An Investigation of the Efficacy of OHEM for Improving Oral Hygiene in Children

NCT06356402 | Not Yet Recruiting

• 1 other identifier: 8510224SMCPD
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study evaluates the feasibility of conducting a larger Randomized Controlled Trial to compare three oral health education delivery methods to a control group. Except for the control group, mothers in the three intervention groups will receive the same oral health education based on the OHEM module but differ in the delivery methods, namely lecture, exhibition, and demonstration. All groups will receive a booklet and oral hygiene kits and be instructed to educate their children at home. Pre- and post-intervention assessments include the satisfaction of participants, the researchers' evaluation and cost of the trial, oral hygiene status, and the knowledge of the parents and children.

Conditions

Dental Plaque; Gingivitis

Outcome Measures

Primary Outcomes (3)

• Satisfaction of participants:

  i. Are you satisfied with the program's organisation? ii. Are you satisfied with the researcher's attitude during the trial? iii. Are you satisfied with the recruitment process? iv. Are you satisfied with the intervention process? v. Are you satisfied with the content taught during the intervention? vi. Are you satisfied with the researcher's delivery of the content? vii. Are you satisfied with arranging the OHEM sessions at the venue? viii. Is the environment at the venue conducive to learning? ix. Are you satisfied with the baseline and final stage of the oral screening process? x. Do you trust the researcher that her research will be fruitful for you and your family? The satisfaction will be assessed using a 10-item questionnaire mentioned in the primary objective. Participants will respond to each question using a 5-point Likert scale rating; each item will be reported as the percentage of participants who are at least somewhat satisfied (score 3,4,5)

  six months

• Recruitment and participation of participants in the study

  i) How well participants cooperated 1. During the recruitment/baseline data collection 2. During the intervention 3. During the follow-up/ final data collection process Additional comments by the researcher:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ The recruitment will be assessed on a Likert scale rating (very dissatisfied, dissatisfied, somewhat satisfied, satisfied, very satisfied); each item will be reported as the percentage of participants who are at least somewhat satisfied (score 3,4,5), whereas the participation of the participants will be assessed in percentage.

  six months

• Cost of the trial

  The cost of the trial will be assessed by comparing the cost of the expenditure at the end of the trial. i) Travelling cost, ii) Preparation of materials for the OHEM lecture, exhibition, and demonstration session cost, iii) Conducting the OHEM lecture, exhibition, and demonstration sessions cost, iv) Cost of the incentives for the participants, v) Cost for the volunteers of the trial.

  six months

Secondary Outcomes (5)

• Dental plaque scores

  six months

• Gingival scores

  six months

• Oral health KAP scores

  six months

• Oral health behaviors

  six months

• Oral health-related quality of life using Oral health impact profile-14

  six months

Study Arms (4)

OHEM- Lecture

EXPERIMENTAL

In this arm, OHEM will be delivered by the lecture to the participants.

Behavioral: Oral Health Educational Module for Mothers (OHEM) lecture

OHEM-Exhibition

EXPERIMENTAL

In this arm, OHEM will be delivered by the exhibition to the participants.

Behavioral: Oral Health Educational Module for Mothers (OHEM) exhibition

OHEM-Demonstration

EXPERIMENTAL

In this arm, OHEM will be delivered by the demonstration to the participants.

Behavioral: Oral Health Educational Module for Mothers (OHEM) demonstration

Control

NO INTERVENTION

There will be no educational intervention given to the control group. However, this group will receive oral hygiene kits and a booklet without instruction to teach their children.

Interventions

Oral Health Educational Module for Mothers (OHEM) lecture BEHAVIORAL

OHEM via lecture will be delivered to the mothers by an oral health professional who will be instructed to teach their children.

OHEM- Lecture

Oral Health Educational Module for Mothers (OHEM) exhibition BEHAVIORAL

OHEM via exhibition will be delivered to the mothers who will be instructed to teach their children.

OHEM-Exhibition

Oral Health Educational Module for Mothers (OHEM) demonstration BEHAVIORAL

OHEM via demonstration will be delivered to the mothers by an oral health professional who will be instructed to teach their children.

OHEM-Demonstration

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Mothers with children aged 12 to 15 years old, who are residing in Gulshan-e-Sikandarabad with no plan to move within the next 12 months.
• Mothers with the ability to understand and read the Urdu language.
• Only biological mothers with good physical and psychological health.

You may not qualify if:

• Mothers with new-born
• Mothers with a history of receiving formal oral health promotion or preventive programs.
• Aged 12,13,14, and 15 years old (studying in classes 6,7,8, and 9 respectively) residing in union council Gulshan-e-Sikandrabad,
• Live with biological mothers at home,
• Present with moderate to severe plaque accumulation and gingivitis during oral screening.
• Have genetic or medical conditions, such as physical and psychological disabilities that can affect the comprehension of instruction and tooth brushing activities, such as learning disabilities or auditory or visual disorders.
• Have genetic dental anomalies such as anodontia, amelogenesis imperfecta, and supernumerary teeth.
• Have been previously exposed to any form of oral health education.

Sponsors & Collaborators

• Ziauddin University: lead
• Universiti Sains Malaysia: collaborator

Study Sites (1)

Primary Healthcare Center Gulshan-e-Sikandarabad Shireen Jinnah Colony

Karachi, Pakistan

Location

Related Publications (11)

• Yusoff M. S. B. ABC of content validation and content validity index calculation. J Education in Medicine Journal. 2019;11(2), 49-54.

  BACKGROUND

• World Health Organization. Oral health surveys: basic methods: World Health Organization. 2013.

  BACKGROUND

• Nasa P, Jain R, Juneja D. Delphi methodology in healthcare research: How to decide its appropriateness. World J Methodol. 2021 Jul 20;11(4):116-129. doi: 10.5662/wjm.v11.i4.116. eCollection 2021 Jul 20.

  PMID: 34322364 BACKGROUND

• SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

  PMID: 14158464 BACKGROUND

• LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

  PMID: 14121956 BACKGROUND

• Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.

  PMID: 9332805 BACKGROUND

• Silveira M. F., Pinho L. d. & Brito M. F. S. F. Validity and reliability of the oral health impact profile instrument (OHIP-14) in adolescents. J Paidéia. 2019;29.

  BACKGROUND

• Crews K, O'Hara J, Gordy F, Penton N. The Bass technique: Charles Cassidy Bass' legacy. Miss Dent Assoc J. 1995 Summer;51(2):18-20.

  PMID: 9569849 BACKGROUND

• Newman M. G., Takei H., Klokkevold P. R. & Carranza F. A. Carranza's Clinical Periodontology: Elsevier health sciences. 2011.

  BACKGROUND

• Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.

  PMID: 26092476 BACKGROUND

• Saied-Moallemi Z, Virtanen JI, Ghofranipour F, Murtomaa H. Influence of mothers' oral health knowledge and attitudes on their children's dental health. Eur Arch Paediatr Dent. 2008 Jun;9(2):79-83. doi: 10.1007/BF03262614.

  PMID: 18534175 BACKGROUND

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Interventions

Exhibitions as Topic

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Study Officials

• Sidra Mohiuddin, MDS

  Ziauddin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Basaruddin Ahmad, PhD

CONTACT

+6097665829; basaruddin@usm.my

Shahkamal Hashmi, PhD

CONTACT

Shahkamal.Hashmi@zu.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: April 10, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

PA (1)