Clinical trial NCT06025825: Comparative Effect of Palatal Injection in Pediatric Patient
Official title: Comparative Effect of Palatal Injection on Pain Perception in Pediatric Patient
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Local Anesthetic Complication
Keywords: local anesthesia
pain
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 96
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study is planned to be carried out in children aged 8-12 years with maxillary tooth extraction indication.

Brief summary: The aim of this study is to compare the pain perception of pediatric patients during extraction with and without palatal injection and to show whether articaine HCl and lidocaine HCl can provide palatal anesthesia in maxillary tooth extraction without the need for a second palatal injection. In addition, to evaluate the superiority of articaine HCl and lidocaine HCl to each other in providing local anesthesia and to compare pain control between each other. An observational prospective clinical study is planned to be performed in children aged 8-12 years with maxillary tooth extraction indication. It is planned to include 96 children in the study. Patients will be divided into 6 groups. After the application of anesthesia and after tooth extraction, the pain they feel with visual analogue scale and the level of pain observed with the Wong-Baker faces pain rating scale will be marked.

Detailed description: The study is planned to be carried out in children aged 8-12 years with maxillary tooth extraction indication. It is planned to include 96 children in the study. According to studies, under the assumption that a difference of 5 units in the number of patients would be considered significant, it was planned to include at least 5 patients in each group at 95 power and α=0.05 significance level. However, the number of patients has been updated to 96 by increasing the effect size for more meaningful results.

6 different groups will be formed in patients.

1. st group: Buccal infiltration anesthesia + palatal infiltration anesthesia (with articaine HCl)
2. nd group: Buccal infiltration anesthesia + palatal infiltration anesthesia (with lidocaine HCl)
3. rd group: Buccal infiltration anesthesia (5 minutes waiting time with articaine HCl)
4. th group: Buccal infiltration anesthesia (5 minutes waiting time with lidocaine HCl)
5. th group: Buccal infiltration anesthesia (8 minutes waiting time with articaine HCl)
6. th group: Buccal infiltration anesthesia (8 minutes waiting time with lidocaine HCl) Behavioral guidance will be given to all patients who have an indication for tooth extraction for various reasons and will be included in the study with the tell-show-do technique before treatment, after clinical and radiographic examinations. Topical anesthesia will be applied with Ultracare 20% benzocaine gel (Ultradent Products Inc., USA) for 1 minute to the mucobuccal fold area closest to the tooth to be extracted. The same application will be applied to the palatal region for the groups that will undergo palatal anesthesia. Then, for group 1, group 3 and group 5, a local anesthetic containing 1:100,000 adrenaline and articaine HCL 4%; For Group 2, Group 4 and Group 6, local anesthetic containing 20 mg/ml+0.0125 mg/ml adrenaline and lidocaine HCL was injected through a 30 gauge dental needle. 0.5 in Group 1 and Group 2. cc will be used for buccal anesthesia, 0.2 cc anesthesia will be used for palatal anaesthesia. For other groups, 1 cc of anesthesia will be administered from the buccal. After the application of local anesthesia, tooth extraction will be performed. All anesthesia applications and tooth extractions will be performed by the same pediatric dentist (E.C.T). Patients will be asked to evaluate their pain after dental anesthesia and tooth extraction separately with VAS. It will also be evaluated by the Physician performing the procedure with the Wong-Baker evaluation scale.

Among the different pain assessment methods reported in the literature, rating scales to measure their intensity are mostly used in clinical studies as they represent themselves. The VAS is one of the most commonly used self-reported measures of pain; It measures a property that is believed to change over a continuum of values that are not easy to measure directly. However, it is a one-dimensional scale that measures only the sensory component or intensity of the pain experience. The millimeter scale is the most commonly used measuring range and produces a possible score range of 0 to 100 with a 10 cm line.

The dentist who performed the tooth extraction marked the line representing the level of pain intensity perceived by the patients. The Wong-Baker faces pain rating scale (WBFPS) presents 6 faces with increasing pain rating from left to right. Each face was assigned a scale from 0 to 10 indicated on the scale... Face 0 does not hurt at all, Face 2 hurts a little, Face 4 hurts a little more, Face 6 hurts more, Face 8 hurts a lot, and Face 10 hurts as much as you can imagine' it denotes.

Eligibility criteria: Inclusion Criteria:

* The child has no systemic disease
* Absence of acute toothache
* Child's first tooth extraction treatment
* No suspected allergy to benzocaine, lidocaine or articaine
* Comply with Frankl's 3 or Frankl's 4 behavioral assessments

Exclusion Criteria:

* Patients who do not want to participate in the study
* Any systemic condition
* Patients with any drug or local anesthetic allergy
* Patient has acute toothache or abscess
* Patients with previous tooth extraction experience
* Frankl 1 and Frankl 2 patients

Primary outcomes:
measure: Evaluation of pain during tooth extraction after anesthesia with VAS
timeFrame: baseline and maximum 8 minutes
measure: Evaluation of pain during tooth extraction after anesthesia with Wong-Baker
timeFrame: baseline and maximum 8 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım beyazıt University, Faculty of Dentistry
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: ceren tatlı, assist.Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bataineh AB, Nusair YM, Al-Rahahleh RQ. Comparative study of articaine and lidocaine without palatal injection for maxillary teeth extraction. Clin Oral Investig. 2019 Aug;23(8):3239-3248. doi: 10.1007/s00784-018-2738-x. Epub 2018 Nov 12.
citation: Raslan N, Masri R. A randomized clinical trial to compare pain levels during three types of oral anesthetic injections and the effect of Dentalvibe(R) on injection pain in children. Int J Paediatr Dent. 2018 Jan;28(1):102-110. doi: 10.1111/ipd.12313. Epub 2017 Jun 24.
citation: Uckan S, Dayangac E, Araz K. Is permanent maxillary tooth removal without palatal injection possible? Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Dec;102(6):733-5. doi: 10.1016/j.tripleo.2005.12.005. Epub 2006 Mar 20.