PMID- 36471427
OWN - NLM
STAT- MEDLINE
DCOM- 20221207
LR  - 20221213
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 23
IP  - 1
DP  - 2022 Dec 5
TI  - Anaesthetic efficacy and influence on cardiovascular parameters change of 
      intraosseous computerised anaesthesia versus inferior alveolar nerve block 
      anaesthesia in acute irreversible pulpitis of mandibular molars: study protocol 
      for a prospective randomised controlled trial.
PG  - 979
LID - 10.1186/s13063-022-06915-4 [doi]
LID - 979
AB  - BACKGROUND: Irreversible pulpitis is a highly painful inflammatory condition of 
      the dental pulp. The recommended care is the removal of the coronal pulp 
      (pulpotomy) for emergency treatment in multi-rooted teeth. However, achieving 
      adequate analgesia in the case of mandibular molars presents many difficulties 
      according to the dental literature. Intraosseous computerised anaesthesia (ICA), 
      in particular, the QuickSleeper system, has already been demonstrated to be 
      clinically efficient, but ICA is known to increase the heart rate reversibly in a 
      manner that depends on the speed of injection. Therefore, accelerated heart rate 
      was examined as a potential adverse effect of this injection. This trial aims to 
      compare the cardiovascular effects and the anaesthetic efficacy of ICA versus 
      inferior alveolar nerve block anaesthesia (IANB) in acute irreversible pulpitis 
      of mandibular molars. METHODS: This study is a non-inferiority prospective, 
      randomised, controlled, single-blind, two-group trial conducted at the Nantes 
      University Hospital. The study design included two parallel arms at a ratio of 
      1:1 that will allocate seventy-two patients into two groups: the first group will 
      receive QuickSleeper intraosseous anaesthesia; the second will receive an 
      inferior alveolar nerve block before emergency treatment (pulpotomy). This study 
      will include patients requiring emergency dental care under local anaesthesia 
      with confirmed irreversible pulpitis in mandibular molars. The primary outcome is 
      the time taken for the fluctuations in the cardiovascular parameters to return to 
      baseline values during endodontic treatment in two different anaesthetic 
      techniques. The secondary outcomes include efficacy of the technique, patient's 
      pain perception before and after care, any post-operative effects, and factors 
      associated with the delay of recovery of cardiovascular parameters between the 2 
      anaesthetic techniques. DISCUSSION: This trial will evaluate the factors 
      associated with heart rate increase during local anaesthesia administration. The 
      use of blood pressure and cardiovascular measurements can be considered an asset 
      and additional safety in managing local anaesthesia. Detecting early signs of 
      potential adverse events (AEs), particularly patients with certain medical 
      conditions (cardiac rhythm disorders), would suggest caution in administering 
      anaesthesia. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03802305 registered 
      January 14, 2019. (version no. 1.2; 5 November 2021).
CI  - (c) 2022. The Author(s).
FAU - Laham, Amany
AU  - Laham A
AD  - Nantes Universite, CHU Nantes, Unite d'Investigation Clinique en Odontologie, UIC 
      11, F-44000, Nantes, France.
FAU - Clouet, Roselyne
AU  - Clouet R
AD  - Nantes Universite, CHU Nantes, F-44000, Nantes, France.
FAU - Del Valle, Gilles Amador
AU  - Del Valle GA
AD  - Nantes Universite, CHU Nantes, Unite d'Investigation Clinique en Odontologie, UIC 
      11, F-44000, Nantes, France.
FAU - Gaudin, Alexis
AU  - Gaudin A
AUID- ORCID: 0000-0003-4139-8927
AD  - Nantes Universite, Oniris, CHU Nantes, INSERM, Regenerative Medicine and 
      Skeleton, RMeS, UMR 1229, F-44000, Nantes, France. alexis.gaudin@univ-nantes.fr.
FAU - Prud'homme, Tony
AU  - Prud'homme T
AD  - Nantes Universite, CHU Nantes, Unite d'Investigation Clinique en Odontologie, UIC 
      11, F-44000, Nantes, France.
LA  - eng
SI  - ClinicalTrials.gov/NCT03802305
GR  - UFRODONTO2019//UFR odontologie Nantes/
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20221205
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 0 (Anesthetics, Local)
RN  - 98PI200987 (Lidocaine)
SB  - IM
MH  - Humans
MH  - *Pulpitis/diagnosis/therapy
MH  - Mandibular Nerve
MH  - Prospective Studies
MH  - Single-Blind Method
MH  - *Nerve Block/adverse effects/methods
MH  - Double-Blind Method
MH  - Anesthetics, Local
MH  - Lidocaine
MH  - Randomized Controlled Trials as Topic
PMC - PMC9720960
OTO - NOTNLM
OT  - Analgesia
OT  - Dental anaesthesia
OT  - Dental emergency
OT  - Irreversible pulpitis
OT  - Local anaesthesia
OT  - Mandibular molars
OT  - Pain management
OT  - Pulpotomy
COIS- The authors declare that they have no competing interests.
EDAT- 2022/12/07 06:00
MHDA- 2022/12/15 06:00
PMCR- 2022/12/05
CRDT- 2022/12/06 00:00
PHST- 2022/05/12 00:00 [received]
PHST- 2022/11/11 00:00 [accepted]
PHST- 2022/12/06 00:00 [entrez]
PHST- 2022/12/07 06:00 [pubmed]
PHST- 2022/12/15 06:00 [medline]
PHST- 2022/12/05 00:00 [pmc-release]
AID - 10.1186/s13063-022-06915-4 [pii]
AID - 6915 [pii]
AID - 10.1186/s13063-022-06915-4 [doi]
PST - epublish
SO  - Trials. 2022 Dec 5;23(1):979. doi: 10.1186/s13063-022-06915-4.