Periodontal DiseasesNCT01742559
The Anesthetic Effect of Anterior Middle Superior Alveolar Technique
A study testing Anterior middle superior alveolar and Supraperiosteal technique in people with Periodontal Diseases and Local Anesthesia, run by State University of Maringá at 1 site in Brazil.
Trial summary
Anesthesia of the soft and hard tissues in the maxilla may require up to five injections. Thus, the aim of the present study was to evaluate the anesthetic efficacy in buccal tissues after the use of the anterior middle superior alveolar (AMSA) and supraperiosteal techniques during subgingival scaling and root… Read more about this study
- Who is it for?
- Ages 27 to 60 years
- Conditions the study is for
- Periodontal Diseases, Local Anesthesia, Pain
- What is being tested?
- Anterior middle superior alveolar and Supraperiosteal technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2009to Jul 2011
- 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 27 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- localized or generalized periodontal disease;
- ≥ 3 teeth with probing depth ≥ 5 mm in anteroposterior teeth in each maxillary dental arch of the maxilla; a minimum of 6 natural teeth in the maxilla (incisors, canines and premolars);
- good overall systemic health and absence of allergy to any component of the anesthetic used.
Who cannot join
- Patients who had any type of systemic condition that counter indicated periodontal treatment;
- Patients who had taken, within the last 72 hours prior to procedure, any central nervous system depressant, such as alcohol, non-opioid and opioid.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Anesthetic Effect of Anterior Middle Superior Alveolar Technique (AMSA) for Non-surgical Periodontal Procedures: a Randomized Controlled Clinical Study
Anesthesia of the soft and hard tissues in the maxilla may require up to five injections. Thus, the aim of the present study was to evaluate the anesthetic efficacy in buccal tissues after the use of the anterior middle superior alveolar (AMSA) and supraperiosteal techniques during subgingival scaling and root planning (SRP).
Read the detailed description
Patients with periodontal disease often have deep pockets that require scaling and root planing (SRP) and, hence, anesthesia of the periodontal tissues to control pain may be necessary. The proper anesthesia of the mucogingival tissues in the maxilla may need up to five injections of anesthetic solution. Thus, these various injections will anesthetize the (i) posterior superior alveolar, (ii) middle superior alveolar, (iii) anterior superior alveolar, (iv) greater palatine and (v) nasopalatine nerves. Although these series of anesthetic injections are effective to anesthetize the tissues of the jaw, they can reach other unwanted structures, such as the upper lip, the nostrils and lower eyelid, causing postoperative discomfort to the patient and minimizing the patient's ability to smile and show the top line of the lip.
In order to minimize the side effects and allow a smaller number of punctures and amount of anesthetic solution used for control the pain in the maxilla, Friedman \& Hochman (1998) described the anterior middle superior alveolar anesthetic technique (AMSA), for various dental procedures in the jaw. The AMSA has the ability to not anesthetize, undesirably, other anatomical structures beyond the periodontium and teeth such as upper lip, bridge of the nose and lower eyelid. This advantage occurs due to the fact that the anesthetic solution is administrated in a small location on the palate where it is not able to reach the sensory fibers of the lips and face and, therefore, does not alter the activity of the muscles that deal with facial expressions. In addition, the administration of only 0.6 to 0.9 ml of anesthetic, is able to induce anesthesia of the pulpal and soft tissues of the palate region. This is a significantly smaller amount of anesthetic than what is usually administered for the desired analgesia for dental and periodontal structures.
The biological plausibility of the AMSA technique is due to the resilience of the tissues of the palate and the application of the anesthetic solution with controlled pressure and flow, so that it reaches the underlying bone and neurovascular anatomy. The penetration of the anesthetic in the tissues from the palate promotes the diffusion of the solution through numerous channels of nutrients and pores in the cortical bone of the palate4. With the spread of the anesthetic in the tissues, structures typically innervated by the anterior superior alveolar nerves, middle and posterior, nasopalatine and greater palatine are anesthetized.
Several reports have suggested that this technique is effective to anesthetize teeth and maxillary tissues extending from the mesial root of first molar to central incisor with a single infiltration. However, there are no controlled studies in the literature that specifically evaluate the vestibular tissue analgesia, considering patient comfort during the procedure for scaling and root planing.
Therefore, the aim of this study was to evaluate the anesthetic efficacy of AMSA technique of tissues at the buccal aspect of the ridge compared to conventional supraperiosteal techniques in the buccal area during the process of scaling and root planing of periodontal pockets in the jaw.
- Conditions
- Periodontal Diseases, Local Anesthesia, Pain
- Being tested
- Anterior middle superior alveolar, Supraperiosteal technique
- Keywords
- Treatment
- Medical subject headings
- Periodontal Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior middle superior alveolarProcedure or surgery
The AMSA technique is performed according to Friedman \& Hochman (1997). The needle is introduced with the bevel towards the palate tissue with a 45 ° angle and axially rotated (45° clockwise/45° counterclockwise) and 0.6 ml of the anesthetic was slowly infiltrated for 1 minute. In the control group a supraperiosteal infiltration (infiltrative) at the bottom of the vestibule is performed for one minute and 1.8 ml of anesthetic solution is administrated. This amount of anesthetic is divided into doses of 0.6 ml infiltrated, respectively, in the region of the incisors, canines and premolars. After the anesthetic technique, two minutes would be expected for the beginning of the periodontal procedure.
Supraperiosteal techniqueProcedure or surgery
Also called Infiltrative technique
The supraperiosteal technique is performed at the bottom of the vestibule for one minute and 1.8 ml of anesthetic solution is administrated. This amount of anesthetic is divided into doses of 0.6 ml infiltrated, respectively, in the region of the incisors, canines and premolars. After the anesthetic technique, two minutes would be expected for the beginning of the scaling and root planning procedure.
| Study group | Role | What they receive |
|---|---|---|
| Anterior middle superior alveolar | Experimental | The AMSA technique was performed in the test group according to Friedman \& Hochman (1997). The needle was introduced with the bevel towards the palate tissue with a 45 ° angle and axially rotated (45° clockwise/45° counterclockwise) and 0.6 ml of the anesthetic was slowly infiltrated for 1 minute. In the control group a supraperiosteal infiltration (infiltrative) at the bottom of the vestibule was performed for one minute and 1.8 ml of anesthetic solution was administrated. This amount of anesthetic was divided into doses of 0.6 ml infiltrated, respectively, in the region of the incisors, canines and premolars. After the anesthetic technique, two minutes were expected for the beginning of the periodontal procedure. Receives: Procedure: Anterior middle superior alveolar |
| Supraperiosteal technique | Active comparator | The supraperiosteal technique at the bottom of the vestibule was performed for one minute and 1.8 ml of anesthetic solution was administrated. This amount of anesthetic was divided into doses of 0.6 ml infiltrated, respectively, in the region of the incisors, canines and premolars. After the anesthetic technique, two minutes were expected for the beginning of the SRP procedure. Receives: Procedure: Supraperiosteal technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Severity of Pain
Just after the anesthetic injection the scaling and root planing procedure was performed. The patients were followed by thirty minutes after the beginning of the procedure and the patients expressed pain by placing a vertical line on a visual analogue metric scale (VAS: Visual Analog Scale).
Measured: 30 minutes after the antesthetic injection
Secondary outcomes (1)
Assessment of the discomfort according to gender
Just after the anesthetic injection the scaling and root planing procedure was performed. The patients were followed by thirty minutes after the beginning of the procedure and the patients expressed pain by placing a vertical line on a visual analogue metric scale (VAS: Visual Analog Scale).
Measured: 30 minutes after the antesthetic injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startJan 2009
- Primary completionAug 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of Maringá
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Barbisan de Souza, DDS, State University of Maringá
- Investigators
- Maurício Araújo, PhD, Study chair, State University of Maringá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742559
- Sponsor's protocol ID
- AMSA-0101
- Status last verified
- Dec 2012
- First submitted
- 30 Oct 2012
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Anesthetic Effect of Anterior Middle Superior Alveolar Technique (AMSA) for Non-surgical Periodontal Procedures: a Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT01742559
- Acronym / sponsor ID
- AMSA-0101
- Conditions
- Periodontal Diseases, Local Anesthesia, Pain
- Keywords
- Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- State University of MaringáUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 5 Dec 2012 (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.
Anesthesia of the soft and hard tissues in the maxilla may require up to five injections. Thus, the aim of the present study was to evaluate the anesthetic efficacy in buccal tissues after the use of the anterior middle superior alveolar (AMSA) and supraperiosteal techniques during subgingival scaling and root planning (SRP).
Detailed description
Patients with periodontal disease often have deep pockets that require scaling and root planing (SRP) and, hence, anesthesia of the periodontal tissues to control pain may be necessary. The proper anesthesia of the mucogingival tissues in the maxilla may need up to five injections of anesthetic solution. Thus, these various injections will anesthetize the (i) posterior superior alveolar, (ii) middle superior alveolar, (iii) anterior superior alveolar, (iv) greater palatine and (v) nasopalatine nerves. Although these series of anesthetic injections are effective to anesthetize the tissues of the jaw, they can reach other unwanted structures, such as the upper lip, the nostrils and lower eyelid, causing postoperative discomfort to the patient and minimizing the patient's ability to smile and show the top line of the lip.
In order to minimize the side effects and allow a smaller number of punctures and amount of anesthetic solution used for control the pain in the maxilla, Friedman \& Hochman (1998) described the anterior middle superior alveolar anesthetic technique (AMSA), for various dental procedures in the jaw. The AMSA has the ability to not anesthetize, undesirably, other anatomical structures beyond the periodontium and teeth such as upper lip, bridge of the nose and lower eyelid. This advantage occurs due to the fact that the anesthetic solution is administrated in a small location on the palate where it is not able to reach the sensory fibers of the lips and face and, therefore, does not alter the activity of the muscles that deal with facial expressions. In addition, the administration of only 0.6 to 0.9 ml of anesthetic, is able to induce anesthesia of the pulpal and soft tissues of the palate region. This is a significantly smaller amount of anesthetic than what is usually administered for the desired analgesia for dental and periodontal structures.
The biological plausibility of the AMSA technique is due to the resilience of the tissues of the palate and the application of the anesthetic solution with controlled pressure and flow, so that it reaches the underlying bone and neurovascular anatomy. The penetration of the anesthetic in the tissues from the palate promotes the diffusion of the solution through numerous channels of nutrients and pores in the cortical bone of the palate4. With the spread of the anesthetic in the tissues, structures typically innervated by the anterior superior alveolar nerves, middle and posterior, nasopalatine and greater palatine are anesthetized.
Several reports have suggested that this technique is effective to anesthetize teeth and maxillary tissues extending from the mesial root of first molar to central incisor with a single infiltration. However, there are no controlled studies in the literature that specifically evaluate the vestibular tissue analgesia, considering patient comfort during the procedure for scaling and root planing.
Therefore, the aim of this study was to evaluate the anesthetic efficacy of AMSA technique of tissues at the buccal aspect of the ridge compared to conventional supraperiosteal techniques in the buccal area during the process of scaling and root planing of periodontal pockets in the jaw.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior middle superior alveolar | Experimental | Procedure: Anterior middle superior alveolarThe AMSA technique was performed in the test group according to Friedman \& Hochman (1997). The needle was introduced with the bevel towards the palate tissue with a 45 ° angle and axially rotated (45° clockwise/45° counterclockwise) and 0.6 ml of the anesthetic was slowly infiltrated for 1 minute. In the control group a supraperiosteal infiltration (infiltrative) at the bottom of the vestibule was performed for one minute and 1.8 ml of anesthetic solution was administrated. This amount of anesthetic was divided into doses of 0.6 ml infiltrated, respectively, in the region of the incisors, canines and premolars. After the anesthetic technique, two minutes were expected for the beginning of the periodontal procedure. |
| Supraperiosteal technique | Active comparator | Procedure: Supraperiosteal techniqueThe supraperiosteal technique at the bottom of the vestibule was performed for one minute and 1.8 ml of anesthetic solution was administrated. This amount of anesthetic was divided into doses of 0.6 ml infiltrated, respectively, in the region of the incisors, canines and premolars. After the anesthetic technique, two minutes were expected for the beginning of the SRP procedure. |
Who may qualify
- Ages
- 27 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- localized or generalized periodontal disease;
- ≥ 3 teeth with probing depth ≥ 5 mm in anteroposterior teeth in each maxillary dental arch of the maxilla; a minimum of 6 natural teeth in the maxilla (incisors, canines and premolars);
- good overall systemic health and absence of allergy to any component of the anesthetic used.
Key exclusion criteria (2 listed)
- Patients who had any type of systemic condition that counter indicated periodontal treatment;
- Patients who had taken, within the last 72 hours prior to procedure, any central nervous system depressant, such as alcohol, non-opioid and opioid.
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 |
|---|---|---|
| Anterior middle superior alveolarThe AMSA technique is performed according to Friedman \& Hochman (1997). The needle is introduced with the bevel towards the palate tissue with a 45 ° angle and axially rotated (45° clockwise/45° counterclockwise) and 0.6 ml of the anesthetic was slowly infiltrated for 1 minute. In the control group a supraperiosteal infiltration (infiltrative) at the bottom of the vestibule is performed for one minute and 1.8 ml of anesthetic solution is administrated. This amount of anesthetic is divided into doses of 0.6 ml infiltrated, respectively, in the region of the incisors, canines and premolars. After the anesthetic technique, two minutes would be expected for the beginning of the periodontal procedure. | Procedure or surgery | Anterior middle superior alveolar |
| Supraperiosteal techniqueAlso: Infiltrative techniqueThe supraperiosteal technique is performed at the bottom of the vestibule for one minute and 1.8 ml of anesthetic solution is administrated. This amount of anesthetic is divided into doses of 0.6 ml infiltrated, respectively, in the region of the incisors, canines and premolars. After the anesthetic technique, two minutes would be expected for the beginning of the scaling and root planning procedure. | Procedure or surgery | Supraperiosteal technique |
Primary outcome
Assessment of Severity of Pain
Time frame: 30 minutes after the antesthetic injection
Just after the anesthetic injection the scaling and root planing procedure was performed. The patients were followed by thirty minutes after the beginning of the procedure and the patients expressed pain by placing a vertical line on a visual analogue metric scale (VAS: Visual Analog Scale).
1 secondary outcome
Assessment of the discomfort according to gender
Time frame: 30 minutes after the antesthetic injection
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 5 Dec 2012.
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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.
Maurício Araújo, PhD study chair
State University of Maringá
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior middle superior alveolar and Supraperiosteal technique in people with Periodontal Diseases and Local Anesthesia, run by State University of Maringá at 1 site in Brazil.
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 3 inclusion and 2 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 5 Dec 2012. 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 Brazil. 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?
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?
Assessment of Severity of Pain (time frame: 30 minutes after the antesthetic injection). 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 5 Dec 2012.