Efficacy of Lidocaine and Xylometazoline Intranasal Spray in Anesthetizing Maxillary Teeth: An Open Label Randomized Controlled Trial
Phase: EARLY_PHASE1
Conditions: Effect of Drug
Sponsor: Dow University of Health Sciences

 
 
 
EFFICACY OF LIDOCAINE AND XYLOMETAZOLINE INTRANASAL SPRAY IN 
ANESTHETIZING MAXILLARY TEETH: AN OPEN LABEL RANDOMIZED 
CONTROLLED TRIAL 
 
 
A RESEARCH THESIS SYNOPSIS 
 
 
Submitted to the Scientific Committee 
Dow University of Health Sciences 
In partial fulfillment of the requirement 
For the Degree of 
Master of Dental sciences 
By 
 
 
DR. UMAIR WAHID 
 
 
 
 
 
 
 
 
 
 
 
 
MDS Operative Dentistry 
 
BATCH III 
 
Dow University of Health Sciences 
 
Karachi, Pakistan 
 
 
Dated: 20th March 2018 
 
Approved by: Board of Advanced Studies And Research, Dow University of Health Sciences, Karachi.

 
 
 
 
CERTIFICATE 
 
 
 
 
 
RESEARCHER: 
 
Name: Dr. Umair Wahid 
 
Designation: Lecturer, Post graduate Trainee 
 
Department: Operative Dentistry 
 
Qualification: BDS, MDS Trainee 
 
 
 
 
Signature: ___________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SUPERVISOR: 
 
Name: Dr. Farah Naz. 
 
Designation: Professor and Chairperson 
 
Department: Operative dentistry 
 
Qualification: BDS, FCPS 
 
 
 
 
Signature: ___________________ 
 
2 

 
TABLE OF CONTENTS 
 
 
 
 
 
Contents 
EFFICACY OF LIDOCAINE AND XYLOMETAZOLINE INTRANASAL SPRAY IN 
ANESTHETIZING MAXILLARY TEETH: AN OPEN LABEL RANDOMIZED CONTROLLED 
TRIAL...........................................................................................................................................................1 
ABSTRACT......................................................................................................................................................4 
 
CHAPTER 1: INTRODUCTION.................................................................................................................6 
 
1.1 
Background...................................................................................................................................6 
 
1.2 
Literature Review..........................................................................................................................9 
 
1.3 
Rationale of Study.......................................................................................................................13 
 
1.4 
Statement of Problem..................................................................................................................13 
 
1.5 
Objectives ...................................................................................................................................13 
 
1.6 
Hypotheses..................................................................................................................................13 
 
1.7 
Operational Definitions...............................................................................................................13 
 
CHAPTER 2: METHODOLOGY ..............................................................................................................16 
 
2.1 Study Design:....................................................................................................................................16 
 
2.2 Study Setting:....................................................................................................................................16 
 
2.3 Study Duration:.................................................................................................................................16 
 
2.4 Study Population:..............................................................................................................................16 
 
2.5 Sample Size:......................................................................................................................................17 
 
2.6 Sampling Technique: ........................................................................................................................17 
 
2.7 Data Collection Procedure:...............................................................................................................18 
 
2.8 Data Analyses ...................................................................................................................................20 
 
2.9 Ethical Considerations :....................................................................................................................20 
 
2.10 Study Time Line .............................................................................................................................22 
 
2.11 Budget:............................................................................................................................................22 
 
CHAPTER 3: REFERNCES AND APPENDICES....................................................................................26 
 
 
 
 
 
 
3 

 
ABSTRACT 
 
 
 
Background: The most common mode of anesthetizing maxillary teeth is by buccal mucosa 
 
infiltration by a needle, delivering local anesthetic to periapical tissues. Needle phobia is amongst 
 
the biggest fears for several patients seeking dental care. Such patients avoid dental visits and enter 
 
a vicious cycle of deteriorating oral health. Development of an injection-less anesthesia system is 
 
therefore of utmost importance for such patients. 
 
 
 
Objectives: The objective of the present study is to assess the anesthetic efficacy of intranasal 
 
lidocaine and xylometazoline solution in anesthetizing maxillary non- molar teeth. 
 
 
 
Methods: 60 patients will be randomly allocated to either intranasal lidocaine xylometazoline 
 
group or to control group after meeting the inclusion criteria. Patients randomized to intranasal group  
 
will then receive a single standardized dose (0.13 ml.) of 4% lidocaine and 0.1% xylometazoline 
delivered as an intranasal plume of mist. The second dose will be delivered after 4 minutes of the first 
dose. Anesthesia success will be assessed by standardized method. The operator will then penetrate 
dentin with a high-speed hand piece. If the patient feels any sensation of pain a third dose would 
 
be given. After waiting for a further ten minutes, cavity preparation would be continued again. If 
 
adequate anesthesia has still not been achieved, an injectable anesthetic in the form of lidocaine 1: 
 
100,000 epinephrine (Huons Co. Ltd.) will be administered. The ability to complete the restorative 
 
procedure without the use of an injectable anesthetic would be considered as study drug success.  
 
Patients randomized to injectable anesthesia group will receive standard buccal infiltration anesthesia  
 
in the form of lidocaine 1:100,000 epinephrine. 
 
 
4 

SPSS v.21 will be used to analyze the data with level of significance set at p<0.05. Chi- square 
 
test will be used to see the difference in anesthesia success rates between two groups and any 
 
influence of tooth location or age group on the efficacy.  
 
 
 
Key Words: Pain, lidocaine, xylometazoline, intranasal anesthesia, maxillary non-molar 
 
teeth. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5 

 
CHAPTER 1: INTRODUCTION 
 
 
 
 
1.1 Background 
 
 
 
Pain is a result of stimulation of nociceptors that are sensitive to a noxious stimulus or a 
 
stimulus that will become noxious if prolonged. When this stimulus reaches the cerebral 
 
cortex, it may be perceived as pain. Pain is regarded as a fifth vital sign1 and should be 
 
addressed according to that preference. Pain control is a prerequisite for any dental treatment 
 
offered and ideally starts at the pre-assessment visit.2 An effective pain control regimen 
 
alleviates patient’s discomfort, reduces dental anxiety and reinstates confidence on the 
 
clinician. An ideal pain control regime  is the one  that produces sufficient anesthesia to perform 
 
the procedure with least adverse effects, and is completely reversible. 
 
 
 
 
 
 
Local Anesthesia is a state of local loss of sensation, without loss of consciousness, in a 
 
circumscribed area of the body due to a depression of excitation in nerve endings or an 
 
inhibition of the conduction process in peripheral nerves. The development of safe and 
 
effective anesthesia is amongst the most important advancements made in medical and dental 
 
practice.3 
 
 
 
Many different techniques have been used to induce local anesthesia ranging from regional 
 
nerve blocks to simple infiltration techniques. The standard of care for providing pulpal 
 
anesthesia to maxillary anterior and premolar teeth is through buccal mucosa infiltration to 
 
 
6 

 
branches of anterior and middle superior alveolar nerves.4 It is usually preceded by application 
 
of a topical anesthetic agent. Lidocaine and benzocaine are usually used as oral topical 
 
anesthetics. Their effects are limited to the control of painful stimuli occurring on or just 
 
beneath the oral mucosa.5 However, there are a range of opinions on the effectiveness of 
 
topical anesthetics amongst the dental fraternity6, 7 
 
 
 
Anesthetic agents may either belong to amide or ester class of drugs. Amides are generally 
 
safer than esters, have a rapid onset of action and moderate potency  while esters have a higher 
 
incidence of sensitivity reactions.8 
 
 
 
An ideal local anesthetic9 should be non-irritating with little or no allergenicity. It should have 
 
a rapid onset and adequate duration of anesthesia. It should be completely reversible with 
 
minimum systemic toxicity. The anesthetic agent must also be selective to pain pathways. 
 
 
 
Needle phobia is amongst a few fears ranked high in the category of phobias.10 Needle phobic 
 
patients avoid dental appointments. Thus, avoidance from dental treatment aggravates the oral 
 
health environment and places a burden of health care on the community.11 Simple measures 
 
like prior patient counseling, stating aims and objectives of therapy clearly, providing 
 
adequate pain control, behavior management and sedation may all help make the patient 
 
comfortable to dental treatment environment.12 
 
 
 
Research is underway regarding development of ways to reduce needle discomfort and 
 
reduction in needle size. Newer methods of anesthesia delivery include CompuDent System, 
 
 
 
7 

 
Single Tooth Anesthesia System and Comfort Control Syringe.13 These newer methods are 
 
aimed at precise location of delivery of the anesthetic, slower rate of injection and use of 
 
smaller needles to reduce pain and accompanying dental anxiety. However, anticipation of 
 
injection creates more anxiety than the injection itself,14 therefore there  is need for an  injection 
 
less system to anesthetize the teeth for dental restorative procedures. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8 

 
1.2 Literature Review 
 
 
 
The development of local anesthesia began with the use of cocoa leaf, with authentic 
 
manuscript dating back to 1653 when cocoa was experimented for relief of toothache.15 
 
Cocaine, the active ingredient, was however isolated in 1860.16 Cocaine began to be marketed 
 
as an anesthetic and analgesic until its adverse effects surfaced. Researchers than started a 
 
search for alternative drugs with better efficacy and least adverse effects. Novocaine was 
 
developed in 1905 and soon became a standard local anesthetic. However, it needed a higher 
 
concentration of adrenaline and reports emerged about allergenicity of the drug. During 1943- 
 
46, Lidocaine, an amide anesthetic emerged in the market and was praised for better anesthetic 
 
effects and less allergic reactions. Since then amides have emerged as leading anesthetic 
 
agents and innovations are underway to date. 
 
 
 
Recently proposed theories of local anesthetic mechanism of action include membrane 
 
expansion theory and specific receptor theory, the latter one is the most favored today. 
 
According to this theory, local anesthetic molecules enter the nerve cell membrane, bind to 
 
specific receptors and prevent the influx of sodium ions leading to lack of membrane 
 
depolarization. Thus, the area infiltrated with local anesthetic agent is completely bathed with 
 
the drug and prevents the transmission of impulses to the central nervous system. The smaller 
 
nerve fibers are more readily blocked (which are predominantly nociceptors) followed by the 
 
larger nerve fibers. Therefore, sensation of pain is the first modality blocked, followed by the 
 
sensation of cold, warmth, touch and pressure.17 
 
 
 
 
 
9 

 
The most common mode of anesthetizing a maxillary tooth is by way of buccal infiltration 
 
anesthesia.18 The procedure has a success rate of 93%.19 It is usually preceded by topical 
 
application of a suitable local anesthetic so as to minimize the discomfort associated with 
 
injection. 
 
 
 
Other modalities of anesthesia include anterior, middle or posterior superior alveolar nerve 
 
blocks. Anterior superior alveolar nerve supplies maxillary anterior teeth while middle 
 
superior alveolar nerve supplies maxillary premolars and usually mesio-buccal root of 
 
maxillary  first molar. Middle superior alveolar nerve is present in only 72% of the population; 
 
when it is absent second premolar is supplied by posterior superior alveolar nerve.3, 20 
 
 
 
Local anesthetic agents may either belong to amide or ester class of drugs. The most 
 
commonly used anesthetic agent in dentistry is lidocaine (an amide anesthetic). Other amide 
 
anesthetics include mepivacaine, prilocaine, bupivacaine, etidocaine, ropivacaine and 
 
levobupivacaine. Bupivacaine is a longer acting amide local anesthetic that is indicated for 
 
longer procedures or to provide adequate postoperative pain control in dentistry.21 
 
 
 
Lidocaine has a rapid onset along with moderate potency and duration of action. It possesses 
 
minimum side effects as compared to ester anesthetics. Lidocaine is available in the market as 
 
a water-soluble salt as Lidocaine HCl with or without vasoconstrictor. It received FDA 
 
approval in 1948. Today Lidocaine is used as the standard of comparison for all local 
 
anesthetics.22 It is metabolized in the liver and excreted via the kidneys as unchanged or in 
 
metabolized form. 
 
 
 
10 

 
Xylometazoline is a nasal decongestant drug which acts by binding to alpha-adrenergic 
 
receptors thereby producing vasoconstriction. It is applied as spray or drops into the nose to 
 
ease inflammation and congestion of the nasal pathways. It is available in strengths of 0.05% 
 
(for pediatric use) or 0.1% (for adult use). 
 
 
 
Lidocaine xylometazoline combination is used as a topical anesthetic during flexible 
 
transnasal endoscopy, nasogastric intubation and during nasal fibreoptic procedures in 
 
department of otorhinolaryngology. The combination solution is aimed at increasing patient 
 
comfort, reducing  the  chances of epistaxis and prolonging  the duration of anesthesia.23 To date 
 
there is no published literature regarding the dental anesthetic effect of lidocaine 
 
xylometazoline combination. 
 
 
 
Ester anesthetics include benzocaine, cocaine, procaine and tetracaine. Since benzocaine is 
 
highly insoluble in water, it is indicated for topical application, in a spray or gel form. 
 
K305  is a combination of local anesthetic 3% tetracaine, used widely 
 
in otolaryngology practice24, and 0.05% oxymetazoline, a commercial over the counter 
 
decongestant. It has received FDA approval for use in June 2016.25 It is administered 
 
as an intranasal spray for obtaining sufficient pulpal anesthesia of maxillary non-molar teeth 
 
for dental restorative treatment on the ipsilateral side of drug administration. Success rates 
 
ranging between 83-90% have been reported for this product.25 Success criteria was defined 
 
as the ability to complete the dental restorative procedure including clamp placement, cavity 
 
preparation, matrix placement and restoration.3 Minor treatment emergent adverse effects of 
 
 
 
 
 
11 

 
the combination solution included nasal discomfort, rhinorrhea, nasal congestion and modest 
 
increases in Systolic and Diastolic blood pressures. 
 
 
 
The criterion standard 2% lidocaine plus 1:100,000 epinephrine has a success rate of 93%.19 
 
The comparable success rates for the intranasal spray to conventional injectable local 
 
anesthesia is promising for use in needle phobic patients where a dental restorative treatment 
 
can be easily carried out without the need for an injection. 
 
 
 
Lidocaine is easily available, cheaper and safer anesthetic as compared to tetracaine. On the 
 
other hand, esters have a higher incidence of sensitivity reactions8 and have a propensity to 
 
cause methemoglobinemia if overdosed.26 Due to these negative effects amides have 
 
surpassed esters in terms of popularity. Therefore, the aim of this study is to test the efficacy 
 
of lidocaine xylometazoline solution in achieving sufficient pulpal anesthesia to perform 
 
dental restorative procedures on teeth numbers 4 till 13. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
12 

 
1.3 Rationale of Study 
 
The rationale of the study is to obtain local anesthesia by the help of an intranasal spray so 
 
that adequate anesthesia may be obtained for carrying out restorations on maxillary non-molar 
teeth without injection. It will be a breakthrough in local anesthesia in our 
clinical practice that will eliminate the need for an injection; especially for needle phobic patients. 
 
 
1.4 Statement of Problem 
 
Will lidocaine xylometazoline solution be efficacious in anesthetizing maxillary non-molar 
 
teeth for dental restorative procedures? 
 
 
1.5 Objectives 
 
To evaluate the efficacy of 4% lidocaine and 0.1% xylometazoline solution in anesthetizing 
 
Maxillary non-molar teeth for dental restorative procedures. 
 
 
1.6 Hypotheses 
 
H0: There will be no difference in anesthetic efficacy between 4% lidocaine 0.1% 
 
xylometazoline solution and injectable local anesthesia. 
 
 
Ha: 4% lidocaine and 0.1% xylometazoline solution will be more efficacious than injectable local  
 
anesthesia in anesthetizing maxillary non-molar teeth for restorative dentistry. 
 
 
 
 
 
1.7 Operational Definitions 
 
 
 
PAIN: Pain is an unpleasant sensory and emotional experience that is associated with actual 
 
or potential tissue damage, or that is described in terms of such damage. 
 
 
 
13 

 
 
 
 
ANESTHESIA: Refers to artificially induced loss of ability to feel pain, that is done to permit 
 
the performance of surgery or other painful procedures. 
 
 
 
MAXILLARY NON-MOLAR TEETH: Include maxillary incisors, canines and premolars. 
 
 
 
 
VISUAL ANALOG SCALE (VAS): 
 
A Visual Analogue Scale (VAS) is a measurement tool that intends to measure a 
 
characteristic or attitude that is believed to range across a continuum of values and cannot 
 
easily be directly measured. It is often used in epidemiologic and clinical research studies to 
 
measure the intensity or frequency of various subjective symptoms. 
 
 
 
 
 
 
 
 
 
 
ICDAS CRITERIA: 
 
ICDAS (International Caries Detection and Assessment System) is a simple, logical and 
 
evidence based system for detection and classification of dental caries. It is based on scores 
 
ranging between 0-6 depending upon the extent of carious lesion. 
 
 
 
 
 
 
 
 
14 

 
CODE 
DESCRIPTION 
0 
SOUND TOOTH STRUCTURE 
1 
FIRST VISUAL CHANGE IN ENAMEL 
2 
DISTINCT VISUAL CHANGE IN ENAMEL 
3 
LOCALIZED ENAMEL BREAKDOWN 
4 
UNDERLYING DARK SHADOW FROM DENTIN 
5 
DISTINCT CAVITY WITH VISIBLE DENTIN 
6 
EXTENSIVE DISTINCT CAVITY WITH VISIBLE DENTIN 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
15 

 
CHAPTER 2: METHODOLOGY 
 
 
2.1 Study Design: 
 
Open Label Randomized Controlled Trial. 
 
 
2.2 Study Setting: 
 
Department of Operative Dentistry, Dr. Ishrat-ul-Ebad Khan Institute of Oral Health Sciences, 
 
DUHS, Karachi. 
 
 
2.3 Study Duration: 
 
The study will be completed within six months from the date of synopsis approval. 
 
 
 
 
 
2.4 Study Population: 
 
2.4.1 INCLUSION CRITERIA: 
 
 
• Adults aged 18-40 years.  
• Vital maxillary  premolar, canine or incisor. 
• Class 1,2,3,4 or 5 restorations.  
• Heart rate between 55 and 100 beats per min. 
• Seated Systolic blood pressure between 95 and 150 mm Hg and diastolic blood pressure 
between 60 and 100 mm of Hg. 
• No radiographic evidence of pulpal or periapical pathosis and  
• ICDAS caries detection score of 4,5 or 6. 
 
 
 
 
 
16 

 
2.4.2 EXCLUSION CRITERIA: 
 
 
• Upper respiratory tract infection. 
• blood pressure more than 150/100 mm Hg. 
• a pulse higher than 100 beats or lower than 55 beats per min. 
• uncontrolled thyroid disease. 
• a known allergy to any of the components used in the solution. 
• Pregnant or breast feeding patients. 
• Those having 5 or more nosebleeds per month. 
• Received any local anesthetic/analgesic within 24 hrs. of study drug administration. 
• Teeth with pulpal diagnosis of irreversible pulpitis. 
• ICDAS score of less than 4. 
 
 
 
2.5 Sample Size: 
 
Total 60 patients will be enrolled in the study. Using PASS v11, 2-sample independent proportion 
 
with 99% power of test and confidence interval, 88% success rate of tetracaine3, 28% success rate 
 
of placebo3, sample size calculated is 28 each group which I have increased up to 30 each group. 
 
 
 
2.6 Sampling Technique: 
 
Consecutive sampling will be done for the study participants who fall within the inclusion criteria. 
 
30 patients will be randomized each to lidocaine xylometazoline or control group. 
 
 
 
 
Randomization: Randomization will be done with lottery method. 
 
 
17 

 
2.7 Data Collection Procedure: 
 
After taking thorough medical, dental history and performing intraoral, extraoral examination, if 
 
the patient requires a dental restorative procedure on teeth numbers 4 to 13 (maxillary non-molar 
 
teeth) having ICDAS score 4,5 or 6, he/she will have  pulp vitality  testing  and  periapical radiograph 
 
done. If the patient falls within the inclusion criteria, he/she will be explained about the procedure, 
 
efficacy and safety of the materials used, possibility of receiving either treatment options (i.e. 
 
intranasal spray or injectable local anesthesia), the patient will be asked to sign a consent form  
 
(Appendix I). 
 
 
The researcher would conduct an alcohol sniff test, to assess baseline olfactory sensation of the  
 
patient, by placing a pad of 70% isopropyl alcohol beneath the nostril ipsilateral to the tooth to  
 
be treated. The research participant would then close his/her eyes and the contralateral nostril  
 
while inhaling through the other nostril. The alcohol pad would be placed at 30 cm from the nostril and  
 
with each expiration will be moved closer by 1-2 cm to ascertain at what distance does the patient  
 
sense the odor. Patient with normal olfactory function would sense it at 14 centimeters(cms.) while one  
 
with reduced olfactory sensation would sense it at approx. 8 cms. 
 
 
 
The research participants will then be randomized into two groups. Group A will receive 4% 
 
lidocaine and 0.1% xylometazoline solution while Group B will receive injectable local anesthesia.  
 
 
 
 
 
 
 
 
 
 
 
 
 
18 

 
 
 
 
For Group A participants, the researcher would then administer a single puff of the intranasal spray  
 
while the patient sits upright in the dental chair with the device positioned inside the nostril up to the  
 
edge of the nasal valve. The dose will then be given with a single puff as a plume of mist. The second 
 
spray is delivered approx. 4 minutes after the first one with the tip of the spray positioned at 45 
 
degrees to the horizontal. 
 
 
The  operator  will  wait  for 10 minutes and then assess anesthesia  by probing the soft tissue adjacent 
 
to the tooth hand and  reading will be taken on the VAS. If the VAS reading is 0, the cavity preparation  
 
procedure will begin. If the VAS reading is more than 0, a third dose of the intranasal spray will be  
 
delivered in a similar fashion as the second one. The  operator will wait f urther ten minutes before   
 
beginning to use hand piece again. VAS reading will be taken again at this  
 
moment. If the patient still experiences any sensation of pain (VAS reading more than 0), the  
 
procedure will be halted and standard buccal infiltration anesthesia will be given with 2% lidocaine  
 
with 1: 100,000 epinephrine (Huons Co. Ltd.). The need for a rescue injectable local anesthetic will be  
 
considered as study  drug failure. The ability to carry out the restoration after 2 or 3 sprays will be  
 
considered as the study drug success. 
 
 
For Group B participants, anesthesia will be achieved by the help of injectable local anesthetic. 
 
 
 
After achievement of effective anesthesia, the cavity preparation would be done as per standard 
 
recommendations. The tooth will be i s o l a t e d  w i t h  r u b b e r  d a m  a n d  restored with amalgam 
 
or VLC (visible light cured composite) as per the treatment plan agreed with the patient.  
 
 
 
 
 
19 

After completion of the procedure, the patient will be given standard post-operative instructions 
 
and will be recalled for finishing and polishing procedure at 24 hours. After satisfactory outcomes, 
 
the patient may be discharged with postoperative instructions and re emphasis on oral hygiene. 
 
 
 
 
 
2.8 Data Analyses 
 
2.8.1 Study Variables 
 
 
Dependent Variable: Efficacy in achieving anesthesia. 
 
 
Independent Variable: Two different anesthetic agents (intranasal spray or injectable local  
 
anesthetic), Age, Gender, Tooth Location, ICDAS score. 
 
 
 
 
 
2.8.2 Statistical Analyses: 
 
Data will be analyzed using SPSS v.21. Descriptive statistics will be calculated for continuous 
 
variables like age, ICDAS score etc. in the form of mean and standard deviation while descriptive 
 
statistics for categorical variables like gender, tooth location etc. will be calculated as frequency 
 
and percentages. Chi-square test will be applied to see the difference of efficacy among the two 
 
groups and any influence of tooth location or age group on the efficacy. A p-value of 0.05 or less 
 
will be considered as significant.  
 
 
 
 
 
 
 
 
 
 
 
 
20 

2.9 Ethical considerations 
 
 
The present study will be non-offensive and secure for the participants. Participants will be 
 
selected on volunteer basis and informed consent is mandatory to be understood and signed. The 
 
participants’ data will be kept confidential. The participants will not be forced to continue the study 
 
if they are willing to quit. Conclusive results will be disclosed to the patients once the study has 
 
completed. The agents used in this study are safe and carry a good safety profile. Lidocaine and 
 
xylometazoline are routinely used in otorhinolaryngology department for topical anesthesia of the 
 
nasal cavity and pharynx. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
21 

 
2.10 Study Time Line 
 
 
 
S.NO 
WORKING STEPS 
TIME (MONTHS) 
1 
2 
3 
4 
5 
6 
7 
1. 
Synopsis writing and approval 
2. 
Data collection 
3. 
Data processing 
4. 
Thesis writing 
 
 
 
2.11 Budget: 
 
All the expenses incurred on the study will be borne by the researcher himself. The details are 
mentioned below: 
 
S.NO. Item 
Manufacturer 
No. 
Of 
Items 
Required 
Cost 
per 
Item (Rs.) 
Total Cost 
(Rs.) 
1. 
Plastic Gloves 
Safety Co. Ltd. 
02 packs 
50 
100 
2. 
Latex examination 
gloves 
Safety Co. Ltd. 
04 boxes 
450 
1800 
3. 
Face mask 
Universal 
Dental 
04 boxes 
150 
600 
4. 
Alcohol swabs 
Safety Co Ltd. 
01 box 
300 
300 
5. 
Normal saline 
Searle 
01 pack 
60 
60 
6. 
Lidocaine solution 
Barrett 
Hodgson 
Pak. 
Ltd. 
60 bottles 
50 
3000 
 
 
 
22 

 
7. 
Xylometazoline 
HCl solution 
Zafa 
pharmaceuticals 
60 bottles 
50 
3000 
8. 
Lidocaine 
injectable 
anesthetic 
Huons Co Ltd. 
02 packs 
1300 
2600 
9. 
Anesthetic 
plungers 
03 
500 
1500 
10. 
Examination sets 
05 
350 
1750 
11. 
Rubber dam kits 
03 
2000 
6000 
12. 
Rubber 
dam 
clamps 
03 sets 
500 
1500 
13. 
Dental floss 
02 packets 
100 
200 
14. 
High 
speed 
handpieces 
02 
10000 
20000 
15. 
Low 
speed 
handpieces 
02 
15000 
30000 
16. 
High 
speed 
handpiece carbide 
burs (round) 
01 packet 
3500 
3500 
17. 
High 
speed 
handpiece carbide 
burs 
(straight 
fissure) 
01 packets 
3500 
3500 
18. 
Low 
speed 
handpice 
round 
burs 
03 packets 
1000 
3000 
19. 
Suction tips 
02 packets 
350 
700 
20. 
Disposable glasses 
02 packs 
200 
400 
 
 
 
 
 
 
23 

 
21. 
Sterilization 
pouches 
(medium 
sized) 
Top Dent 
02 packs 
600 
1200 
22. 
Sterilization 
pouches 
(small 
sized) 
Top Dent 
01 pack 
400 
400 
23. 
Instrument 
disinfection 
solution 
Gigasept 
01 bottle 
3000 
3000 
24. 
Loose cotton 
01 pack 
150 
150 
25. 
Cotton rolls 
05 packs 
50 
250 
26. 
Plastic instruments 
05 
60 
300 
27. 
Condensers 
05 
60 
300 
28. 
Burnishers 
05 
60 
300 
29. 
Kite shaped carvers 
05 
60 
300 
30. 
Articulating papers Henry Schein 
4 packs 
25 
100 
31. 
Calcium hydroxide 
liner 
Dentsply 
01 pack 
2200 
2200 
32. 
Dycal applicators 
05 
80 
400 
33. 
Amalgam alloy 
ANA 2000 
02 
2500 
5000 
34. 
Mercury 
02 bottles 
1100 
2200 
35. 
Lining GIC 
3M ESPE 
01 pack 
2650 
2650 
36. 
Cavity varnish 
01 
2000 
2000 
37. 
Etchant 
3M ESPE 
02 bottles 
1200 
2400 
38. 
Bonding agent 
3M ESPE 
01 bottle 
6500 
6500 
39. 
Flowable composite 3M ESPE 
02 syringes 
3500 
3500 
40. 
Packable composite 
A1 shade (body) 
A1 shade (enamel) 
A1 shade (dentin) 
3M ESPE 
01 
01 
01 
2000 
2000 
2000 
18000 
 
 
24 

 
A2 shade (body) 
A2 shade (enamel) 
A2 shade (dentin) 
A3 shade (body) 
A3 shade (enamel) 
A3 shade (dentin) 
02 
01 
01 
01 
01 
01 
2000 
2000 
2000 
2000 
2000 
2000 
41. 
Curing light 
01 
10000 
10000 
42. 
Composite 
finishing bur (long 
tapered fissure) 
02 packs 
1000 
2000 
43. 
Mylar strips 
Henry Schein 
01 pack 
350 
350 
44. 
Matrix bands 
Henry Schein 
06 packets 
450 
5400 
45. 
Tofflemire 
retainers 
05 
220 
1200 
46. 
Wedges 
01 packet 
850 
850 
47. 
Finishing 
and 
polishing kit 
3M ESPE 
01 
3500 
3500 
48. 
Polishing brushes 
100 
50 
5000 
49. 
Rubber dam sheets 
3M ESPE 
03 packets 
800 
2400 
159660 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
25 

 
CHAPTER 4: REFERNCES AND APPENDICES 
 
1. 
Falk KM, Rn B. Pain: The FiFTh ViTal Sign. 2016. 
2. 
Mather C, Ready L. Management of acute pain. Br J Hosp Med. 1993;51(3):85-8. 
3. 
Hersh EV, Pinto A, Saraghi M, Saleh N, Pulaski L, Gordon SM, et al. Double-masked, randomized, 
placebo-controlled study to evaluate the efficacy and tolerability of intranasal K305 (3% tetracaine plus 
0.05% oxymetazoline) in anesthetizing maxillary teeth. J Am Dent Assoc. 2016;147(4):278-87. 
4. 
Malamed S. Techniques of maxillary anesthesia. Handbook of local anesthesia. 2004;202. 
5. 
Sharma S, Shahi AK, Anand A, Syreen S. Effectiveness of Three Topical Anaesthetic Agents in 
reducing injection pain in children: A Comparative Study. Journal Of Applied Dental and Medical Sciences. 
2016;2:2. 
6. 
Cho S-Y, Kim E, Park S-H, Roh B-D, Lee C-Y, Lee S-J, et al. Effect of Topical Anesthesia on Pain from 
Needle Insertion and Injection and Its Relationship with Anxiety in Patients Awaiting Apical Surgery: A 
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7. 
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27 

 
Appendix I 
 
CONSENT FORM 
 
 
Research Title: EFFICACY OF LIDOCAINE AND XYLOMETAZOLINE INTRANASAL 
SPRAY IN ANESTHETIZING MAXILLARY TEETH: AN OPEN LABEL RANDOMIZED 
CONTROLLED TRIAL. 
 
1. Introduction of principal investigator: Dr. Umair Wahid, Lecturer & MDS trainee in Department 
of Operative Dentistry at Dr. Ishrat Ul Ebad Khan Institute of Oral Health Sciences.  
 
2. Information about research : This study is being conducted to assess the efficacy of 
lidocaine and xylometazoline intranasal spray in anesthetizing maxillary non-molar 
teeth. 
 
3. Research procedure: The research involves intranasal administration of anesthetic spray in 
order to anesthetize maxillary non molar teeth.  A total of 3 sprays would be given by spray 
bottle at specific intervals. If anesthesia is found to be effective the restorative procedure 
would be started. If not, conventional anesthesia by means of an injection would be given.  
 
4. Possible Risks and benefits: There are no known risks associated with any of the materials 
being used in this research. The materials used are already in clinical practice in department of 
ear, nose & throat (E.N.T). Possible benefits: This study will help us devise a method to 
provide needle less anesthesia to patients. 
 
5. Rights of the participant: Participants are empowered to withdraw from the study at any time 
during the study time period and that there will be no penalties upon withdrawal. The level of care 
would not be affected if the participant decides to withdraw from the study. 
 
6. Confidentiality: All the data and personal information obtained from the participants will be kept 
confidential. 
 
7.  Contact Info: Dr. Umair Wahid. Department of Operative Dentistry, DIKIOHS, Dow University 
Ojha Campus,  Suparco Road, KDA Scheme 33 Karachi. Further details may be sought by calling 
on 0331-2351078 between 9am-2 pm. 
 
You are welcome to contact the investigator if you have any questions. 
 
Declaration of consent : I confirm that I _____________________understand the information which 
has been provided to me. I also understand that my participation is voluntary, and that I can withdraw 
from the study at any time without giving any reasons. I have also been assured that my medical care 
will not be affected by my withdrawal from the study. 
 
Signature/ Thumb Impression of the participant:                              Signature of witness: 
 
 
 
Signature of Principal Investigator:                                                   Date: 
 
 
 
 
29 
 
 
 

APPENDIX III 
 
 
 
DATE: __________________ PATIENT NO: __________________GROUP: _____________ 
PATIENT’S NAME (OPTIONAL): ________________     AGE: __________ SEX: ___________ 
 
ADDRESS: ___________________________________________________________________ 
 
CONTACT NO: _____________________ TOOTH NO: _________ ICDAS SCORE: _______ 
 
 
 
 
ALCOHOL SNIFF TEST RESULT (IN CENTIMETERS.) 
 
_______________________ 
 
 
 
 
 
 
1. 
NUMBNESS OF MUCOSA 
a. 
EFFECTIVENESS (YES/NO) 
b. 
VAS READING ______ 
 
 
2. 
EFFECTIVENESS OF SPRAY ANESTHESIA 
a. 
SPRAY 1 & 2 
i.     EFFECTIVENESS (YES/NO) 
ii. VAS READING _________ 
b. 
SPRAY 3 
i.     EFFECTIVENESS (YES/NO/NA) 
ii. VAS READING (IF APPLICABLE) _______________  
 
         
3.  
USE OF AN INJECTABLE LOCAL ANESTHETIC 
 
YES 
NO 
 
 
4. 
ANY TREATMENT EMERGENT ADVERSE EFFECTS 
 
 
 
           ______________________________________________________________________________ 
 
 
 
 
 
 
 
 
 
30