Anomalies of the Mouth

Common natal anomalies of the mouth

  • anomalies in 50% of neonates
  • 43% palatine cysts
  • 26% alveolar cysts
  • 9% ankyloglossia
  • 2 neonates had congenital eruption cyst

Effectiveness of 2% Articaine as an anesthetic agent in Children: Randomised Controlled Trial

By Ramadurai et al. 2018 – Clinical Oral Investigations – Pure Dentistry Journal Club, October 2019

Introduction

  • dental pain in an anxious patient can ↑ pain during treatment
  • providing dental treatment with minimal discomfort
  • positive dental experience for the child
  • mechanism of action of LA:
  • conduction blockade
  • ↓permeability of ion channels to sodium ions
  • Lignocaine:
  • Introduced in 1948
  • gold standard
  • most commonly used
  • amide based

Articaine

  • H. Rusching et al. 1969
  • amide base
  • ↑ intraneural concentration
  • ↑ extensive longitudinal spreading
  • better conduction blockade

Oertal & Kirch 1997

  • thiophene ring ↑ liposolubility & potency
  • incorporated extra ester linkage →rapid biotransformation in liver and plasma
  • ↓ systemic toxicity
  • equal analgesic efficacy & lower systemic toxicity
  • used in higher concentrations compared to other amide anesthetics

Oertal & Kirch 1997

  • thiophene ring ↑ liposolubility & potency
  • incorporated extra ester linkage →rapid biotransformation in liver and plasma
  • ↓ systemic toxicity
  • equal analgesic efficacy & lower systemic toxicity
  • used in higher concentrations compared to other amide anesthetics

Oertal & Kirch 1997

  • possible nerve damage in 4% concentration

Garisto et al.  2010

  • lower concentrations → less effective :
  • time of onset
  • duration
  • effectiveness

Malamed 2000

Aim

determine the effectiveness of 2% articaine by comparing it to 2% lignocaine (gold standard) in achieving adequate anesthesia in children

Materials & Methods

  • parallel group randomized controlled
  • Saveetha dental college and hospital
  • routine dental treatment

inclusion criteria:

  • 6 yrs & above
  • cooperative behavior under LA
  • pulp therapy or extraction of mandibular molar requiring IANB
  • parallel group randomized controlled
  • Saveetha dental college and hospital
  • routine dental treatment

exclusion criteria

  • less than 20 kg
  • allergy to LA
  • pulp therapy of abscessed tooth/non vital pulp
  • RCT or extraction of permanent teeth
  • aversive conditioning
  • medical conditions contraindicating use of LA
  • consent from parents
  • ethics approved
  • study registered
  • recruitment for patients from Dec 2014-Oct 2015

Sample Size

  • estimated 76 per group
  • 90% power & 95% confidence interval
  • 10% adjustment for losses→ 90 participants

Randomisation

  • 2 groups
  • computer generated random block design
  • blocks of 6
  • 3 in group A and B

Preparation & Blinding

  • 4% articaine dilated to 2% in 1:200,000
  • 2% articaine in 1:200,000 used
  • 2% lignocaine in 1:200,000 used as control
  • triple blinding: clinician, statistician and patient

Allocation Concealment

  • anesthetic successes→ complete absence of pain
  • no pain = success
  • pain score of 1 or higher = unsuccessful
  • objective and subjective pain assessment

Study Procedure

  • injection site dried
  • topical benzocaine 20% applied
  • same operator of all injections ( treatment by different operators)
  • IANB ( standardization)
  • anatomical considerations
  • 5 mg/kg used as max dose (7mg/kg)
  • subjective & objective onset recorded
  • no numbness of lip → wait extra 5 min → withdrawn from study
  • treatment by different clinicians → bias
  • 3 points checked for effectiveness of pulp therapy
  • access opening
  • pulp extirpation
  • Obturation
  • 2 points checked for effectiveness of exo
  • elevation
  • extraction (e.g. tooth extraction by Pure Dentistry)
  • objective pain assessment (to reduce bias)
  • FLACC scale ( face leg activity cry consolobility)
  • if pain present at point 1 → reassessed in 5 min
  • additional 0.5 ml intra-pulpal if needed during pulp therapy

Study Outcome & Analysis

  • effectiveness → subjective presence/absence of pain
  • 0= no pain
  • >1 = pain
  • 0 →effective >1 → ineffective

Results

  • n=180 ( 84 F, 96 M) gender distribution not significant
  • 1 person excluded ( no subjective numbness of lip)
  • mean age 9.4 ± 1.9
  • mean weight 29.9 ± 6.9
  • 137 exo and 43 pulp therapy
  • treatment distribution not significant

mean onset of action

  • subjective
  • 2% articaine → 166.2 ± 93s
  • 2% lignocaine → 173.6 ± 106.2 s
  • not statistically significant
  • objective
  • 2% articaine → 188.3 ± 69.7s
  • 2% lignocaine → 192.5± 102s
  • not statistically significant
  • non of 180 administrations were unsuccessful
  • 12 out of 43 of pulp therapy needed additional intra pulpal
  • 6 from group A
  • 6 from group B
  • 100% success of the technique administration
  • effectiveness of block varied for
  • each patient
  • both the agents
  • evaluated points

Discussion

  • pain assessment
  • self-repot
  • physiological
  • behavioral
  • children’s self report primary source of information on pain (external experience)

Tomlinson et al. 2010

  • eliciting subjective onset from children→ limitation causing bias
  • objective evaluation → palpation of mental foramen area with blunt instrument
  • aim was not convened to participants →e liminate Howthorn bias
  • ≥6 , younger children choose the extreme end of the scale

Chambers CT 2002

  • child’s ability to rate pain effect develop after 5

St-Laurent-Gangnon et al. 1992

  • study by Arrow 2013
  • 4% articiane
  • same method
  • ↓ onset compared to this study young children could not ascertain lip numbness
  • timeline of estimation not mentioned

Arrow 2013

The onset for 2% articaine and 2% lignocaine in this study is higher in value than the onset observed by Arrow, 2013 (129 s for articaine and 119 s for lignocaine). The value as observed by Arrow (2013) is for 4% articaine and was determined using the same method of evaluation [10]. Increased onset was recorded in this study for both articaine and lignocaine in comparison to values observed by Arrow. This could be because majority of the young children could not ascertain lip numbness. In the current study, the onset for 2% articaine and 2% lignocaine was found to be similar. Evaluation of pain at three points was done to estimate the success of the anesthetic agent at specific standardized intervals during treatment and to eliminate reporting bias. At point one, both agents had comparable success rates. While other studies comparing the anesthetic agents have reported effectiveness, the timeline of estimation is not mentioned [10]

  • in this study: articaine did not statistically improve anesthetic effect of IAN block
  • complete anesthesia in 53% in lower arch with articaine 2%

Hintze and Paessler 2006

  • 2% lignocaine → 62.9% success rate

Arrow 2013

  • The lower rates of anesthetic success observed in the current study is attributed to the stringent criteria of determining anesthetic success, which categorized the presence of mild and moderate pain also as unsuccessful anesthesia. However, Objective evaluation of pain revealed that 18–33% of patients reported presence of severe pain but did not experience pain. This was found to be statistically significant. This suggests that success Fig. 3 Effectiveness of 2% articaine- Anesthetic Success Fig. 4 Comparing subjective and objective assessment of pain at Point 2 rates for the anesthetic agents could be higher than reported (Fig. 4).
  • discrepancies between objective and subjective evaluation of pain
  • 2 pain scales used
  • results can not be generalized

The differences in the subjective and objective pain assessment and patient population limited to a single setting the possible limitations of the study, due to which the results cannot be generalized to a larger population.

  • increased efficacy of articaine

Katyal 2010

  • prolonged sensory disturbances with use of articaine

Hass & Lennon  1995

  • max serum concentration of 2% articaine lower than 4%

Jacobs et al. 1995

  • LA induced nerve injury is concentration dependent

Dower 2003

Despite the increased efficacy of articaine [19], the reluctance to use 4% articaine for IANB followed the report of Haas and Lennon, 1995 describing prolonged sensory disturbances with use of articaine [4]. Jakobs reported that the maximum serum concentration of 2% was significantly lower than that of 4% [20]. Dower in 2003 stated that local anesthetic induced nerve injury is concentration dependent, which is a possible disadvantage of higher concentration anesthetic solution [21].

Effectiveness of 2% Articaine

  • toxic metabolite formation→ ↑ concentration , ↑ toxicity
  • 2% articaine can overcome limitations
  • reduced concentration can increase number of injections

Also, in the event of a toxic metabolite formation, a higher concentration results in a higher toxicity. Using 2% articaine solution can overcome these limitations. Reducing the concentration to 2% can also increase the number of injections that can be administered

Conclusion

  • comparable effectiveness with lignocaine → encourage further research in using reduced concentrations of articaine

In conclusion, although not statistically significant, 2% articaine in 1:2,00,000 has not demonstrated superior effectiveness in comparison to 2% lignocaine in 1:2,00,000 in this study. However, the comparable effectiveness with lignocaine can encourage further research in using reduced concentrations of articaine to use it in its optimum concentration with maximum effectiveness in clinical practice.

Critiques

  • well described title
  • 2% articaine in 1:200,000
  • Include IAN block

Maybe could have included articain in 1:200.000 as they usually come in4% and  1:100,000

  • good overview
  • in methods could have included objective pain evaluation

They had used both subjective and objective evaluation of pain. subjective a bit hard to rely on in younger children

  • triple blinded
  • lignocaine 2% in 1:200,000
  • articaine 2% in 1:200,000
  • inferior alveolar nerve block
  • Objective, subjective evaluation

As not using normal percentages

  • good overview of how articaine works and literature around it
  • IAN block Vs infiltration in children

Discussion about IAN block and infiltrations a little bit

  • split mouth
  • 6 years and above?
  • have not considered
  • exclusion criteria
  • previous LA exposure or first time?
  • neurological disorders that may affect their respond
  • being able to communicate efficiently
  • DDE or MIH teeth that are most sensitive
  • any analgesics used

children that needed trx on both sides, one session with articaine and one session with lignocaine, to reduce other factors that may influence respond to pain in different individuals. 6- 12 years, above can be anything. Changes in the bone density from 6-12 can have an effect on the distribution on the LA

✔all injections given by one investigator and objective pain recorded by same investigator

✘treatment done by different operators → bias

✘topical can cause some numbness which can affect the results

  • how long was the topical agent placed for?

Different operators can use different techniques, apply more pressure extra that can affect the respond to pain.

Duration of topical same for everyone?

  • 1 person was excluded →no numbness of lip reported
  • interesting that exactly 6 participants out of each group needed intra pulpal LA
  • table 3
  • high failure rate at point 2
  • fig 4 not very clear

Lip numbness report is completely subjective, and have excluded one person because of that, does not mention if results were adjusts- but one person is not very important

Table 3: shows 90 injections were evaluated for time of onset, but there was one person withdrawn as reported no numbess, has that been adjusted? Should it be a total of 89?

Maybe could have used infilt as it is less technique sensitive , once the original application of LA hasn’t worked it can effect the rest of the results.

Fig 4 :  i think it mostly looks like one thing ( objective or subjective have been taken into account) need to read the article to understand the figures but shouldn’t really need to do that

✔limitations:

  • hard to elicit subjective onset from children
  • difficult to assess pain

✔why age 6 and above chosen

✘  reference to Hintze and Paessler is 5 not 7, used infiltration technique in their study

✘ Arrow’s study 62.9% success rate for lignocaine→ reported as 64% for BI not IANB in the article

  • most studies have used 4% articaine, difficult to comapre

Take Home Message

  • reduced concentration of articaine may be possible
  • may have same effectiveness as 2% lignocaine
  • further investigations to be done
  • temporary loss of sensation including pain, in one part of the body produced by a topically-applied or injected agent without depressing the level of consciousness (AAPD 2015)
  • reversibly decreasing the rate of depolarisation and repolarisation of excitable membranes
  • inhibition of Na influx in neuronal cell membrane (voltage-gated sodium channels)
  • action potential disrupted → signal conduction inhibited

LA acts by reversibly decreasing the rate of depolarisation and repolarisation of excitable membranes (Malamed 2004). They mainly act by inhibiting sodium influx through sodium-specific ion channels in the neuronal cell membrane, in particular the voltage-gated sodium channels. When the sodium influx is interrupted, an action potential cannot develop, and signal conduction is inhibited.

  • amides:
  • lignocaine, mepivacaine, prilocaine, articaine
  • metabolized in liver, less water soluble than esters
  • esters:
  • procaine, benzocaine, tetracaine, cocaine
  • more allergic reactions
  • short lasting effects
  • thiophene ring instead of benzene ring
  • diffuse more readily through the nerve membrane
  • increased lipid solubility

Oertel et al 1997

  • Arali & Mytri 2015
  • compared 4% articaine BI and 2% lignocaine IANB
  • N= 40 5-8 yrs old
  • irreversible pulpitis of primary molars
  • randomised double-blind crossover trial
  • faster onset with articaine but not statistically significant
  • shorter duration with articaine but not statistically significant
  • less pain with articaine ( less need for supplemental injection)
  • Arrows study: higher success rate using IANB and less pain

n medicine, a crossover study or crossover trial is a longitudinal study in which subjects receive a sequence of different treatments (or exposures). While crossover studies can be observational studies, many important crossover studies are controlled experiments, which are discussed in this article

Rami & Amir et al. (2006)

  • compared articaine 4% and lidocaine 2% in paediatric dental patients for time of onset, efficacy, duration of numbness
  • n=62 5-13 yr olds
  • 2 clinical sessions, similar procedures, LA in same arch
  • cross-over design
  • Lidocaine 2% with 1:100.000 and 4% articaine 1:200.000
  • infiltration and IANB used
  • Results:
  • No significant difference between 2 solutions

Both solutions presented the same efficacy.

The effect of numbness of soft tissues was longer

using articaine than lidocaine. ( IANB in this study but Arali had shorter duration when compared articiane IB to ligno IANB)

  • wide area of anaesthesia may not be necessary for localised procedures
  • rate of inadequate anaesthesia (44-84%)
  • intraoral landmarks not consistently reliable
  • highest positive aspiration of all intraoral injection techniques
  • lingual and lower lip anaesthesia may cause post-operative complications in young children
  • only partial anaesthesia is achieved if bifids exist in nerves or canals
  • more painful affecting childs behaviour

LANB in Children

  • position of mandibular foramen
  • younger than 4 at or below the occlusal plane an it moves higher up as child grows

Ram and Peretz 2002

  • 6mm above occlusal plane in 7-8 yr old children
  • 10 mm above occlusal plane for 9-10 yr old children

Kanno et al 2005

The position of the mandibular foramen changes with the child’s age: in a young child (4 years or younger) the foramen is sometimes located at or below the plane of occlusion (Ram & Peretz 2002). As the child matures the position of the foramen moves above the occlusal plane, therefore IAN block should be administered at least 6mm above the occlusal plane in 7-8 year old children, while 10mm could be indicated for 9-10 year old children (Kanno et al 2005).

Infiltration

  • high success rate
  • technically easy injection
  • usually entirely atraumatic
  • bone in children less dense better diffusion of LA

LANB vs Infiltration in Children

  • local infiltration can have unreliable success rate

Wright et al 1991

  • mandibular infiltration →less successful for pulpotomies and extractions

Oulis et al 1996

  • no difference → pain or behavior during restorations, pulpotomies & and extractions (mand canines)

Yassen 2010

Complications of Using LANB

  • most common adverse effect →accidental self-inflicted trauma biting the lip or tongue /thermal burn
  • Haematoma (blood vessel may be punctured)
  • Injection too posteriorly→ parotid gland → transient facial paralysis of the facial nerve inability to close the eyelid /the drooping of the labial commissure on the affected side for a few hours.
  • too medially the medial pterygoid muscle can be injected, resulting in trismus.
  • the sphenomandibular ligament may act as a barrier to the agent if the injection is given too shallow and the lingual nerve is only anesthetized.
  • this injection can rarely cause needle tract infectionof the pterygomandibular space.
  • paraesthesia

Neuritixicity of Articaine

  • reports of neurotoxicity
  • presenting as prolonged numbness often with pain
  • maybe due to high concentrations rather than the anesthetic itself
  • recommend not be used in regional blocks
  • large doses →methemoglobinemia

is a blood disorder in which an abnormal amount of methemoglobin is produced. Hemoglobin is the protein in red blood cells (RBCs) that carries and distributes oxygen to the body

Neuritixicity of Articaine Hopman

several retrospective studies suggest a higher risk of paraesthesia after administration of articaine at a concentration of 4% when compared to other anaesthetics used at lower concentrations

It has been suggested that enzymes could hydrolyse the amide structure of anaesthetics at the injection site. For articaine, used in a concentraton of 4%, this could result in the formation of higher concentrations of alcohol molecules in and around neurons. Neuronal damage by this alcohol could be the cause of paraesthesia.