Oral Health Education and Message Framing Effect on Oral Health Status of Refugees in Egypt

Effect of Message Framing Through M-Health on Oral Health Conditions and Oral Health Related Quality of Life Among Refugees in Alexandria, Egypt: A Randomized Controlled Clinical Trial

Refugees, facing forced displacement and often exposed to traumatic experiences, represent a vulnerable population with unique healthcare needs. Oral health is considered a prominent factor that contributes to quality of life.

Therefore, this study aim at assessing the effect of message framing on enhancing oral health practices in a group of refugees in Alexandria, Egypt. A three-arm cluster randomized controlled clinical trial will compare a gain-framed mobile text messages group, a loss-framed mobile text messages group, and a control group. The primary outcome is the improvement in oral health practices measured by changes in dental plaque and secondary outcome is to assess change in oral health-related quality of life. In addition, oral health knowledge, attitudes, and practices of refugees will be assessed.

Study Overview

• Status: Recruiting
• Conditions: Gingivitis; Plaque, Dental; Knowledge, Attitudes, Practice; Caries,Dental; Pocket, Periodontal
• Intervention / Treatment: Behavioral: Gain and loss framed mobile text messages

• Study Type: Interventional
• Enrollment (Estimated): 510
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dina Attia, PhD student; Phone Number: +20 12 80914529; Email: dina.ali@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt, 21523
    • Recruiting
    • Caritas
    • Contact: Caritas; Phone Number: +20 2 24 31 02 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Refugees older than 18 years old.
• From Arabic speaking countries.
• Has been resident in Alexandria, Egypt for at least 6 months.
• Having mobile phones to receive text messages.
• Agrees to participate in the study.

Exclusion Criteria:

• Planning to move away during 1 year study period.
• Participating in any kind of oral health education and promotion programs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gain-framed messages; The participants will receive every 2 weeks a boosting reminder mobile text message in a gain-framed way. For example, "Great breath, healthy gums only a toothbrush away" "flossing your teeth daily removes particles of food in the mouth, avoiding bacteria, which promotes great breath."	Behavioral: Gain and loss framed mobile text messages; To assess the effect of message framing on enhancing oral health practices in a group of refugees
Experimental: Loss-framed message; he participants will receive every 2 weeks a boosting reminder mobile text message in a loss-framed way. For example, "Brush now and avoid bad breath and gum disease", "If you don't floss your teeth daily, particles of food remain in the mouth, collecting bacteria, which causes bad breath."	Behavioral: Gain and loss framed mobile text messages; To assess the effect of message framing on enhancing oral health practices in a group of refugees
No Intervention: Control group; Participants allocated to this group will not receive mobile text messages. They will only receive the oral health education session given to all participants at the beginning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral health knowledge improvement	To assess change in level of oral health knowledge before and after program using a validated questionnaire	Immediately after structured oral health session, 6 months and 1 year after baseline
Oral health practices improvement	Assess toothbrushing and flossing frequency before and after the education session and reminder mobile messages	6 months and 1 year after baseline
Oral hygiene status assesment	measure the change in plaque index scores among participants	6 months and 1 year after baseline
Gingival health assessment	measure the change in gingival index scores among participants	6 months and 1 year after baseline
Periodontal health status	measure the change in CPI index scores among participants	6 months and 1 year after baseline

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Director: Mona El Kashlan, Professor, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 12, 2024
• First Submitted That Met QC Criteria: October 17, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Plaque; Dental caries; Gingivitis; KAP
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Tooth Demineralization; Tooth Diseases; Dental Deposits; Periodontitis; Gingivitis; Dental Caries; Dental Plaque; Periodontal Pocket
• Other Study ID Numbers: Refugees oral health education

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study protocol and assessment forms.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No