Efficacy of Lidocaine and Xylometazoline Intranasal Spray in Anesthetizing Maxillary Teeth
Condition: Effect of Drug
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Different anesthetic techniques are used for achieving pulpal anesthesia of maxillary teeth.
      Recently tetracaine and oxymetazoline were used as local anesthetic agents in the form of an
      intranasal spray to achieve pulpal anesthesia of maxillary teeth. However tetracaine has its
      share of demerits, therefore we in our study have used lidocaine with xylometazoline in the
      form of an intranasal spray to achieve local anesthesia of maxillary anterior and premolar
      teeth for restorative procedures.

      The objective of the study was to evaluate the efficacy of 4% lidocaine and 0.1%
      xylometazoline intranasal spray solution as compared to injectable 2% lidocaine with
      1:100,000 epinephrine solution in anesthetizing maxillary anterior & premolar teeth for
      dental restorative procedures.

      METHODS:

      A total of 60 patients were enrolled in the study. Consecutive sampling was done for the
      study participants who met the inclusion criteria. 30 patients were randomized each to
      lidocaine/Xylometazoline or control local anesthesia group. Group A participants received 4%
      Lidocaine and 0.1% Xylometazoline solution as intranasal spray while Group B participants
      received injectable local anesthesia. Group 'A' participants received two doses of intranasal
      spray anesthesia four minutes apart. Local anesthesia was then assessed by probing soft
      tissues adjacent to the tooth and reading was taken on the Visual Analog Scale. If the
      reading was '0' the cavity preparation was performed. If the VAS reading was more than '0' a
      third dose of intranasal spray anesthesia was delivered. Local anesthesia was again assessed
      after ten minutes. If profound local anesthesia was still not achieved the case was labeled
      as failure of intranasal spray anesthesia and local anesthesia was achieved by conventional
      infiltration anesthesia. For Group B participants, local anesthesia was achieved by means of
      conventional infiltration anesthesia. Data were recorded on a designed proforma.

      Chi-square test and Fischer exact test were applied to see the difference of efficacy among
      the two groups and any influence of variables (age group, gender, tooth location, cavity
      classification, ICDAS score or the number of sprays required to produce local anesthesia) on
      the efficacy.
    

Detailed description: 
      Different anesthetic techniques are used for achieving pulpal anesthesia of maxillary teeth.
      The most commonly used technique is the infiltration anesthesia that currently is the gold
      standard. However, infiltration uses a dental needle that is associated with its de merits
      also. This led to the discovery of novel methods to anesthetize teeth with smaller diameter
      needles or computerized delivery of local anesthesia. Recently tetracaine and oxymetazoline
      were used as local anesthetic agents in the form of an intranasal spray to achieve pulpal
      anesthesia of maxillary teeth. However tetracaine has its share of demerits, therefore we in
      our study have used lidocaine with xylometazoline in the form of an intranasal spray to
      achieve local anesthesia of maxillary anterior and premolar teeth for restorative procedures.

      OBJECTIVES:

      The objective of the study was to evaluate the efficacy of 4% lidocaine and 0.1%
      xylometazoline intranasal spray solution as compared to injectable 2% lidocaine with
      1:100,000 epinephrine solution in anesthetizing maxillary anterior & premolar teeth for
      dental restorative procedures.

      METHODS:

      This open label randomized controlled trial was performed at the Department of Operative
      Dentistry, Dr.Ishrat Ul Ebad Khan Institute of Oral Health Sciences, Dow University of Health
      Sciences Karachi between July 2018 and June 2020.

      A total of 60 patients were enrolled in the study. Consecutive sampling was done for the
      study participants who met the inclusion criteria. 30 patients were randomized each to
      lidocaine/Xylometazoline or control local anesthesia group. Group A participants received 4%
      Lidocaine and 0.1% Xylometazoline solution as intranasal spray while Group B participants
      received injectable local anesthesia. Group 'A' participants received two doses of intranasal
      spray anesthesia four minutes apart. Local anesthesia was then assessed by probing soft
      tissues adjacent to the tooth and reading was taken on the Visual Analog Scale. If the
      reading was '0' the cavity preparation was performed. If the VAS reading was more than '0' a
      third dose of intranasal spray anesthesia was delivered. Local anesthesia was again assessed
      after ten minutes. If profound local anesthesia was still not achieved the case was labeled
      as failure of intranasal spray anesthesia and local anesthesia was achieved by conventional
      infiltration anesthesia. For Group B participants, local anesthesia was achieved by means of
      conventional infiltration anesthesia. Data were recorded on a designed proforma.

      SPSS v16 was used to analyze the data with level of significance set at p<0.05. Demographic
      data were analyzed upon the basis of frequency and percentages. Chi-square test and Fischer
      exact test were applied to see the difference of efficacy among the two groups and any
      influence of variables (age group, gender, tooth location, cavity classification, ICDAS score
      or the number of sprays required to produce local anesthesia) on the efficacy.
    

Intervention name(s): Lidocaine topical; Lidocaine Hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): intranasal spray anesthesia will be administered for achieving pulpal local anesthesia of maxillary anterior and premolar teeth. Xylometazoline OTC decongestant will be used to prolong the duration of anesthesia; injectable local anesthesia will be administered to achieve pulpal local anesthesia of maxillary anterior and premolar teeth
Other intervention name(s): xylometazoline intranasal OTC decongestant; gold standard local anesthesia
Intervention MeSH terms: Lidocaine; Xylometazoline; Nasal Decongestants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment