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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05777122
Other study ID # KMDC/COD/ESRC/0047/2021
Secondary ID
Status Enrolling by invitation
Phase Phase 2
First received
Last updated
Start date January 10, 2022
Est. completion date March 16, 2023

Study information

Verified date March 2023
Source Karachi Medical and Dental College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


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. 1. st group: Topical gel (lignocaine gel) 2. 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 .


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 60
Est. completion date March 16, 2023
Est. primary completion date March 12, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 30 Years
Eligibility Inclusion Criteria: 1. Healthy with no significant medical finding 2. Currently not taking antibiotics or analgesics 3. No contraindication to the use of chewing gum/topical analgesics 4. Minimum age 12 years ,maximum age 30 years 5. Literate/English speaking Exclusion Criteria: 1. Patient who did not return the completed questionnairs 2. Using analgesics or antibiotics

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
lignocaine gel
pharmacological ,topical anesthetic gel
Other:
sugar free chewing gum
non pharmacological

Locations

Country Name City State
Pakistan Sadaf Bashir Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Sadaf Bashir

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary pain reduction Visual Analog Scale (VAS) 2 hours, at 8 hours , 24 hours, at 2nd day , 3rd day , 5th and 7th day after separator placement.
See also
  Status Clinical Trial Phase
Completed NCT05844995 - A Study of Acetaminophen/Naproxen Sodium Fixed Combination Tablets in Adolescents 12 to <17 Years of Age With Pain Phase 1
Recruiting NCT03816943 - The Influence of Communication After Placement of Orthodontic Fixed Appliances on Pain, Anxiety and Oral Health Quality of Life Among Malaysian Population N/A
Recruiting NCT04836234 - Chewing Gum Effect in Reducing Orthodontic Pain After Separator and Initial Arch Wire Placement N/A
Completed NCT00484744 - Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement Phase 4
Recruiting NCT03755622 - Comparing Clinical Application of Innovatedly Made Transpalatal Arch (TPA) From 3D Reconstructed Model and Conventionally Made TPA N/A
Withdrawn NCT05845008 - A Multiple-Dose Safety Study of Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents With Orthodontic Pain Phase 3
Recruiting NCT04834466 - Factors Associated With Pain Level Experience in Orthodontic Treatment