Pain Reduction After Separators Placement

• Sponsor: Sadaf Bashir (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05777122
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14.1
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Orthodontic Pain	Drug: lignocaine gel; Other: sugar free chewing gum	Phase 2

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.

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 .

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 usedIn 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)
• Primary Purpose: Treatment
• Official Title: Assessing the Effective Method of Pain Reduction After the Placement of Conventional Separators
• Actual Study Start Date: Jan 10, 2022
• Anticipated Primary Completion Date: Mar 12, 2023
• Anticipated Study Completion Date: Mar 16, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group A lignocaine gel every 8 hours	Drug: lignocaine gel; pharmacological ,topical anesthetic gel; Other Names: somogel
Experimental: group B chewing gum every 8 hours 5-10 mins chew	Other: sugar free chewing gum; non pharmacological; Other Names: trident

Outcome Measures

Primary Outcome Measures

1. pain reduction [2 hours, at 8 hours , 24 hours, at 2nd day , 3rd day , 5th and 7th day after separator placement.]

   Visual Analog Scale (VAS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sadaf Bashir	Karachi	Sindh	Pakistan	75190

Sponsors and Collaborators

• Sadaf Bashir

Investigators

• Principal Investigator: Sadaf Bashir, BDS, Karachi Medical and Dental College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sadaf Bashir, assessing the effective method of pain reduction after the placement of conventional separators, Karachi Medical and Dental College
• ClinicalTrials.gov Identifier: NCT05777122
• Other Study ID Numbers: KMDC/COD/ESRC/0047/2021
• First Posted: Mar 21, 2023
• Last Update Posted: Mar 21, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Sadaf Bashir, assessing the effective method of pain reduction after the placement of conventional separators, Karachi Medical and Dental College: pain reduction ,separator, chewing gum, lignocaine gel, VAS
• Additional relevant MeSH terms: Lidocaine

Study Results

No Results Posted as of Mar 21, 2023