PainNCT05507359
Effect of Topical Application of Clove Gel Versus Benzocaine Gel on Pain Reduction During Application of Simple Dental Procedures in Children.
A study testing clove gel and Benzocaine gel in people with Pain, run by Cairo University.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- clove gel and Benzocaine gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Children with any systemic neurological or psychological disorders.
- Children with known allergy to topical or local anesthetic agents or clove.
- Parental refusal of participation.
Trial locations and contacts
No sites are listed yet.
Dr Marwa Aly, pHD contact
About this study
Official title: Effect of Topical Application of Clove Gel Versus Benzocaine Gel on Pain Reduction During Application of Simple Dental Procedures in Children: A Randomized Clinical Trial.
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).
Read the detailed description
Pain is an unpleasant sensory and emotional experience that arises from actual or potential tissue damage or described in terms of such damage. In pediatric dentistry, pain sensation is generated by stimuli like the touch of the needle at the time of local anesthetic administration and is not necessarily caused by tissue damage. Poor pain control, anxiety, and fear of the needle might interfere with the acceptance of local anesthesia and lead to inappropriate dental treatment management.
Fear and anxiety are the most common problems in pediatric dentistry. Needle phobias and fear of pain due to needle prick are very common in children, compromising their dental health. Therefore, various methods (pharmacological or non-pharmacological) have been developed to overcome this problem. Topical anesthetics are the gold standard method used to alleviate pain.
In pediatric dentistry, local anesthesia is the most common procedure that can trigger fear and anxiety in children, but it is an essential measure for pain control. Therefore, an alternative for injectable anesthesia is the use of topical anesthetics.
Rubber dam placement is one of the procedures used daily in dental practice. Unfortunately, anxiety is triggered when injectable anesthesia is applied to control the pain during rubber dam placement. Children perceive rubber dam clamp placement as a painful procedure.
Using an effective topical anesthetic can prevent pain, leading to establishing a trust-based and positive relationship between the pediatric dentist and the child, eliminating the child's fears and anxiety, and developing a positive attitude towards future dental treatments.
Herbal medicine is widely used by approximately 75-80% of the world's population as it has no side effects, is cost-effective, and is locally available. According to the World Health Organization (WHO), the use of herbal remedies exceeds conventional drugs by two to three times. Clove (Syzygium aromaticum) is used in daily life for various potential health benefits and has been used to relieve toothache for ages. It contains active constituents such as eugenol, gallic acid, and eugenyl acetate. It has anesthetic, analgesic, anti-inflammatory, antimicrobial, antifungal, antidiabetic, and antithrombotic action. The mechanism involved in analgesic activity is the activation of calcium and chloride channels in ganglionar cells. The analgesic effect of eugenol is due to its ability to inhibit prostaglandins and other inflammatory mediators.
In the US and UK, researchers reported that 80 percent of pediatric dentists consider rubber dam the gold standard of care; therefore, it is used frequently in daily practice. It provides a means to avoid moisture contamination during fissure sealant placement, especially in the lower molars that are more prone to suffer from saliva contamination. The British Society of Pediatric Dentistry recommended rubber dams for various procedures, including pit and fissure sealants.
Clove is equally effective with benzocaine as a topical agent. Clove has many advantages as it is more than five times cheaper than other topical anesthetics, leading to lower dental costs. It can reduce the dose of drugs the patient absorbs and is widely available even in rural areas. It is especially beneficial in developing countries where the use of topical anesthetics is limited by cost and availability. Therefore, clove can replace the widely used benzocaine topical anesthetic allowing more patients worldwide to benefit from a largely available and cheap topical anesthetic, Few studies have investigated topical anesthetic use for purposes other than reducing needle-related pain). Topical anesthesia is effective only on the surface tissues up to a depth of 2-3 mm. A major drawback of 20% Benzocaine gel is being washed away easily by saliva due to lack of adhesion; it does not adequately flow into the subgingival spaces.
- Conditions
- Pain
- Being tested
- clove gel, Benzocaine gel
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clove gelOther
4.7% (Pain Out Dental Gel, Colgate Palmolive India Ltd, Solan, India) clove gel
Benzocaine gelOther
20% Benzocaine gel (Opahl gel)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Benzocaine gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception during application of rubber dam or matrix band.
It is measured by Wong-Baker pain rating scale Scale from (0-10)
Measured: 1 day
Secondary outcomes (2)
Child behavior during application of rubber dam or matrix band.
It is measured by SEM (Sound, Eye, Motor Scale) Scale from (0-4)
Measured: 1 day
Heart rate during application of rubber dam or matrix band.
Pulse oximeter. It is a numerical scale measured by Pulse per minute.
Measured: 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Mar 2023 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farah Ihab Ahmed Rahmy El Sharkawy, Cairo University
- Investigators
- Dr Nada Wassef, pHD, Study chair, Pediatric Dentistry department, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507359
- Sponsor's protocol ID
- Topical Anaesthia
- Status last verified
- Dec 2022
- First submitted
- 16 Aug 2022
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Application of Clove Gel Versus Benzocaine Gel on Pain Reduction During Application of Simple Dental Procedures in Children: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05507359
- Acronym / sponsor ID
- Topical Anaesthia
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Pain is an unpleasant sensory and emotional experience that arises from actual or potential tissue damage or described in terms of such damage. In pediatric dentistry, pain sensation is generated by stimuli like the touch of the needle at the time of local anesthetic administration and is not necessarily caused by tissue damage. Poor pain control, anxiety, and fear of the needle might interfere with the acceptance of local anesthesia and lead to inappropriate dental treatment management.
Fear and anxiety are the most common problems in pediatric dentistry. Needle phobias and fear of pain due to needle prick are very common in children, compromising their dental health. Therefore, various methods (pharmacological or non-pharmacological) have been developed to overcome this problem. Topical anesthetics are the gold standard method used to alleviate pain.
In pediatric dentistry, local anesthesia is the most common procedure that can trigger fear and anxiety in children, but it is an essential measure for pain control. Therefore, an alternative for injectable anesthesia is the use of topical anesthetics.
Rubber dam placement is one of the procedures used daily in dental practice. Unfortunately, anxiety is triggered when injectable anesthesia is applied to control the pain during rubber dam placement. Children perceive rubber dam clamp placement as a painful procedure.
Using an effective topical anesthetic can prevent pain, leading to establishing a trust-based and positive relationship between the pediatric dentist and the child, eliminating the child's fears and anxiety, and developing a positive attitude towards future dental treatments.
Herbal medicine is widely used by approximately 75-80% of the world's population as it has no side effects, is cost-effective, and is locally available. According to the World Health Organization (WHO), the use of herbal remedies exceeds conventional drugs by two to three times. Clove (Syzygium aromaticum) is used in daily life for various potential health benefits and has been used to relieve toothache for ages. It contains active constituents such as eugenol, gallic acid, and eugenyl acetate. It has anesthetic, analgesic, anti-inflammatory, antimicrobial, antifungal, antidiabetic, and antithrombotic action. The mechanism involved in analgesic activity is the activation of calcium and chloride channels in ganglionar cells. The analgesic effect of eugenol is due to its ability to inhibit prostaglandins and other inflammatory mediators.
In the US and UK, researchers reported that 80 percent of pediatric dentists consider rubber dam the gold standard of care; therefore, it is used frequently in daily practice. It provides a means to avoid moisture contamination during fissure sealant placement, especially in the lower molars that are more prone to suffer from saliva contamination. The British Society of Pediatric Dentistry recommended rubber dams for various procedures, including pit and fissure sealants.
Clove is equally effective with benzocaine as a topical agent. Clove has many advantages as it is more than five times cheaper than other topical anesthetics, leading to lower dental costs. It can reduce the dose of drugs the patient absorbs and is widely available even in rural areas. It is especially beneficial in developing countries where the use of topical anesthetics is limited by cost and availability. Therefore, clove can replace the widely used benzocaine topical anesthetic allowing more patients worldwide to benefit from a largely available and cheap topical anesthetic, Few studies have investigated topical anesthetic use for purposes other than reducing needle-related pain). Topical anesthesia is effective only on the surface tissues up to a depth of 2-3 mm. A major drawback of 20% Benzocaine gel is being washed away easily by saliva due to lack of adhesion; it does not adequately flow into the subgingival spaces.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clove Gel | Experimental | Other: clove gelGroup 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. |
| Benzocaine Gel | Active comparator | Other: Benzocaine gel1. 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Children with any systemic neurological or psychological disorders.
- Children with known allergy to topical or local anesthetic agents or clove.
- Parental refusal of participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clove gel4.7% (Pain Out Dental Gel, Colgate Palmolive India Ltd, Solan, India) clove gel | Other | Clove Gel |
| Benzocaine gel20% Benzocaine gel (Opahl gel) | Other | Benzocaine Gel |
Primary outcome
Pain perception during application of rubber dam or matrix band.
Time frame: 1 day
It is measured by Wong-Baker pain rating scale Scale from (0-10)
2 secondary outcomes
Child behavior during application of rubber dam or matrix band.
Time frame: 1 day
Heart rate during application of rubber dam or matrix band.
Time frame: 1 day.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Results publicationAlqareer, 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Marwa Aly, pHD contact
Dr Nada Wassef, pHD study chair
Pediatric Dentistry department, Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing clove gel and Benzocaine gel in people with Pain, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farah Ihab El Sharkawy, Master (201157671644, Farah.elsharkawy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain perception during application of rubber dam or matrix band. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05507359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022.