Anesthesia, LocalNCT05115773
Comparison of The Effectiveness of Intraligamentary and Mandibular Anesthesia on Mandibular Molar Teeth
A study testing Intraligamentary anaesthesia and Mandibular anaesthesia in people with Anesthesia, Local, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to compare the effects of mandibular and intraligamentary anesthesia techniques on pain scores during restorative treatment of permanent mandibular molars in pediatric patients. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Intraligamentary anaesthesia and Mandibular anaesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2020to 31 Aug 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects with American Society of Anesthesiologists score I (ASA I)
- Subjects with Frankl's behavior rate III (positive) and IV (definitely positive),
- Subjects with indication of similar restoration treatment on bilateral first permanent mandibular molars
- Subjects whose plaque index score of 0 (no plaque) and 1
- Subjects whose gingival index score of 0
Who cannot join
- Allergic to the local anesthetics or sulfites
- Subjects with cholinesterase deficiency
- Subjects who use drugs that may affect the assessment of pain, such as narcotic or non-narcotic analgesic, anti-inflammatory, anxiolytic, antipsychotic and antihistamine agents
- Subjects who need to use sedatives or other medications during dental procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of The Effectiveness of Intraligamentary and Mandibular Anesthesia on Mandibular Molar Teeth: A Randomized Clinical Study
This study aimed to compare the effects of mandibular and intraligamentary anesthesia techniques on pain scores during restorative treatment of permanent mandibular molars in pediatric patients. Additionally, comparing the anesthesia techniques in terms of injection pain, the success of anesthesia, postoperative complications, and the subjects' preference was planned.
This randomized, controlled, cross-over, single-blind, split-mouth study was conducted on 78 subjects aged 6 to 12 years. Subjects with enamel-dentin caries on the bilateral permanent mandibular molar were included.
Read the detailed description
First, the subjects who met the inclusion criteria in the study were included in 2 study groups according to age, gender, dental experience, DMFT / dmft values, and ICDAS II and radiographic evaluation criteria. Two different anesthesia techniques were applied to the right / left permanent first molar teeth of the patients included in the study, with an interval of one week. The subjects have been divided into two groups as 39 subjects were Group 1 received intraligamentary anesthesia in the first visit, and 39 subjects were Group 2 received mandibular anesthesia in the first session. The pain perception rates of the patients during the injection and treatment phases were recorded subjectively using a visual analog scale and Wong-Baker FACES pain rating scale. Heart rate and arterial oxygen saturation were determined as the physiological parameters. The quality of anesthesia and success were evaluated by the operation at the end of each visit. Complications (pain, raised teeth, hematoma, trauma due to lip/tongue bites, swelling, infection, and bleeding) were explained to the patients after anesthesia. They were asked to take note of the complications they encountered. Postoperative complications were recorded by calling the cases 1 day after the 1st and 2nd visits. At the end of the second visit, anesthesia preference of the patient was asked and recorded.
- Conditions
- Anesthesia, Local
- Being tested
- Intraligamentary anaesthesia, Mandibular anaesthesia
- Keywords
- intraligamentary anesthesia, inferior alveolar nerve block, paediatric dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraligamentary anaesthesiaProcedure or surgery
Also called 2 or 4 points intraligamentary injection
one tooth anaesthesia by 2 or 4 points intraligamentary injection
Mandibular anaesthesiaProcedure or surgery
Also called Inferior alveolar nerve block
Inferior alveolar nerve block by direct standart method
| Study group | Role | What they receive |
|---|---|---|
| Intraligamentary Anaesthesia | Experimental | Before the restorative treatment of mandibular first molar, SOPIRA® 30 gauge extra-short cartridge needle attached to the tip of the SOPIRA® Citoject (SOPIRA® Heraeus Kulzer, Hanau, Almanya) pressure injector will be inserted into the periodontal sulcus 1-2 mm until resistance. The needle will be at an angle of 30 degrees to the long axis of the tooth. As recommended by the manufacturer, a total of 0.36 ml (mesiobuccal and distobuccal) 4% articaine solution containing 1:100,000 epinephrine (Ultracaine DS forte cartridge, Sanofi-Aventis GmbH, Almanya) will be injected slowly over 42 seconds by pressing the dosing lever 3 times for each root. If the anaesthesia will be failed, we would use the 4-point IL injection by injecting the mesiolingual sulcus and distolingual sulcus with the same technique. Receives: Procedure: Intraligamentary anaesthesia |
| Mandibular Anaesthesia | Active comparator | Before the restorative treatment of mandibular first molar, inferior alveolar nerve block will be provided using the direct standard method. The 27 gauge needle of a 2ml disposable plastic syringe (Ayset, Adana, Turkey) enters from the intersection of the internal oblique edge and the midline of the pterygomandibular raphe, and 1 ml of 4% articaine solution containing1:100,000 epinephrine (Ultracaine DS Forte ampul, Sanofi-Aventis GmbH, Almanya) will be injected slowly in 60 seconds. 15 minutes after the injection the anaesthesia of the lip/tongue will be checked by probing the labial mucosa of the ipsilateral canine tooth. Receives: Procedure: Mandibular anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurements of dental pain using Visual Analogue Scale
Subjective pain perception scores during the intervention using Visual Analogue Scale containing Numeric Rating Scale (0-10, where 0 means no pain/best, 10 - worst possible pain)
Measured: Immediately after the working with a low-speed rotary instrument on dentin
The measurements of injection pain using Visual Analogue Scale
Subjective pain perception scores after the local anesthetic injection using Visual Analogue Scale containing Numeric Rating Scale (0-10, where 0 means no pain/best, 10 - worst possible pain)
Measured: Immediately after the local anaesthetic injection
Measurement of the pain perception during the dental procedures using Wong Baker FACES pain rating scale.
Subjective pain perception scores using Wong Baker Faces pain rating scale (Face 0: it does not hurt/best, Face 2: it hurts a little, Face 4: it hurts a little more, Face 6: it hurts more, Face 8: it hurts a lot, Face 10: it hurts a lot/worst)
Measured: Immediately after the working with a low-speed rotary instrument on dentin
Measurement of the injection pain of the local anesthesia using Wong Baker FACES pain rating scale.
Subjective pain perception scores using Wong Baker Faces pain rating scale (Face 0: it does not hurt/best, Face 2: it hurts a little, Face 4: it hurts a little more, Face 6: it hurts more, Face 8: it hurts a lot, Face 10: it hurts a lot/worst)
Measured: Immediately after the local anaesthetic injection
Change from baseline physiological parameters (arterial oxygen saturation and pulse rate) at the end of the working with a low-speed rotary instrument on dentin
Measurement of arterial oxygen saturation and pulse rate using a pulse oximeter
Measured: Baseline and immediately after the working with a low-speed rotary instrument on dentin
Change from baseline physiological parameters (arterial oxygen saturation and pulse rate) at the end of the working with a low-speed rotary instrument on dentin
Measurement of arterial oxygen saturation and pulse rate using a pulse oximeter
Measured: Baseline and immediately after the local anaesthetic injection
Practitioner's assessment of patient pain-related comfort
Practitioner's subjective records: cases who need additional mandibular anaesthesia, whose treatment is completed without a discomfort related to pain, who has a slight discomfort even though additional mandibular anaesthesia is not needed during the treatment
Measured: Immediately after the dental treatment
Rate of post-op complication
Query the presence of post-op complications related to local anaesthesia
Measured: Day after intervention
Secondary outcomes (1)
Evaluate the correlation between two self reported objective pain scales
The correlation between the scores of Wong Baker Faces pain rating scale (Face 0: it does not hurt/best, Face 2: it hurts a little, Face 4: it hurts a little more, Face 6: it hurts more, Face 8: it hurts a lot, Face 10: it hurts a lot/worst) and Visual Analogue Scale for pain (0-10, where 0 means no pain/best, 10 - worst possible pain) recorded after the local anaesthetic injection in 6-12 years old patients. For the Wong Baker FACES pain rating scale, the maximum value (10) means "it hurt a lot" is the worst and the minimum value (0) means "it does not hurt" is the best outcome. For the Visual Analogue Scale for pain containing Numeric Rating Scale , while the minimum value (0) means "no pain" is the best outcome, the maximum value (10) means "worst possible pain" is the worst outcome.
Measured: Immediately after the local anaesthetic injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start25 Feb 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies 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
- Crossover
- Model description
- randomized controlled, single-blind, split-mouth clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda Cagırır Dindaroglu, Izmir Katip Celebi University
- Investigators
- Funda Çağırır Dindaroğlu, Asst. Prof., Study director, İzmir Katip Çelebi University Faculty of DentistryEce Yılmaz, DDS, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115773
- Sponsor's protocol ID
- 2019-TDU-DİŞF-0013
- Status last verified
- Nov 2021
- First submitted
- 14 Sep 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Effectiveness of Intraligamentary and Mandibular Anesthesia on Mandibular Molar Teeth: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05115773
- Acronym / sponsor ID
- 2019-TDU-DİŞF-0013
- Conditions
- Anesthesia, Local
- Keywords
- intraligamentary anesthesia, inferior alveolar nerve block, paediatric dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 10 Nov 2021 (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.
This study aimed to compare the effects of mandibular and intraligamentary anesthesia techniques on pain scores during restorative treatment of permanent mandibular molars in pediatric patients. Additionally, comparing the anesthesia techniques in terms of injection pain, the success of anesthesia, postoperative complications, and the subjects' preference was planned.
This randomized, controlled, cross-over, single-blind, split-mouth study was conducted on 78 subjects aged 6 to 12 years. Subjects with enamel-dentin caries on the bilateral permanent mandibular molar were included.
Detailed description
First, the subjects who met the inclusion criteria in the study were included in 2 study groups according to age, gender, dental experience, DMFT / dmft values, and ICDAS II and radiographic evaluation criteria. Two different anesthesia techniques were applied to the right / left permanent first molar teeth of the patients included in the study, with an interval of one week. The subjects have been divided into two groups as 39 subjects were Group 1 received intraligamentary anesthesia in the first visit, and 39 subjects were Group 2 received mandibular anesthesia in the first session. The pain perception rates of the patients during the injection and treatment phases were recorded subjectively using a visual analog scale and Wong-Baker FACES pain rating scale. Heart rate and arterial oxygen saturation were determined as the physiological parameters. The quality of anesthesia and success were evaluated by the operation at the end of each visit. Complications (pain, raised teeth, hematoma, trauma due to lip/tongue bites, swelling, infection, and bleeding) were explained to the patients after anesthesia. They were asked to take note of the complications they encountered. Postoperative complications were recorded by calling the cases 1 day after the 1st and 2nd visits. At the end of the second visit, anesthesia preference of the patient was asked and recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled, single-blind, split-mouth clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intraligamentary Anaesthesia | Experimental | Procedure: Intraligamentary anaesthesiaBefore the restorative treatment of mandibular first molar, SOPIRA® 30 gauge extra-short cartridge needle attached to the tip of the SOPIRA® Citoject (SOPIRA® Heraeus Kulzer, Hanau, Almanya) pressure injector will be inserted into the periodontal sulcus 1-2 mm until resistance. The needle will be at an angle of 30 degrees to the long axis of the tooth. As recommended by the manufacturer, a total of 0.36 ml (mesiobuccal and distobuccal) 4% articaine solution containing 1:100,000 epinephrine (Ultracaine DS forte cartridge, Sanofi-Aventis GmbH, Almanya) will be injected slowly over 42 seconds by pressing the dosing lever 3 times for each root. If the anaesthesia will be failed, we would use the 4-point IL injection by injecting the mesiolingual sulcus and distolingual sulcus with the same technique. |
| Mandibular Anaesthesia | Active comparator | Procedure: Mandibular anaesthesiaBefore the restorative treatment of mandibular first molar, inferior alveolar nerve block will be provided using the direct standard method. The 27 gauge needle of a 2ml disposable plastic syringe (Ayset, Adana, Turkey) enters from the intersection of the internal oblique edge and the midline of the pterygomandibular raphe, and 1 ml of 4% articaine solution containing1:100,000 epinephrine (Ultracaine DS Forte ampul, Sanofi-Aventis GmbH, Almanya) will be injected slowly in 60 seconds. 15 minutes after the injection the anaesthesia of the lip/tongue will be checked by probing the labial mucosa of the ipsilateral canine tooth. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects with American Society of Anesthesiologists score I (ASA I)
- Subjects with Frankl's behavior rate III (positive) and IV (definitely positive),
- Subjects with indication of similar restoration treatment on bilateral first permanent mandibular molars
- Subjects whose plaque index score of 0 (no plaque) and 1
- Subjects whose gingival index score of 0
Key exclusion criteria (4 listed)
- Allergic to the local anesthetics or sulfites
- Subjects with cholinesterase deficiency
- Subjects who use drugs that may affect the assessment of pain, such as narcotic or non-narcotic analgesic, anti-inflammatory, anxiolytic, antipsychotic and antihistamine agents
- Subjects who need to use sedatives or other medications during dental procedures
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 |
|---|---|---|
| Intraligamentary anaesthesiaAlso: 2 or 4 points intraligamentary injectionone tooth anaesthesia by 2 or 4 points intraligamentary injection | Procedure or surgery | Intraligamentary Anaesthesia |
| Mandibular anaesthesiaAlso: Inferior alveolar nerve blockInferior alveolar nerve block by direct standart method | Procedure or surgery | Mandibular Anaesthesia |
Primary outcome
The measurements of dental pain using Visual Analogue Scale
Time frame: Immediately after the working with a low-speed rotary instrument on dentin
Subjective pain perception scores during the intervention using Visual Analogue Scale containing Numeric Rating Scale (0-10, where 0 means no pain/best, 10 - worst possible pain)
The measurements of injection pain using Visual Analogue Scale
Time frame: Immediately after the local anaesthetic injection
Subjective pain perception scores after the local anesthetic injection using Visual Analogue Scale containing Numeric Rating Scale (0-10, where 0 means no pain/best, 10 - worst possible pain)
Measurement of the pain perception during the dental procedures using Wong Baker FACES pain rating scale.
Time frame: Immediately after the working with a low-speed rotary instrument on dentin
Subjective pain perception scores using Wong Baker Faces pain rating scale (Face 0: it does not hurt/best, Face 2: it hurts a little, Face 4: it hurts a little more, Face 6: it hurts more, Face 8: it hurts a lot, Face 10: it hurts a lot/worst)
Measurement of the injection pain of the local anesthesia using Wong Baker FACES pain rating scale.
Time frame: Immediately after the local anaesthetic injection
Subjective pain perception scores using Wong Baker Faces pain rating scale (Face 0: it does not hurt/best, Face 2: it hurts a little, Face 4: it hurts a little more, Face 6: it hurts more, Face 8: it hurts a lot, Face 10: it hurts a lot/worst)
Change from baseline physiological parameters (arterial oxygen saturation and pulse rate) at the end of the working with a low-speed rotary instrument on dentin
Time frame: Baseline and immediately after the working with a low-speed rotary instrument on dentin
Measurement of arterial oxygen saturation and pulse rate using a pulse oximeter
Change from baseline physiological parameters (arterial oxygen saturation and pulse rate) at the end of the working with a low-speed rotary instrument on dentin
Time frame: Baseline and immediately after the local anaesthetic injection
Measurement of arterial oxygen saturation and pulse rate using a pulse oximeter
Practitioner's assessment of patient pain-related comfort
Time frame: Immediately after the dental treatment
Practitioner's subjective records: cases who need additional mandibular anaesthesia, whose treatment is completed without a discomfort related to pain, who has a slight discomfort even though additional mandibular anaesthesia is not needed during the treatment
Rate of post-op complication
Time frame: Day after intervention
Query the presence of post-op complications related to local anaesthesia
1 secondary outcome
Evaluate the correlation between two self reported objective pain scales
Time frame: Immediately after the local anaesthetic 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 17 Nov 2021.
Related trials for Anesthesia, Local
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
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.
Funda Çağırır Dindaroğlu, Asst. Prof. study director
İzmir Katip Çelebi University Faculty of Dentistry
Ece Yılmaz, DDS principal investigator
Private Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraligamentary anaesthesia and Mandibular anaesthesia in people with Anesthesia, Local, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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 17 Nov 2021. 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 Turkey (Türkiye). 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 measurements of dental pain using Visual Analogue Scale (time frame: Immediately after the working with a low-speed rotary instrument on dentin). The study lists 8 primary outcomes in all. 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 17 Nov 2021.