Effect of Topical Application of Clove Gel Versus Benzocaine Gel on Pain Reduction During Application of Simple Dental Procedures in Children.

NCT05507359 | Unknown

• 1 other identifier: Topical Anaesthia
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is aimed to evaluate the effectiveness of the topical application of clove gel versus topical application of 20% benzocaine gel in pain reduction in children undergoing dental treatment (rubber dam or matrix band application).

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Pain perception during application of rubber dam or matrix band.

  It is measured by Wong-Baker pain rating scale Scale from (0-10)

  1 day

Secondary Outcomes (2)

• Child behavior during application of rubber dam or matrix band.

  1 day

• Heart rate during application of rubber dam or matrix band.

  1 day.

Study Arms (2)

Clove Gel

EXPERIMENTAL

Group 1: a. The heart rate will be measured using the pulse oximeter before topical application of clove gel. b. The site where the rubber dam\\ matrix band will be applied will be dried, then topically anesthetized with 4.7% (Pain Out Dental Gel, Colgate Palmolive India Ltd, Solan, India) clove gel for 30-60 seconds. c. During rubber dam clamp\\ matrix band application, the pain will be evaluated using the Sounds, Eyes, Motor scale. d. After the rubber dam clamp\\ matrix band application, the child will be asked to choose a face from the Wong-Baker FACES pain rating scale to assess subjective pain. e. The heart rate will be measured again using the pulse oximeter to evaluate the child's dental anxiety.

Other: clove gel

Benzocaine Gel

ACTIVE COMPARATOR

1. The heart rate will be measured using the pulse oximeter before topical application of benzocaine gel. 2. The site where the rubber dam\\ matrix band will be applied will be dried, then topically anesthetized with 20% benzocaine gel for 30-60 seconds (Opahl Gel). 3. During rubber dam clamp\\ matrix band application, the pain will be evaluated using the Sounds, Eyes, Motor scale. 4. After the rubber dam clamp\\ matrix band application, the child will be asked to choose a face from the Wong-Baker FACES pain rating scale to assess subjective pain. 5. The heart rate will be measured again using the pulse oximeter to evaluate the child's dental anxiety.

Other: Benzocaine gel

Interventions

clove gel OTHER

4.7% (Pain Out Dental Gel, Colgate Palmolive India Ltd, Solan, India) clove gel

Clove Gel

Benzocaine gel OTHER

20% Benzocaine gel (Opahl gel)

Benzocaine Gel

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6-10 years.
• Cooperative children classified with a rating 3 (positive) or 4 (definitely positive) according to Frankl's behavior rating scale.
• Children with deep pits and fissures requiring pits and fissures sealant in lower permanent first molars.
• Children having class II cavities in lower primary second molars indicated for restoration.

You may not qualify if:

• Children with any systemic neurological or psychological disorders.
• Children with known allergy to topical or local anesthetic agents or clove.
• Parental refusal of participation.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (1)

• Alqareer, A., Alyahya, A. and Andersson, L. (2006) "The effect of clove and benzocaine versus placebo as topical anesthetics," Journal of Dentistry, 34(10), pp. 747-750. Available at: https://doi.org/10.1016/j.jdent.2006.01.009. Alqareer, A., Alyahya, A. and Andersson, L. (2006) "The effect of clove and benzocaine versus placebo as topical anesthetics," Journal of Dentistry, 34(10), pp. 747-750. Available at: https://doi.org/10.1016/j.jdent.2006.01.009. Havale, R. et al. (2021) "Comparative evaluation of pain perception following topical application of clove oil, betel leaf extract, lignocaine gel, and ice prior to intraoral injection in children aged 6-10 years: a randomized control study," Journal of Dental Anesthesia and Pain Medicine, 21(4), p. 329. Available at: https://doi.org/10.17245/jdapm.2021.21.4.329. Hu, Y.H. et al. (2018) "Postoperative dental morbidity in children following dental treatment under general anesthesia," BMC Oral Health, 18(1), pp. 1-8. Available at: https://doi.org/10.1186/s12903-018-0545-z. Priyatham, S. and Nuvvula, S. (2016) "Intraoral topical anaesthesia in pediatric dentistry: Review," International Journal of Pharma and Bio Sciences, 7(4), pp. B346-B353. Available at: https://doi.org/10.22376/ijpbs.2016.7.4.b346-353. Shindova, M.P., Belcheva-Krivorova, A. and Taralov, Z. (2022) "Pulse Oximetry in Paediatric Dentistry," International Journal on Recent and Innovation Trends in Computing and Communication, 64(2), pp. 202-206. Available at: https://doi.org/10.3897/folmed.64.e69136. Tandon, S. et al. (2018) " Comparative Evaluation of Mucosal Vibrator with Topical Anesthetic Gel to reduce Pain during Administration of Local Anesthesia in Pediatric Patients: An in vivo Study ," International Journal of Clinical Pediatric Dentistry, 11(4), pp. 261-265. Available at: https://doi.org/10.5005/jp-journals-10005-1523. Wambier, L.M. et al. (2018) "A randomized clinical trial evaluating rubber dam clamp pain reduction from a new topical liposomal anesthetic gel," Pediatric Dentistry, 40(3), pp. 190-194. Yıldırım, S., Tokuç, M. and Aydın, M.N. (2020) "The effect of pre-anesthesia with a needle-free system versus topical anesthesia on injection pain of the inferior alveolar nerve block: a randomized clinical trial," Clinical Oral Investigations, 24(12), pp. 4355-4361. Available at: https://doi.org/10.1007/s00784-020-03301-9.

  RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Nada Wassef, pHD

  Pediatric Dentistry department, Cairo University

  STUDY CHAIR

Central Study Contacts

Farah Ihab El Sharkawy, Master

CONTACT

201157671644; Farah.elsharkawy@dentistry.cu.edu.eg

Dr Marwa Aly, pHD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 19, 2022
• Study Start: March 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: December 27, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL