine 4% epinephrine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Apr 2017to Aug 2024
- Phase
- Phase 4
- 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
- Single unit implant rehabilitation
- Maxilla and mandible
- Must accept treatment plan
- Must sign informed consent
- dental extraction performed at least 3 month prior
- Must have at least 6 mm of residual bone
- Absence of oral lesions
- keratinized tissue must be present
Who cannot join
- If smoking and/or other drug addiction is present
- If local anesthetic allergy is present
- Patient subjected to chemical or radiotherapy
- if Hepatic disease is present
- If immunodepression is present
- If Pregnancy is present
- If Diabetes is present
- If Heart disease is present
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compare Articaine 1:100.000, 4% Epinephrine, Subperiosteal With Loco-regional Anesthesia for Placing Dental Implants in Posterior Mandible - Double-Blinded Randomized Clinical Trial
In patients that are going to receive a dental implant in the posterior mandible (distal from canine), does the subperiosteal anesthetic technique with Articaine 1:100.000 4 % Epinephrine compared to the loco-regional one, produces the same analgesia during surgery ?
Read the detailed description
Inter/Intra observer agreement will be made for administration of local subperiosteal, loco-regional anesthesia, operatory evaluation of pain and radiologic examination.
One group will receive articaine 1:100.000, 4% epinephrine subperiosteal and the other 1:100.000 4% epinephrine loco-regional for dental implant installation in posterior mandible.
The evaluation parameters will focus on intraoperatory pain, Intraoperatory anesthetic complications, anesthetic efficiency, correlation between distance from implant to inferior alveolar nerve, intraoperatory pain, post-operatory at 3 and 10 days and correlate changes, and survival rate of dental implants during and post osseointegration period.
- Conditions
- Surgical Complications From Local Anesthesia, Dental Implant Failed, Anesthesia Complications, Anesthesia Morbidity
- Being tested
- Dental Implants in Posterior Mandible, Subperiosteal 1:100.000 Articaine 4% epinephrine, Loco-regional 1:100.000 Articaine 4% epinephrine
- Keywords
- Articaine 1:100.000, Dental Implants, Posterior mandible, Loco-regional Anesthesia, Subperiosteal Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Implants in Posterior MandibleDevice
Also called Dental Fixtures
Place dental implants in posterior mandible, distal from canine, according to manufacturer recommendations
Subperiosteal 1:100.000 Articaine 4% epinephrineDrug
Also called Local Anesthesia
Administration of subperiosteal anesthesia for implant placement
Loco-regional 1:100.000 Articaine 4% epinephrineDrug
Also called Local Anesthesia
Administer loco-regional anesthesia for implant placement in posterior mandible
| Study group | Role | What they receive |
|---|---|---|
| Subepriosteal Articaine | Experimental | Administer Subperiosteal 1:100.000 Articaine 4% epinephrine, buccal and lingually, for Dental Implants in Posterior mandible Receives: Device: Dental Implants in Posterior Mandible; Drug: Subperiosteal 1:100.000 Articaine 4% epinephrine |
| Loco-regional Articaine | Active comparator | Administer Loco-regional 1:100.000 articaine 4% epinephrine, for Dental Implants in Posterior Mandible Receives: Device: Dental Implants in Posterior Mandible; Drug: Loco-regional 1:100.000 Articaine 4% epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthesia efficiency
Evaluate subperiosteal vs loco-regional anesthesia for implant installation in posterior mandible.
It will be measured by the amount (mean) of anesthesia pre and intraoperatory
Measured: During Surgery for Dental Implant installation
Secondary outcomes (5)
Intraoperatory Pain
It will be measured with a direct measure composed by pre and post operatory questionnaires with Visual Analog Scales (VAS) to patient and by two indirect measures, one to the clinician that performed the surgery and one by an external clinic psychologist, both by means of VAS score
Measured: During Surgery for Implant Installation in posterior mandible
Intraoperatory Anesthesia Complications
measure the amount of adverse effects of both types of procedure (subperiosteal vs loco-regional)
Measured: During Surgery for implant installation in posterior mandible
Post-Operatory Outcome Changes
measure post-operatory magnitude changes in both groups (subperiosteal vs loco-regional anesthesia) from baseline to 10 Days. It will be measured in VAS the amount of pain experienced by the patient.
Measured: Baseline (T0) 3 Days (T1) 10 Days (T2)
Time of Surgery
Measure the amount of time needed to perform dental implant installation in posterior mandible in both groups (subperiosteal Vs loco-regional)
Measured: During Surgical Procedure
Distance To Inferior Alveolar Nerve (IAN)
measure in a panoramic (orthopantomography) the distance from the implant apex to the most coronal part of the IAN and correlate to the anesthesia efficacy and operatory pain
Measured: Post operative Panoramic radiograph
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study start1 Apr 2017
- Primary completionAug 2023 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Complications From Local AnesthesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Implantology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Chen, Implantology Institute
- Investigators
- Andre Chen, Msc, Principal investigator, Implantology InstituteJoão Caramês, Phd, Study director, Implantology InstituteHelena Francisco, Msc, Study chair, Implantology InstituteElena Cervino, Msc, Study chair, Implantology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963754
- Sponsor's protocol ID
- II-03
- Status last verified
- Apr 2020
- First submitted
- 12 Oct 2013
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare Articaine 1:100.000, 4% Epinephrine, Subperiosteal With Loco-regional Anesthesia for Placing Dental Implants in Posterior Mandible - Double-Blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01963754
- Acronym / sponsor ID
- II-03
- Conditions
- Surgical Complications From Local Anesthesia, Dental Implant Failed, Anesthesia Complications, Anesthesia Morbidity
- Keywords
- Articaine 1:100.000, Dental Implants, Posterior mandible, Loco-regional Anesthesia, Subperiosteal Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Implantology InstituteUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 16 Oct 2013 (estimated)
- 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.
In patients that are going to receive a dental implant in the posterior mandible (distal from canine), does the subperiosteal anesthetic technique with Articaine 1:100.000 4 % Epinephrine compared to the loco-regional one, produces the same analgesia during surgery ?
Detailed description
Inter/Intra observer agreement will be made for administration of local subperiosteal, loco-regional anesthesia, operatory evaluation of pain and radiologic examination.
One group will receive articaine 1:100.000, 4% epinephrine subperiosteal and the other 1:100.000 4% epinephrine loco-regional for dental implant installation in posterior mandible.
The evaluation parameters will focus on intraoperatory pain, Intraoperatory anesthetic complications, anesthetic efficiency, correlation between distance from implant to inferior alveolar nerve, intraoperatory pain, post-operatory at 3 and 10 days and correlate changes, and survival rate of dental implants during and post osseointegration period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subepriosteal Articaine | Experimental | Device: Dental Implants in Posterior Mandible, Drug: Subperiosteal 1:100.000 Articaine 4% epinephrineAdminister Subperiosteal 1:100.000 Articaine 4% epinephrine, buccal and lingually, for Dental Implants in Posterior mandible |
| Loco-regional Articaine | Active comparator | Device: Dental Implants in Posterior Mandible, Drug: Loco-regional 1:100.000 Articaine 4% epinephrineAdminister Loco-regional 1:100.000 articaine 4% epinephrine, for Dental Implants in Posterior Mandible |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Single unit implant rehabilitation
- Maxilla and mandible
- Must accept treatment plan
- Must sign informed consent
- dental extraction performed at least 3 month prior
Key exclusion criteria (8 listed)
- If smoking and/or other drug addiction is present
- If local anesthetic allergy is present
- Patient subjected to chemical or radiotherapy
- if Hepatic disease is present
- If immunodepression is present
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 in Posterior MandibleAlso: Dental FixturesPlace dental implants in posterior mandible, distal from canine, according to manufacturer recommendations | Device | Loco-regional Articaine, Subepriosteal Articaine |
| Subperiosteal 1:100.000 Articaine 4% epinephrineAlso: Local AnesthesiaAdministration of subperiosteal anesthesia for implant placement | Drug | Subepriosteal Articaine |
| Loco-regional 1:100.000 Articaine 4% epinephrineAlso: Local AnesthesiaAdminister loco-regional anesthesia for implant placement in posterior mandible | Drug | Loco-regional Articaine |
Primary outcome
Anesthesia efficiency
Time frame: During Surgery for Dental Implant installation
Evaluate subperiosteal vs loco-regional anesthesia for implant installation in posterior mandible. It will be measured by the amount (mean) of anesthesia pre and intraoperatory
5 secondary outcomes
Intraoperatory Pain
Time frame: During Surgery for Implant Installation in posterior mandible
Intraoperatory Anesthesia Complications
Time frame: During Surgery for implant installation in posterior mandible
Post-Operatory Outcome Changes
Time frame: Baseline (T0) 3 Days (T1) 10 Days (T2)
Time of Surgery
Time frame: During Surgical Procedure
Distance To Inferior Alveolar Nerve (IAN)
Time frame: Post operative Panoramic radiograph
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Surgical Complications From Local Anesthesia
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.
Andre Chen, Msc principal investigator
Implantology Institute
João Caramês, Phd study director
Implantology Institute
Helena Francisco, Msc study chair
Implantology Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dental Implants in Posterior Mandible, Subperiosteal 1:100.000 Articaine 4% epinephrine and Loco-regional 1:100.000 Articaine 4% epinephrine in people with Surgical Complications From Local Anesthesia and Dental Implant Failed, run by Implantology Institute at 1 site in Portugal.
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 8 inclusion and 8 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 21 Apr 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 Portugal. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Anesthesia efficiency (time frame: During Surgery for Dental Implant installation). 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 21 Apr 2020.