Dental CariesNCT04563351
Effectiveness of the Intraligamentary Anesthesia and Inferior Alveolar Nerve Block on Pain During Dental Treatment
A study testing local anaesthetic techniques in people with Dental Caries, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
Objective: To compare the effectiveness and complications of intraligamentary anesthesia (ILA) with conventional inferior alveolar nerve block (IANB) during injection and dental treatment of mandibular posterior teeth. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- local anaesthetic techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2018to 15 Jun 2019
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients requiring regular dental in permanent mandibular posterior teeth under local anesthesia
Who cannot join
- Patients with a clinical or radiographic sign of acute abscess, pus or peri-radicular pathology
- Patients with a systemic disease requiring special considerations during their dental treatment
- Patients with contra-indications for any of the components of the anesthetic solution (allergy to articaine, epinephrine, and sulfite)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial on the Effectiveness of the Intraligamentary Anesthesia and Inferior Alveolar Nerve Block on Pain During Dental Treatment
Objective: To compare the effectiveness and complications of intraligamentary anesthesia (ILA) with conventional inferior alveolar nerve block (IANB) during injection and dental treatment of mandibular posterior teeth.
Materials and Methods: In this randomized, prospective clinical trial, 72 patients (39 males, 33 females) patients scheduled for dental treatment of mandibular posterior teeth, were randomly allocated to ILA group (n=35) received ILA injection or IANB group (n=37) received the conventional IANB. Our primary outcome was to assess pain during the injection as well as pain and stress (discomfort) during dental treatment, using the Numeric Rating Scale (NRS) from 0 to 10 (0 = no pain, 10= the worst pain imaginable). Whereas; recording 24 hours postoperative complications were our Secondary outcomes.
Read the detailed description
MATERIALS AND METHODS This prospective randomized comparative clinical trial was conducted in the integrated clinical course in the dental school of the University of Greifswald, Germany after the approval of the local ethics committee of the medical faculty in Greifswald (No. BB 174/18) in a period from December 2018 to June 2019. The sample size calculation using "G*power version 3.1" (Heinrich-Heine-University / Germany) was based on the following estimates: T-test for means (difference between two independent means), effect size 0.7, α error 0.05 and power (1-ß error) 0.9. It resulted in a samples size of 36 patients in each of the two groups (IANB \& ILA).
Inclusion and Exclusion Criteria The patients requiring regular dental in permanent mandibular posterior teeth under local anesthesia were recruited with an age range of 18 to 50 years. Patients were not included if they had a clinical or radiographic sign of acute abscess, pus or peri-radicular pathology. Also patients with a systemic disease requiring special considerations during their dental treatment or patients with contra-indications for any of the components of the anesthetic solution (allergy to articaine, epinephrine, and sulfite) were excluded.
Clinical Treatment and Outcome Computer-generated randomization technique was applied to allocate the participants to one of the both study groups (ILA vs. IANB). The intensity of pain as well as stress during the injection of the local anesthesia and during the dental procedure was assessed by using the Numeric Rating Scale (NRS 0-10). The anesthesia was performed by the clinical instructors of the course being dental practitioners (GDPs) or by dental students in the 4th and 5th academic year in the integrated clinical course in the dental school of the University of Greifswald and recorded as dentist or student. The distributions of different experience level of clinical instructors, dental students in 4th and 5th year were considered. For the inferior alveolar nerve block, the patient was placed comfortably in a supine position on the dental chair. The start of the anesthetic procedure was done without using topical anesthesia. The IANB injection was administered with cannulas of 38 mm in length and a gauge of 0.4 mm (Sopira Carpule, Heraeus Kulzer GmbH Hanau, Germany). The patients were anesthetized with Ultracain DS Forte 1:100.00 (Sanofi Aventis, Germany), the active ingredient being articaine in 1.7 ml ampules (1 ml equal to 40 mg articaine hydrochloride and 0.012 mg epinephrine hydrochloride, which is included as a vasoconstrictor). Once the bone was contacted, 1.5 ml of anesthetic solution was injected slowly. Subsequently the needle was detached for approximately 1 cm and an addition of 0.3-0.5 ml of local anesthetic solution was injected to anesthetize the lingual nerve.
For the intraligamentary anesthesia, three different syringe systems were used with randomized selection: Softjet syringe (Henke-Sass Wolf, Tuttlingen, Germany), Citojet syringe (Sopira, Heraeus Kulzer GmbH Hanau, Germany), Ultrajet syringe (Sanofi-Aventis, Frankfurt am Main, Germany). The patients were also placed in a supine position and the dentist administered the ILA injection without using topical anesthesia with cannulas of 12 mm in length and a gauge of 0.30 mm (Sopira Carpule, Heraeus Kulzer GmbH Hanau, Germany). Also, Ultracain DS Forte 1:100.000 (Sanofi Aventis, Germany) was used from 1.7 ml ampules. The needle was navigated through the gingival sulcus with the bevel towards the alveolar bone and away from the root surface, at an angle of 30°-40° to the long axis of the tooth and 2- 3 mm into the periodontal ligament space between root and alveolar bone. For each root, 0.2 ml of local anesthetic was injected over at least 20 seconds according to Endo et al. (2008) as well as Bender and Taubenheim (2014).
- Conditions
- Dental Caries
- Being tested
- local anaesthetic techniques
- Keywords
- local anesthetic, dentistry, pain, techniques
- Medical subject headings
- Dental Caries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local anaesthetic techniquesOther
The patients were anesthetized with two different local anaesthetic techniques.
| Study group | Role | What they receive |
|---|---|---|
| conventional inferior alveolar nerve block (IANB) | Active comparator | 37 patients received Inferior Alveolar Nerve Block (IANB) for dental treatment of mandibular posterior teeth. Receives: Other: local anaesthetic techniques |
| Intraligamentary Anesthesia (ILA) | Experimental | 35 patients received Intraligamentary Anesthesia (ILA) for dental treatment of mandibular posterior teeth. Receives: Other: local anaesthetic techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
The intensity of pain during the injection
The intensity of pain during the injection of the LA to be assessed by the patient using Numeric Rating Scale. The Numeric Rating Scale, (NRS 0-10; 0 representing no pain at all and 10 representing the worst pain imaginable) is a valid instrument to measure pain.
Measured: immediately after the injection of LA
The intensity of pain during the dental treatment
The intensity of pain during the dental treatment to be assessed by the patient using Numeric Rating Scale. The Numeric Rating Scale, (NRS 0-10; 0 representing no pain at all and 10 representing the worst pain imaginable) is a valid instrument to measure pain.
Measured: immediately after the dental treatment
The intensity of stress (discomfort)
The intensity of stress during the dental treatment to be assessed by the patient using Numeric Rating Scale. The Numeric Rating Scale, (NRS 0-10; 0 representing no discomfortable at all and 10 representing the maximal discomfortable very imaginable) is a valid instrument to measure stress (discomfort)
Measured: immediately after the dental treatment
Secondary outcomes (1)
Postoperative complications
Recording any postoperative complications which could be occurred (Nerve injury or any other temporary irritations like the pain at the site of injection, signs of intravascular injection, lip-bit injury)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Dec 2018
- Primary completion1 Mar 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies 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
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian splieth, PHD, Study director, University Medicine of Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563351
- Sponsor's protocol ID
- BB 174/18
- Status last verified
- Sep 2020
- First submitted
- 11 Sep 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pradhan R, Kulkarni D, Shetty L. Evaluation of Efficacy of Intraligamentary Injection Technique for Extraction of Mandibular Teeth-A Prospective Study. J Clin Diagn Res. 2017 Jan;11(1):ZC110-ZC113. doi: 10.7860/JCDR/2017/22204.9302. Epub 2017 Jan 1.
PubMed 28274058Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.
PubMed 16000093Siegel K, Schrimshaw EW, Kunzel C, Wolfson NH, Moon-Howard J, Moats HL, Mitchell DA. Types of dental fear as barriers to dental care among African American adults with oral health symptoms in Harlem. J Health Care Poor Underserved. 2012 Aug;23(3):1294-309. doi: 10.1353/hpu.2012.0088.
PubMed 24212175Bahl R. Local anesthesia in dentistry. Anesth Prog. 2004;51(4):138-42. No abstract available.
PubMed 15675263Shabazfar N, Daublander M, Al-Nawas B, Kammerer PW. Periodontal intraligament injection as alternative to inferior alveolar nerve block--meta-analysis of the literature from 1979 to 2012. Clin Oral Investig. 2014;18(2):351-8. doi: 10.1007/s00784-013-1113-1. Epub 2013 Sep 29.
PubMed 24077785Kaufman E, Weinstein P, Milgrom P. Difficulties in achieving local anesthesia. J Am Dent Assoc. 1984 Feb;108(2):205-8. doi: 10.14219/jada.archive.1984.0470. No abstract available.
PubMed 6584494Pogrel MA. Permanent nerve damage from inferior alveolar nerve blocks--an update to include articaine. J Calif Dent Assoc. 2007 Apr;35(4):271-3.
PubMed 17612365Marniemi J, Parkki MG. Radiochemical assay of glutathione S-epoxide transferase and its enhancement by phenobarbital in rat liver in vivo. Biochem Pharmacol. 1975 Sep 1;24(17):1569-72. doi: 10.1016/0006-2952(75)90080-5. No abstract available.
PubMed 9Kämmerer PW, Palarie V, Schiegnitz E, Ziebart T, Al-Nawas B, Daubländer M. Clinical and histological comparison of pulp anesthesia and local diffusion after periodontal ligament injection and intrapapillary infiltration anaesthesia. J Pain Relief. 2012;1(10.4172):2167-0846.
Walton RE, Garnick JJ. The periodontal ligament injection: histologic effects on the periodontium in monkeys. J Endod. 1982 Jan;8(1):22-6. doi: 10.1016/S0099-2399(82)80312-9. No abstract available.
PubMed 6948904Dreyer WP, van Heerden JD, de V Joubert JJ. The route of periodontal ligament injection of local anesthetic solution. J Endod. 1983 Nov;9(11):471-4. doi: 10.1016/S0099-2399(83)80161-7. No abstract available.
PubMed 6586974Kammerer PW, Adubae A, Buttchereit I, Thiem DGE, Daublander M, Frerich B. Prospective clinical study comparing intraligamentary anesthesia and inferior alveolar nerve block for extraction of posterior mandibular teeth. Clin Oral Investig. 2018 Apr;22(3):1469-1475. doi: 10.1007/s00784-017-2248-2. Epub 2017 Oct 15.
PubMed 29034443Meechan JG. Intraligamentary anaesthesia. J Dent. 1992 Dec;20(6):325-32. doi: 10.1016/0300-5712(92)90018-8.
PubMed 1452871Endo T, Gabka J, Taubenheim L. Intraligamentary anesthesia: benefits and limitations. Quintessence Int. 2008 Jan 1;39(1):e15-25.
PubMed 18551207Kammerer PW, Schiegnitz E, von Haussen T, Shabazfar N, Kammerer P, Willershausen B, Al-Nawas B, Daublander M. Clinical efficacy of a computerised device (STA) and a pressure syringe (VarioJect INTRA) for intraligamentary anaesthesia. Eur J Dent Educ. 2015 Feb;19(1):16-22. doi: 10.1111/eje.12096. Epub 2014 Mar 20.
PubMed 24646115
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial on the Effectiveness of the Intraligamentary Anesthesia and Inferior Alveolar Nerve Block on Pain During Dental Treatment
- ClinicalTrials.gov ID
- NCT04563351
- Acronym / sponsor ID
- BB 174/18
- Conditions
- Dental Caries
- Keywords
- local anesthetic, dentistry, pain, techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 24 Sep 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: To compare the effectiveness and complications of intraligamentary anesthesia (ILA) with conventional inferior alveolar nerve block (IANB) during injection and dental treatment of mandibular posterior teeth.
Materials and Methods: In this randomized, prospective clinical trial, 72 patients (39 males, 33 females) patients scheduled for dental treatment of mandibular posterior teeth, were randomly allocated to ILA group (n=35) received ILA injection or IANB group (n=37) received the conventional IANB. Our primary outcome was to assess pain during the injection as well as pain and stress (discomfort) during dental treatment, using the Numeric Rating Scale (NRS) from 0 to 10 (0 = no pain, 10= the worst pain imaginable). Whereas; recording 24 hours postoperative complications were our Secondary outcomes.
Detailed description
MATERIALS AND METHODS This prospective randomized comparative clinical trial was conducted in the integrated clinical course in the dental school of the University of Greifswald, Germany after the approval of the local ethics committee of the medical faculty in Greifswald (No. BB 174/18) in a period from December 2018 to June 2019. The sample size calculation using "G*power version 3.1" (Heinrich-Heine-University / Germany) was based on the following estimates: T-test for means (difference between two independent means), effect size 0.7, α error 0.05 and power (1-ß error) 0.9. It resulted in a samples size of 36 patients in each of the two groups (IANB \& ILA).
Inclusion and Exclusion Criteria The patients requiring regular dental in permanent mandibular posterior teeth under local anesthesia were recruited with an age range of 18 to 50 years. Patients were not included if they had a clinical or radiographic sign of acute abscess, pus or peri-radicular pathology. Also patients with a systemic disease requiring special considerations during their dental treatment or patients with contra-indications for any of the components of the anesthetic solution (allergy to articaine, epinephrine, and sulfite) were excluded.
Clinical Treatment and Outcome Computer-generated randomization technique was applied to allocate the participants to one of the both study groups (ILA vs. IANB). The intensity of pain as well as stress during the injection of the local anesthesia and during the dental procedure was assessed by using the Numeric Rating Scale (NRS 0-10). The anesthesia was performed by the clinical instructors of the course being dental practitioners (GDPs) or by dental students in the 4th and 5th academic year in the integrated clinical course in the dental school of the University of Greifswald and recorded as dentist or student. The distributions of different experience level of clinical instructors, dental students in 4th and 5th year were considered. For the inferior alveolar nerve block, the patient was placed comfortably in a supine position on the dental chair. The start of the anesthetic procedure was done without using topical anesthesia. The IANB injection was administered with cannulas of 38 mm in length and a gauge of 0.4 mm (Sopira Carpule, Heraeus Kulzer GmbH Hanau, Germany). The patients were anesthetized with Ultracain DS Forte 1:100.00 (Sanofi Aventis, Germany), the active ingredient being articaine in 1.7 ml ampules (1 ml equal to 40 mg articaine hydrochloride and 0.012 mg epinephrine hydrochloride, which is included as a vasoconstrictor). Once the bone was contacted, 1.5 ml of anesthetic solution was injected slowly. Subsequently the needle was detached for approximately 1 cm and an addition of 0.3-0.5 ml of local anesthetic solution was injected to anesthetize the lingual nerve.
For the intraligamentary anesthesia, three different syringe systems were used with randomized selection: Softjet syringe (Henke-Sass Wolf, Tuttlingen, Germany), Citojet syringe (Sopira, Heraeus Kulzer GmbH Hanau, Germany), Ultrajet syringe (Sanofi-Aventis, Frankfurt am Main, Germany). The patients were also placed in a supine position and the dentist administered the ILA injection without using topical anesthesia with cannulas of 12 mm in length and a gauge of 0.30 mm (Sopira Carpule, Heraeus Kulzer GmbH Hanau, Germany). Also, Ultracain DS Forte 1:100.000 (Sanofi Aventis, Germany) was used from 1.7 ml ampules. The needle was navigated through the gingival sulcus with the bevel towards the alveolar bone and away from the root surface, at an angle of 30°-40° to the long axis of the tooth and 2- 3 mm into the periodontal ligament space between root and alveolar bone. For each root, 0.2 ml of local anesthetic was injected over at least 20 seconds according to Endo et al. (2008) as well as Bender and Taubenheim (2014).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional inferior alveolar nerve block (IANB) | Active comparator | Other: local anaesthetic techniques37 patients received Inferior Alveolar Nerve Block (IANB) for dental treatment of mandibular posterior teeth. |
| Intraligamentary Anesthesia (ILA) | Experimental | Other: local anaesthetic techniques35 patients received Intraligamentary Anesthesia (ILA) for dental treatment of mandibular posterior teeth. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients requiring regular dental in permanent mandibular posterior teeth under local anesthesia
Key exclusion criteria (3 listed)
- Patients with a clinical or radiographic sign of acute abscess, pus or peri-radicular pathology
- Patients with a systemic disease requiring special considerations during their dental treatment
- Patients with contra-indications for any of the components of the anesthetic solution (allergy to articaine, epinephrine, and sulfite)
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 |
|---|---|---|
| local anaesthetic techniquesThe patients were anesthetized with two different local anaesthetic techniques. | Other | Intraligamentary Anesthesia (ILA), conventional inferior alveolar nerve block (IANB) |
Primary outcome
The intensity of pain during the injection
Time frame: immediately after the injection of LA
The intensity of pain during the injection of the LA to be assessed by the patient using Numeric Rating Scale. The Numeric Rating Scale, (NRS 0-10; 0 representing no pain at all and 10 representing the worst pain imaginable) is a valid instrument to measure pain.
The intensity of pain during the dental treatment
Time frame: immediately after the dental treatment
The intensity of pain during the dental treatment to be assessed by the patient using Numeric Rating Scale. The Numeric Rating Scale, (NRS 0-10; 0 representing no pain at all and 10 representing the worst pain imaginable) is a valid instrument to measure pain.
The intensity of stress (discomfort)
Time frame: immediately after the dental treatment
The intensity of stress during the dental treatment to be assessed by the patient using Numeric Rating Scale. The Numeric Rating Scale, (NRS 0-10; 0 representing no discomfortable at all and 10 representing the maximal discomfortable very imaginable) is a valid instrument to measure stress (discomfort)
1 secondary outcome
Postoperative complications
Time frame: 24 hours
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 24 Sep 2020.
- Results publication: PubMed 28274058Pradhan R, Kulkarni D, Shetty L. Evaluation of Efficacy of Intraligamentary Injection Technique for Extraction of Mandibular Teeth-A Prospective Study. J Clin Diagn Res. 2017 Jan;11(1):ZC110-ZC113. doi: 10.7860/JCDR/2017/22204.9302. Epub 2017 Jan 1.
- Results publication: PubMed 16000093Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.
- Results publication: PubMed 24212175Siegel K, Schrimshaw EW, Kunzel C, Wolfson NH, Moon-Howard J, Moats HL, Mitchell DA. Types of dental fear as barriers to dental care among African American adults with oral health symptoms in Harlem. J Health Care Poor Underserved. 2012 Aug;23(3):1294-309. doi: 10.1353/hpu.2012.0088.
- Results publication: PubMed 15675263Bahl R. Local anesthesia in dentistry. Anesth Prog. 2004;51(4):138-42. No abstract available.
- Results publication: PubMed 24077785Shabazfar N, Daublander M, Al-Nawas B, Kammerer PW. Periodontal intraligament injection as alternative to inferior alveolar nerve block--meta-analysis of the literature from 1979 to 2012. Clin Oral Investig. 2014;18(2):351-8. doi: 10.1007/s00784-013-1113-1. Epub 2013 Sep 29.
- Results publication: PubMed 6584494Kaufman E, Weinstein P, Milgrom P. Difficulties in achieving local anesthesia. J Am Dent Assoc. 1984 Feb;108(2):205-8. doi: 10.14219/jada.archive.1984.0470. No abstract available.
- Results publication: PubMed 17612365Pogrel MA. Permanent nerve damage from inferior alveolar nerve blocks--an update to include articaine. J Calif Dent Assoc. 2007 Apr;35(4):271-3.
- Results publication: PubMed 9Marniemi J, Parkki MG. Radiochemical assay of glutathione S-epoxide transferase and its enhancement by phenobarbital in rat liver in vivo. Biochem Pharmacol. 1975 Sep 1;24(17):1569-72. doi: 10.1016/0006-2952(75)90080-5. No abstract available.
- Results publicationKämmerer PW, Palarie V, Schiegnitz E, Ziebart T, Al-Nawas B, Daubländer M. Clinical and histological comparison of pulp anesthesia and local diffusion after periodontal ligament injection and intrapapillary infiltration anaesthesia. J Pain Relief. 2012;1(10.4172):2167-0846.
- Results publication: PubMed 6948904Walton RE, Garnick JJ. The periodontal ligament injection: histologic effects on the periodontium in monkeys. J Endod. 1982 Jan;8(1):22-6. doi: 10.1016/S0099-2399(82)80312-9. No abstract available.
- Results publication: PubMed 6586974Dreyer WP, van Heerden JD, de V Joubert JJ. The route of periodontal ligament injection of local anesthetic solution. J Endod. 1983 Nov;9(11):471-4. doi: 10.1016/S0099-2399(83)80161-7. No abstract available.
- Results publication: PubMed 29034443Kammerer PW, Adubae A, Buttchereit I, Thiem DGE, Daublander M, Frerich B. Prospective clinical study comparing intraligamentary anesthesia and inferior alveolar nerve block for extraction of posterior mandibular teeth. Clin Oral Investig. 2018 Apr;22(3):1469-1475. doi: 10.1007/s00784-017-2248-2. Epub 2017 Oct 15.
- 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.
Christian splieth, PHD study director
University Medicine of Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local anaesthetic techniques in people with Dental Caries, run by University Medicine Greifswald at 1 site in Germany.
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 3 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 24 Sep 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 Germany. 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?
The intensity of pain during the injection (time frame: immediately after the injection of LA). The study lists 3 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 NCT04563351, which also lists 20 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 24 Sep 2020.