Pain Reduction After Separators Placement

NCT05777122 | Unknown Phase 2

• 1 other identifier: KMDC/COD/ESRC/0047/2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Orthodontic Pain

Keywords

pain reduction ,separator, chewing gum, lignocaine gel, VAS

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

group A

EXPERIMENTAL

lignocaine gel every 8 hours

Drug: lignocaine gel

group B

EXPERIMENTAL

chewing gum every 8 hours 5-10 mins chew

Other: sugar free chewing gum

Interventions

lignocaine gel DRUG

pharmacological ,topical anesthetic gel

Also known as: somogel

group A

sugar free chewing gum OTHER

non pharmacological

Also known as: trident

group B

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patient who did not return the completed questionnairs
• Using analgesics or antibiotics

Sponsors & Collaborators

• Sadaf Bashir: lead

Study Sites (1)

Sadaf Bashir

Karachi, Sindh, 75190, Pakistan

Location

MeSH Terms

Interventions

Forkhead Box Protein M1

Intervention Hierarchy (Ancestors)

Forkhead Transcription Factors; Winged-Helix Transcription Factors; DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins; Transcription Factors

Study Officials

• Sadaf Bashir, BDS

  Karachi Medical and Dental College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assessing the effective method of pain reduction after the placement of conventional separators

Model Details: 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

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 21, 2023
• Study Start: January 10, 2022
• Primary Completion: March 12, 2023
• Study Completion: March 16, 2023
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: starting 6 months after publication
• Access Criteria: Sadaf bashir

Locations

PA (1)