Orthodontic PainPhase 2NCT05777122
Pain Reduction After Separators Placement
A Phase 2 study testing lignocaine gel and sugar free chewing gum in people with Orthodontic Pain, run by Sadaf Bashir at 1 site in Pakistan.
Trial summary
Rationale of study: Separators placement is the primary step in orthodontic treatment and it is almost always accompanied by pain and discomfort which has a direct impact on the compliance and quality of life of patients. Read more about this study
- Who is it for?
- Ages 12 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Pain
- What is being tested?
- lignocaine gel and sugar free chewing gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2022to 16 Mar 2023
- Phase
- Phase 2
- 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 12 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy with no significant medical finding
- Currently not taking antibiotics or analgesics
- No contraindication to the use of chewing gum/topical analgesics
- Minimum age 12 years ,maximum age 30 years
- Literate/English speaking
Who cannot join
- Patient who did not return the completed questionnairs
- Using analgesics or antibiotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Effective Method of Pain Reduction After the Placement of Conventional Separators
Rationale of study:
Separators placement is the primary step in orthodontic treatment and it is almost always accompanied by pain and discomfort which has a direct impact on the compliance and quality of life of patients. Many pharmacological methods over the past years have been recommended to ease the pain and discomfort and make orthodontic treatment more acceptable .These methods have adverse effects and hence it would be beneficial if we propose a method which will satisfy the patients and will be suitable for them to follow with minimal side effects and maximum efficacy.
Null hypothesis: lignocaine gel and chewing gum will be equally effective in reducing pain after separator placement Alternative hypothesis: lignocaine gel will be more effective than chewing gum in reducing pain after separator placement
Read the detailed description
Data will be collected from subjects reporting to the department of orthodontics, Karachi Medical and Dental College. This study will be started after submission of the synopsis and after approval of the Ethical Review Committee.
Following the placement of separators participant will be randomly assigned in to 2 groups.It is a parallel group randamization.In this study the topical gel (lignocaine ) and a sugar free gum that is commercially available is purchased from the local market. The composition of lignocaine gel is given .Manual allocation using sealed envelope during enrolment of patient in the study. This enabled approximately equal distribution of patients from each group.
- st group: Topical gel (lignocaine gel)
- nd group: chewing gum In our study all the participant were asked to fill the questionnaire. A written informed consent was acquired from all patients for inclusion in the study.
In the topical gel group the patients were directed to apply the gel on the buccal free gingival margin of their first molar at one side when the separators are placed and reapply the gel every 8 hours . They were then requested to mark their level of pain at 2 and 8 hours and at 10 pm of the 2nd,3rd,5th and 7th day after the gel is being applied and mark it on the VAS form.
The patients in the chewing gum group were advised to chew sugar free gum for 5 minutes immediately after separators were placed and at 8 hours interval. The patients were also advised and motivated not to take any additional analgesics.
For measuring the perception of pain the most reliable method is the Visual Analog Scale (VAS).It is a psychometric pain response scale.VAS is a measurement instrument for subjective characters such as pain which cannot be measured directly.
The VAS form was filled in by the patients at baseline after separator placement at 2 hours, at 8 hours , 24 hours, at 2nd day , 3rd day , 5th and 7th day after separator placement. When replying to the VAS performa , the patients were requested to state their severity of pain by marking a position along a calibrated straight continous line weighted at both ends by descriptive terminology with a happy face and a sad face and document the severity of pain when the jaws are at rest and during the biting activity.The degree of pain was determined solely , based on patients conviction through VAS cards and questionnaire .
- Conditions
- Orthodontic Pain
- Being tested
- lignocaine gel, sugar free chewing gum
- Keywords
- pain reduction ,separator, chewing gum, lignocaine gel, VAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lignocaine gelDrug
Also called somogel
pharmacological ,topical anesthetic gel
sugar free chewing gumOther
Also called trident
non pharmacological
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | lignocaine gel every 8 hours Receives: Drug: lignocaine gel |
| group B | Experimental | chewing gum every 8 hours 5-10 mins chew Receives: Other: sugar free chewing gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain reduction
Visual Analog Scale (VAS)
Measured: 2 hours, at 8 hours , 24 hours, at 2nd day , 3rd day , 5th and 7th day after separator placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start10 Jan 2022
- Primary completion12 Mar 2023 (estimated)
- Study completion16 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic PainStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In our study all the participant were asked to fill the questionnaire.In the topical gel group the patients were directed to apply the gel on the buccal free gingival margin of their first molar at one side when the separators are placed and reapply the gel every 8 hours . T'hey were then requested to mark their level of pain at 2 and 8 hours and at 10 pm of the 2nd,3rd,5th and 7th day after the gel is being applied and mark it on the VAS form. The patients in the chewing gum group were advised to chew sugar free gum for 5 minutes immediately after separators were placed and at 8 hours interval. The patients were also advised and motivated not to take any additional analgesics.For measuring the perception of pain the most reliable method the Visual Analog Scale (VAS).will be used
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sadaf Bashir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sadaf Bashir, Karachi Medical and Dental College
- Investigators
- Sadaf Bashir, BDS, Principal investigator, Karachi Medical and Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777122
- Sponsor's protocol ID
- KMDC/COD/ESRC/0047/2021
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: response to each variable of the questionnaire, name, age , occupation,gender,
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effective Method of Pain Reduction After the Placement of Conventional Separators
- ClinicalTrials.gov ID
- NCT05777122
- Acronym / sponsor ID
- KMDC/COD/ESRC/0047/2021
- Conditions
- Orthodontic Pain
- Keywords
- pain reduction ,separator, chewing gum, lignocaine gel, VAS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sadaf BashirUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 12 Mar 2023 (estimated)
- Study completion
- 16 Mar 2023 (estimated)
- First posted
- 21 Mar 2023 (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.
Rationale of study:
Separators placement is the primary step in orthodontic treatment and it is almost always accompanied by pain and discomfort which has a direct impact on the compliance and quality of life of patients. Many pharmacological methods over the past years have been recommended to ease the pain and discomfort and make orthodontic treatment more acceptable .These methods have adverse effects and hence it would be beneficial if we propose a method which will satisfy the patients and will be suitable for them to follow with minimal side effects and maximum efficacy.
Null hypothesis: lignocaine gel and chewing gum will be equally effective in reducing pain after separator placement Alternative hypothesis: lignocaine gel will be more effective than chewing gum in reducing pain after separator placement
Detailed description
Data will be collected from subjects reporting to the department of orthodontics, Karachi Medical and Dental College. This study will be started after submission of the synopsis and after approval of the Ethical Review Committee.
Following the placement of separators participant will be randomly assigned in to 2 groups.It is a parallel group randamization.In this study the topical gel (lignocaine ) and a sugar free gum that is commercially available is purchased from the local market. The composition of lignocaine gel is given .Manual allocation using sealed envelope during enrolment of patient in the study. This enabled approximately equal distribution of patients from each group.
- st group: Topical gel (lignocaine gel)
- nd group: chewing gum In our study all the participant were asked to fill the questionnaire. A written informed consent was acquired from all patients for inclusion in the study.
In the topical gel group the patients were directed to apply the gel on the buccal free gingival margin of their first molar at one side when the separators are placed and reapply the gel every 8 hours . They were then requested to mark their level of pain at 2 and 8 hours and at 10 pm of the 2nd,3rd,5th and 7th day after the gel is being applied and mark it on the VAS form.
The patients in the chewing gum group were advised to chew sugar free gum for 5 minutes immediately after separators were placed and at 8 hours interval. The patients were also advised and motivated not to take any additional analgesics.
For measuring the perception of pain the most reliable method is the Visual Analog Scale (VAS).It is a psychometric pain response scale.VAS is a measurement instrument for subjective characters such as pain which cannot be measured directly.
The VAS form was filled in by the patients at baseline after separator placement at 2 hours, at 8 hours , 24 hours, at 2nd day , 3rd day , 5th and 7th day after separator placement. When replying to the VAS performa , the patients were requested to state their severity of pain by marking a position along a calibrated straight continous line weighted at both ends by descriptive terminology with a happy face and a sad face and document the severity of pain when the jaws are at rest and during the biting activity.The degree of pain was determined solely , based on patients conviction through VAS cards and questionnaire .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In our study all the participant were asked to fill the questionnaire.In the topical gel group the patients were directed to apply the gel on the buccal free gingival margin of their first molar at one side when the separators are placed and reapply the gel every 8 hours . T'hey were then requested to mark their level of pain at 2 and 8 hours and at 10 pm of the 2nd,3rd,5th and 7th day after the gel is being applied and mark it on the VAS form. The patients in the chewing gum group were advised to chew sugar free gum for 5 minutes immediately after separators were placed and at 8 hours interval. The patients were also advised and motivated not to take any additional analgesics.For measuring the perception of pain the most reliable method the Visual Analog Scale (VAS).will be used
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: lignocaine gellignocaine gel every 8 hours |
| group B | Experimental | Other: sugar free chewing gumchewing gum every 8 hours 5-10 mins chew |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Healthy with no significant medical finding
- Currently not taking antibiotics or analgesics
- No contraindication to the use of chewing gum/topical analgesics
- Minimum age 12 years ,maximum age 30 years
- Literate/English speaking
Key exclusion criteria (2 listed)
- Patient who did not return the completed questionnairs
- Using analgesics or antibiotics
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 |
|---|---|---|
| lignocaine gelAlso: somogelpharmacological ,topical anesthetic gel | Drug | group A |
| sugar free chewing gumAlso: tridentnon pharmacological | Other | group B |
Primary outcome
pain reduction
Time frame: 2 hours, at 8 hours , 24 hours, at 2nd day , 3rd day , 5th and 7th day after separator placement.
Visual Analog Scale (VAS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Individual participant dataSharing planned: Yes. response to each variable of the questionnaire, name, age , occupation,gender,
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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.
Sadaf Bashir, BDS principal investigator
Karachi Medical and Dental College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lignocaine gel and sugar free chewing gum in people with Orthodontic Pain, run by Sadaf Bashir at 1 site in Pakistan.
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 5 inclusion and 2 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 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain reduction (time frame: 2 hours, at 8 hours , 24 hours, at 2nd day , 3rd day , 5th and 7th day after separator placement.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2023.