Local Anesthetic EfficacyNCT04465149
Efficacy of Differents Anaesthetics in Mandibular Third Molar Germectomy
A study testing Third Molar Germectomy in people with Local Anesthetic Efficacy, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
Aim: To compare the clinical efficacy of local anaesthetics with articaine 4% or mepivacaine 2% (both with epinephrine 1:100.000) using different anaesthetic techniques to perform germectomy of lower third molars and to assess patients' feelings and pain during surgery. Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Anesthetic Efficacy
- What is being tested?
- Third Molar Germectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jun 2018to 20 Apr 2020
- 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 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients requiring bilateral germectomy of mandibular third molars before orthodontic treatment
Who cannot join
- Patients presenting systemic and oral diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of the Anaesthetic Efficacy of 4% Articaine Versus 2% Mepivacaine in Mandibular Third Molar Germectomy Using Different Anaesthetic Techniques: a Split-mouth Clinical Trial
Aim: To compare the clinical efficacy of local anaesthetics with articaine 4% or mepivacaine 2% (both with epinephrine 1:100.000) using different anaesthetic techniques to perform germectomy of lower third molars and to assess patients' feelings and pain during surgery.
Methods: 50 patients (ranged 11-16 years) who required germectomy of mandibular third molars were recruited. Each patient received local anaesthesia on one side with articaine inoculated with plexus technique while on the other side with mepivacaine using inferior alveolar nerve block technique. The patients' evaluation was performed on pre and intraoperative tactile-pressure feelings and intraoperative pain with four levels on the analogic visual scale (VAS).
Read the detailed description
The surgical extraction of a tooth that exhibits at least a third of its root in formation, with a periodontal ligament discernible on panoramic x-ray, is defined as germectomy. Early germectomy is a usefull intervention to avoid problems caused by lower third molar retention and impaction, and it is often required before or after orthodontic treatment. This surgical technique would also allow to avoid complications, such as inferior alveolar and lingual nerve damage.
The control of the patient's pain and anxiety by using local anaesthesia is essential in oral surgery: these aspects become more important in adolescents, above all in the case of third molar germectomy. Local anaesthetic (LA) injection is often the only painfull part of the dental procedure, and the fear associated with this technique is the main reason that leads patients to avoid dental treatment.
During the execution of dental surgical procedures, anaesthesia of the structures innervated by the mandibular nerve is necessary, and many local anaesthetic techniques are described in the literature. Generally, infiltration plexus technique is usually performed for maxillary procedures while IANB is used for molar mandibular sites with 2% local anaesthetics. Failure rates for IANB are high, sometimes reaching 80% for the lower incisors with this technique, and numerous approaches for the implementation of a new technique of IANB have been described. Among them, the articaine 4% already has been successfully used to achieve local anesthesia and facial infiltration anaesthetic technique in the mandible showed efficacy with encouraging result that can be overlapped to the IANB technique. Articaine (4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride) contains a thiophene ring instead of benzene and an ester group. The thiophene ring allows for higher lipid solubility so a greater portion of an administered dose can enter in neurons. Gazal found that a combination of nerve block anaesthesia, buccal infiltration and intra-ligamentary injection resulted in more profound anaesthesia (P =0.003) and higher success rates compared to IANB alone in mandibular first molar pulp anaesthesia. Other studies reported the use of articaine in implantology interventions in which it was used with subperiosteal technique on the buccal and vestibular sides.
Thus, the literature showed several conflicting results on the mandibular facial plexus infiltration technique used with different anesthetics.
Recent studies of this anaesthetic technique found that 1.8 cc of 4% articaine facial infiltration in the mandible can be effective when the thickness of mandibular facial cortex is < 2.0-3.0 mm, with 5-10 minutes needed for the adequate anaesthesia.
It was reported that many dental procedures on deciduous molars could be accomplished with infiltration of articaine alone in the pediatric population.
As above mentioned, the difficulty in achieving reliable anaesthesia in the third mandibular molars in adults with facial infiltration of local anaesthetic is related to the thickness of the cortical bone and inability to achieve consistently inferior alveolar nerve.
An ideal local anaesthetic should have the following characteristics:
- short latency time;
- strength of the intense effect;
- duration of prolonged action;
- lack of harmful local and systemic effects. Currently, mepivacaine is among the most used and studied anaesthetics in dentistry; however, articaine is nowadays increasingly used for its manageability, lack of side effects and high anaesthetic potency. Mepivacaine is an amide-type anaesthetic with fast action from the beginning and 30-120 minutes duration. Its maximum allowed dose is 300 mg with epinephrine or 500 mg alone. The dose for children is 4-6 mg/kg/dose (maximum: 270 mg) without epinephrine.
Articaine, due to its chemical characteristics, is quickly soluble and rapidly released from adipose/lipid tissue. The ester side chain of articaine is hydrolyzed by plasmaesterases rendering the molecule inactive. Evidence suggests that it is the local anaesthetic that best spreads within soft and hard tissues. Then, it has a non-conducive effect on extended operations having a shorter half-life of 25 minutes compared to approximately 90 minutes of other amides (115 minutes for mepivacaine) that require hepatic clearance. Accordingly, it was suggested that articaine does not own any relevant side effects or systemic toxicities.
For this reason, articaine has been used at higher concentrations (4%), associated with epinephrine, compared to other local dental anesthetics. This higher concentration ensures an excellent spread both in hard and soft tissues, also promoted by a pKa very similar to the physiological pH of tissues. Its great liposolubility allows a rapid diffusion in adipose tissue (spread coefficient = 17,0) and involves a lower adherence to the nerve membranes and, above all, lower toxicity for the tissues. Moreover, articaine has a high protein-based bond (94%) which allows a better affinity for the protein-based membrane receptors, and it is a direct sign of its increased anaesthetic potency.
Dental local anaesthetics are often combined with vasoconstrictors, such as epinephrine, to increase the depth and duration of analgesia. Clinical experiments, in which articaine without vasoconstrictor was used, did not show any satisfying results, whereas the use of articaine combined with low concentrations of vasoconstrictors produced better anaesthetic effects than other common local anaesthetics such as bupivacaine and mepivacaine. It is well documented that vasoconstrictors have a safety range if used at low doses, and not directly injected in the blood vessels, even in particular care patients.
The present study aimed to compare the clinical efficacy of articaine 4% (epinephrine 1:100.000) versus mepivacaine 2% (epinephrine 1:100.000) for the surgical germectomy of mandibular third molars with two different conventional anaesthetic techniques in young patients whom jawbone is not completely mineralized yet and more penetrable by the articaine molecule.
- Conditions
- Local Anesthetic Efficacy
- Being tested
- Third Molar Germectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Third Molar GermectomyProcedure or surgery
Surgical extraction of Third Molars that exhibits at least a third of its root in formation, with a periodontal ligament discernible on panoramic x-ray (defined as germectomy).
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patients who required germectomy of mandibular third molars. Each patient received local anaesthesia on one side with articaine inoculated with plexus technique while on the other side with mepivacaine using inferior alveolar nerve block technique. Receives: Procedure: Third Molar Germectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discomfort/Pain felt for anesthetic injection valued by the Patient on a Visual Analogue Scale
Once performed the injections, patients were asked to notice on a visual analogue scale, how much discomfort they felt due to the anaesthetic injections, indicating one of the following values:
0 absent
- mild
- moderate
- severe
Measured: At the beginning of Surgery
Secondary outcomes (1)
Test during the Surgery
The same test was repeated intraoperatively
Measured: After 10/15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start30 Jun 2018
- Primary completion31 Oct 2019
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Local Anesthetic EfficacyStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The subjects were children undergoing orthodontic treatment in whom early extraction was indicated to facilitate their treatment in some specific conditions (i.e. posterior crowding, altered second molar eruption, non-extraction approach). For each subject, the first germectomy was scheduled 15 days apart. The same senior operator, assisted by the same practitioner, completed all the surgical procedures. All interventions made with mepivacaine were performed with the same anaesthetic technique routinely used in Oral surgery (IANB). The technique was complemented with anaesthesia of the buccal nerve, as routine for this technique, administering another 1.8 ml of the same anaesthetic used in each intervention. On the other hand, the surgical procedures in articaine cases were made practising a plexus technique, performing a deep buccal injection distally to the second mandibular molar.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfredo De Rosa, University of Campania Luigi Vanvitelli
- Investigators
- Marco Menditti, Doctor, Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465149
- Sponsor's protocol ID
- SecondUNI-1
- Status last verified
- Jul 2020
- First submitted
- 7 May 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perillo L, Vitale M, d'Apuzzo F, Isola G, Nucera R, Matarese G. Interdisciplinary approach for a patient with unilateral cleft lip and palate. Am J Orthod Dentofacial Orthop. 2018 Jun;153(6):883-894. doi: 10.1016/j.ajodo.2016.12.035.
PubMed 29853246Raucci G, Pacheco-Pereira C, Elyasi M, d'Apuzzo F, Flores-Mir C, Perillo L. Short- and long-term evaluation of mandibular dental arch dimensional changes in patients treated with a lip bumper during mixed dentition followed by fixed appliances. Angle Orthod. 2016 Sep;86(5):753-60. doi: 10.2319/073015-519.1. Epub 2016 Jan 15.
PubMed 26771718Chiapasco M, Crescentini M, Romanoni G. [The extraction of the lower third molars: germectomy or late avulsion?]. Minerva Stomatol. 1994 May;43(5):191-8. Italian.
PubMed 8072466Rayati F, Noruziha A, Jabbarian R. Efficacy of buccal infiltration anaesthesia with articaine for extraction of mandibular molars: a clinical trial. Br J Oral Maxillofac Surg. 2018 Sep;56(7):607-610. doi: 10.1016/j.bjoms.2018.06.012. Epub 2018 Jul 3.
PubMed 29980352Almpani K, Kolokitha OE. Role of third molars in orthodontics. World J Clin Cases. 2015 Feb 16;3(2):132-40. doi: 10.12998/wjcc.v3.i2.132.
PubMed 25685759Bjornland T, Haanaes HR, Lind PO, Zachrisson B. Removal of third molar germs. Study of complications. Int J Oral Maxillofac Surg. 1987 Aug;16(4):385-90. doi: 10.1016/s0901-5027(87)80072-3.
PubMed 3117908Eccleston C. Role of psychology in pain management. Br J Anaesth. 2001 Jul;87(1):144-52. doi: 10.1093/bja/87.1.144.
PubMed 11460803Gunter JB. Benefit and risks of local anesthetics in infants and children. Paediatr Drugs. 2002;4(10):649-72. doi: 10.2165/00128072-200204100-00003.
PubMed 12269841Milgrom P, Coldwell SE, Getz T, Weinstein P, Ramsay DS. Four dimensions of fear of dental injections. J Am Dent Assoc. 1997 Jun;128(6):756-66. doi: 10.14219/jada.archive.1997.0301.
PubMed 9188235Kaufman E, Epstein JB, Naveh E, Gorsky M, Gross A, Cohen G. A survey of pain, pressure, and discomfort induced by commonly used oral local anesthesia injections. Anesth Prog. 2005 Winter;52(4):122-7. doi: 10.2344/0003-3006(2005)52[122:ASP]2.0.CO;2.
PubMed 16596910Khoury J, Townsend G. Neural blockade anaesthesia of the mandibular nerve and its terminal branches: rationale for different anaesthetic techniques including their advantages and disadvantages. Anesthesiol Res Pract. 2011;2011:307423. doi: 10.1155/2011/307423. Epub 2011 May 25.
PubMed 21716730Flanagan DF. The effectiveness of articaine in mandibular facial infiltrations. Local Reg Anesth. 2015 Dec 18;9:1-6. doi: 10.2147/LRA.S94647. eCollection 2016.
PubMed 26730209Saxena P, Gupta SK, Newaskar V, Chandra A. Advances in dental local anesthesia techniques and devices: An update. Natl J Maxillofac Surg. 2013 Jan;4(1):19-24. doi: 10.4103/0975-5950.117873.
PubMed 24163548Meechan JG. The use of the mandibular infiltration anesthetic technique in adults. J Am Dent Assoc. 2011 Sep;142 Suppl 3:19S-24S. doi: 10.14219/jada.archive.2011.0343.
PubMed 21881058Malamed SF. Is the mandibular nerve block passe? J Am Dent Assoc. 2011 Sep;142 Suppl 3:3S-7S. doi: 10.14219/jada.archive.2011.0340.
PubMed 21881055
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Anaesthetic Efficacy of 4% Articaine Versus 2% Mepivacaine in Mandibular Third Molar Germectomy Using Different Anaesthetic Techniques: a Split-mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT04465149
- Acronym / sponsor ID
- SecondUNI-1
- Conditions
- Local Anesthetic Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 9 Jul 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.
Aim: To compare the clinical efficacy of local anaesthetics with articaine 4% or mepivacaine 2% (both with epinephrine 1:100.000) using different anaesthetic techniques to perform germectomy of lower third molars and to assess patients' feelings and pain during surgery.
Methods: 50 patients (ranged 11-16 years) who required germectomy of mandibular third molars were recruited. Each patient received local anaesthesia on one side with articaine inoculated with plexus technique while on the other side with mepivacaine using inferior alveolar nerve block technique. The patients' evaluation was performed on pre and intraoperative tactile-pressure feelings and intraoperative pain with four levels on the analogic visual scale (VAS).
Detailed description
The surgical extraction of a tooth that exhibits at least a third of its root in formation, with a periodontal ligament discernible on panoramic x-ray, is defined as germectomy. Early germectomy is a usefull intervention to avoid problems caused by lower third molar retention and impaction, and it is often required before or after orthodontic treatment. This surgical technique would also allow to avoid complications, such as inferior alveolar and lingual nerve damage.
The control of the patient's pain and anxiety by using local anaesthesia is essential in oral surgery: these aspects become more important in adolescents, above all in the case of third molar germectomy. Local anaesthetic (LA) injection is often the only painfull part of the dental procedure, and the fear associated with this technique is the main reason that leads patients to avoid dental treatment.
During the execution of dental surgical procedures, anaesthesia of the structures innervated by the mandibular nerve is necessary, and many local anaesthetic techniques are described in the literature. Generally, infiltration plexus technique is usually performed for maxillary procedures while IANB is used for molar mandibular sites with 2% local anaesthetics. Failure rates for IANB are high, sometimes reaching 80% for the lower incisors with this technique, and numerous approaches for the implementation of a new technique of IANB have been described. Among them, the articaine 4% already has been successfully used to achieve local anesthesia and facial infiltration anaesthetic technique in the mandible showed efficacy with encouraging result that can be overlapped to the IANB technique. Articaine (4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride) contains a thiophene ring instead of benzene and an ester group. The thiophene ring allows for higher lipid solubility so a greater portion of an administered dose can enter in neurons. Gazal found that a combination of nerve block anaesthesia, buccal infiltration and intra-ligamentary injection resulted in more profound anaesthesia (P =0.003) and higher success rates compared to IANB alone in mandibular first molar pulp anaesthesia. Other studies reported the use of articaine in implantology interventions in which it was used with subperiosteal technique on the buccal and vestibular sides.
Thus, the literature showed several conflicting results on the mandibular facial plexus infiltration technique used with different anesthetics.
Recent studies of this anaesthetic technique found that 1.8 cc of 4% articaine facial infiltration in the mandible can be effective when the thickness of mandibular facial cortex is < 2.0-3.0 mm, with 5-10 minutes needed for the adequate anaesthesia.
It was reported that many dental procedures on deciduous molars could be accomplished with infiltration of articaine alone in the pediatric population.
As above mentioned, the difficulty in achieving reliable anaesthesia in the third mandibular molars in adults with facial infiltration of local anaesthetic is related to the thickness of the cortical bone and inability to achieve consistently inferior alveolar nerve.
An ideal local anaesthetic should have the following characteristics:
- short latency time;
- strength of the intense effect;
- duration of prolonged action;
- lack of harmful local and systemic effects. Currently, mepivacaine is among the most used and studied anaesthetics in dentistry; however, articaine is nowadays increasingly used for its manageability, lack of side effects and high anaesthetic potency. Mepivacaine is an amide-type anaesthetic with fast action from the beginning and 30-120 minutes duration. Its maximum allowed dose is 300 mg with epinephrine or 500 mg alone. The dose for children is 4-6 mg/kg/dose (maximum: 270 mg) without epinephrine.
Articaine, due to its chemical characteristics, is quickly soluble and rapidly released from adipose/lipid tissue. The ester side chain of articaine is hydrolyzed by plasmaesterases rendering the molecule inactive. Evidence suggests that it is the local anaesthetic that best spreads within soft and hard tissues. Then, it has a non-conducive effect on extended operations having a shorter half-life of 25 minutes compared to approximately 90 minutes of other amides (115 minutes for mepivacaine) that require hepatic clearance. Accordingly, it was suggested that articaine does not own any relevant side effects or systemic toxicities.
For this reason, articaine has been used at higher concentrations (4%), associated with epinephrine, compared to other local dental anesthetics. This higher concentration ensures an excellent spread both in hard and soft tissues, also promoted by a pKa very similar to the physiological pH of tissues. Its great liposolubility allows a rapid diffusion in adipose tissue (spread coefficient = 17,0) and involves a lower adherence to the nerve membranes and, above all, lower toxicity for the tissues. Moreover, articaine has a high protein-based bond (94%) which allows a better affinity for the protein-based membrane receptors, and it is a direct sign of its increased anaesthetic potency.
Dental local anaesthetics are often combined with vasoconstrictors, such as epinephrine, to increase the depth and duration of analgesia. Clinical experiments, in which articaine without vasoconstrictor was used, did not show any satisfying results, whereas the use of articaine combined with low concentrations of vasoconstrictors produced better anaesthetic effects than other common local anaesthetics such as bupivacaine and mepivacaine. It is well documented that vasoconstrictors have a safety range if used at low doses, and not directly injected in the blood vessels, even in particular care patients.
The present study aimed to compare the clinical efficacy of articaine 4% (epinephrine 1:100.000) versus mepivacaine 2% (epinephrine 1:100.000) for the surgical germectomy of mandibular third molars with two different conventional anaesthetic techniques in young patients whom jawbone is not completely mineralized yet and more penetrable by the articaine molecule.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The subjects were children undergoing orthodontic treatment in whom early extraction was indicated to facilitate their treatment in some specific conditions (i.e. posterior crowding, altered second molar eruption, non-extraction approach). For each subject, the first germectomy was scheduled 15 days apart. The same senior operator, assisted by the same practitioner, completed all the surgical procedures. All interventions made with mepivacaine were performed with the same anaesthetic technique routinely used in Oral surgery (IANB). The technique was complemented with anaesthesia of the buccal nerve, as routine for this technique, administering another 1.8 ml of the same anaesthetic used in each intervention. On the other hand, the surgical procedures in articaine cases were made practising a plexus technique, performing a deep buccal injection distally to the second mandibular molar.
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Procedure: Third Molar GermectomyPatients who required germectomy of mandibular third molars. Each patient received local anaesthesia on one side with articaine inoculated with plexus technique while on the other side with mepivacaine using inferior alveolar nerve block technique. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients requiring bilateral germectomy of mandibular third molars before orthodontic treatment
Key exclusion criteria (1 listed)
- Patients presenting systemic and oral diseases
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 |
|---|---|---|
| Third Molar GermectomySurgical extraction of Third Molars that exhibits at least a third of its root in formation, with a periodontal ligament discernible on panoramic x-ray (defined as germectomy). | Procedure or surgery | Patients |
Primary outcome
Discomfort/Pain felt for anesthetic injection valued by the Patient on a Visual Analogue Scale
Time frame: At the beginning of Surgery
Once performed the injections, patients were asked to notice on a visual analogue scale, how much discomfort they felt due to the anaesthetic injections, indicating one of the following values: 0 absent 1. mild 2. moderate 3. severe
1 secondary outcome
Test during the Surgery
Time frame: After 10/15 minutes
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 9 Jul 2020.
- Results publication: PubMed 29853246Perillo L, Vitale M, d'Apuzzo F, Isola G, Nucera R, Matarese G. Interdisciplinary approach for a patient with unilateral cleft lip and palate. Am J Orthod Dentofacial Orthop. 2018 Jun;153(6):883-894. doi: 10.1016/j.ajodo.2016.12.035.
- Results publication: PubMed 26771718Raucci G, Pacheco-Pereira C, Elyasi M, d'Apuzzo F, Flores-Mir C, Perillo L. Short- and long-term evaluation of mandibular dental arch dimensional changes in patients treated with a lip bumper during mixed dentition followed by fixed appliances. Angle Orthod. 2016 Sep;86(5):753-60. doi: 10.2319/073015-519.1. Epub 2016 Jan 15.
- Results publication: PubMed 8072466Chiapasco M, Crescentini M, Romanoni G. [The extraction of the lower third molars: germectomy or late avulsion?]. Minerva Stomatol. 1994 May;43(5):191-8. Italian.
- Results publication: PubMed 29980352Rayati F, Noruziha A, Jabbarian R. Efficacy of buccal infiltration anaesthesia with articaine for extraction of mandibular molars: a clinical trial. Br J Oral Maxillofac Surg. 2018 Sep;56(7):607-610. doi: 10.1016/j.bjoms.2018.06.012. Epub 2018 Jul 3.
- Results publication: PubMed 25685759Almpani K, Kolokitha OE. Role of third molars in orthodontics. World J Clin Cases. 2015 Feb 16;3(2):132-40. doi: 10.12998/wjcc.v3.i2.132.
- Results publication: PubMed 3117908Bjornland T, Haanaes HR, Lind PO, Zachrisson B. Removal of third molar germs. Study of complications. Int J Oral Maxillofac Surg. 1987 Aug;16(4):385-90. doi: 10.1016/s0901-5027(87)80072-3.
- Results publication: PubMed 11460803Eccleston C. Role of psychology in pain management. Br J Anaesth. 2001 Jul;87(1):144-52. doi: 10.1093/bja/87.1.144.
- Results publication: PubMed 12269841Gunter JB. Benefit and risks of local anesthetics in infants and children. Paediatr Drugs. 2002;4(10):649-72. doi: 10.2165/00128072-200204100-00003.
- Results publication: PubMed 9188235Milgrom P, Coldwell SE, Getz T, Weinstein P, Ramsay DS. Four dimensions of fear of dental injections. J Am Dent Assoc. 1997 Jun;128(6):756-66. doi: 10.14219/jada.archive.1997.0301.
- Results publication: PubMed 16596910Kaufman E, Epstein JB, Naveh E, Gorsky M, Gross A, Cohen G. A survey of pain, pressure, and discomfort induced by commonly used oral local anesthesia injections. Anesth Prog. 2005 Winter;52(4):122-7. doi: 10.2344/0003-3006(2005)52[122:ASP]2.0.CO;2.
- Results publication: PubMed 21716730Khoury J, Townsend G. Neural blockade anaesthesia of the mandibular nerve and its terminal branches: rationale for different anaesthetic techniques including their advantages and disadvantages. Anesthesiol Res Pract. 2011;2011:307423. doi: 10.1155/2011/307423. Epub 2011 May 25.
- Results publication: PubMed 26730209Flanagan DF. The effectiveness of articaine in mandibular facial infiltrations. Local Reg Anesth. 2015 Dec 18;9:1-6. doi: 10.2147/LRA.S94647. eCollection 2016.
- Individual participant dataSharing planned: No
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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.
Marco Menditti, Doctor principal investigator
University of Campania Luigi Vanvitelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Third Molar Germectomy in people with Local Anesthetic Efficacy, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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 9 Jul 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 Italy. 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?
Discomfort/Pain felt for anesthetic injection valued by the Patient on a Visual Analogue Scale (time frame: At the beginning of Surgery). 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 NCT04465149, which also lists 38 linked publications.
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 9 Jul 2020.