Multi-Modal Education to Improve Compliance, Knowledge Retention & Anxiety After Dental Extractions

NCT07191132 | Completed

• 1 other identifier: MDSC_UiTM
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether using a new Post-Dental Extraction Care Kit (PDEC-kit) can help patients better understand and follow their post-extraction instructions, and whether it can also reduce dental anxiety, compared with verbal instructions alone. The study is being conducted among adult patients (18 years and older) undergoing routine tooth extractions under local anaesthesia at a university oral surgery clinic. The main questions this study aims to answer are: Does the PDEC-kit improve patients' knowledge retention about post-extraction care? Does the PDEC-kit improve patient compliance with important post-extraction behaviours (e.g., medication use, diet, activity restrictions)? Does the PDEC-kit reduce patient anxiety compared with standard verbal instructions? Researchers will compare two groups of patients: One group will receive the usual standardised verbal instructions. The other group will receive the same verbal instructions plus the PDEC-kit. Participants in the PDEC-kit group will: Watch a short educational video on post-extraction care. Review illustrated flashcards showing key "dos and don'ts." Observe a live demonstration using a dental model to learn how to place and bite on gauze correctly. Take home a bilingual brochure (English and Bahasa Melayu), also available via QR code. All participants will be asked to answer short questionnaires about their knowledge, behaviour, and dental anxiety at three time points: before the extraction, immediately after receiving instructions, and one week later.

Conditions

Tooth Extraction; Postoperative Complications; Patient Compliance; Dental Anxiety; Patient Education as Topic

Keywords

Tooth Extraction; Postoperative Care; Patient Education; Dental Anxiety; Patient Compliance

Outcome Measures

Primary Outcomes (1)

• Knowledge Retention of Post-Extraction Care

  Knowledge assessed using a structured four-item post-extraction care quiz (binary scoring, correct/incorrect). Higher scores indicate better knowledge retention.

  Baseline (pre-extraction, T0), immediately after instruction (T1), and one-week post-operatively (T2).

Secondary Outcomes (2)

• Dental Anxiety (IDAF-4C+)

  Baseline (T0), immediately after instruction (T1), and one-week post-operatively (T2).

• Patient Compliance with Post-Operative Instructions

  One-week post-operatively (T2).

Other Outcomes (2)

• Self-Reported Pain

  Baseline (T0), immediately after instruction (T1), and one-week post-operatively (T2).

• Post-Operative Complications

  One-week post-operatively (T2).

Study Arms (2)

Standardised Verbal Instructions

ACTIVE COMPARATOR

Participants receive the standardised verbal post-extraction care instructions delivered by a trained investigator using a calibrated script. No additional educational materials are provided.

Behavioral: Standardised Verbal Instructions

Intervention - Verbal Instructions + PDEC-kit

EXPERIMENTAL

Participants receive the same standardised verbal post-extraction instructions as the control group, supplemented with the Post-Dental Extraction Care Kit (PDEC-kit). The kit includes: A 2-minute educational video Illustrated flashcards of dos and don'ts Live demonstration of gauze placement using a dental model Bilingual brochure (English and Bahasa Melayu), with QR code for digital access

Behavioral: Verbal Instructions + PDEC-kit

Interventions

Standardised Verbal Instructions BEHAVIORAL

Participants receive verbal post-extraction care instructions delivered by a trained investigator using a calibrated script. The content includes guidance on bleeding control, diet, oral hygiene, activity restrictions, and medication use.

Standardised Verbal Instructions

Verbal Instructions + PDEC-kit BEHAVIORAL

Participants receive the same standardised verbal instructions as the control group, supplemented with the PDEC-kit. The kit includes a two-minute educational video, illustrated flashcards, a live gauze demonstration using a dental model, and a bilingual (English and Bahasa Melayu) illustrated brochure with QR code access to a digital version.

Intervention - Verbal Instructions + PDEC-kit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older
• Scheduled for routine, non-surgical extraction of one or two adjacent permanent teeth
• Able to read and understand either English or Bahasa Melayu
• =Classified as American Society of Anesthesiologists (ASA) physical status I or II
• Provide written informed consent

You may not qualify if:

• Previous participation in this study
• ASA physical status III or higher
• History of diagnosed anxiety disorders, depression, or learning disabilities
• Requirement for surgical, complex, or multiple extractions
• Procedures expected to be difficult or requiring assistance from a supervising specialist
• Inability to understand or follow study instructions

Sponsors & Collaborators

• Universiti Teknologi Malaysia: lead

Study Sites (1)

Faculty of Dentistry Universiti Teknologi MARA

Sungai Buloh, Selangor, 47000, Malaysia

Location

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MeSH Terms

Conditions

Postoperative Complications; Patient Compliance

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Melissa Mohammad, BDS

  Ministry of Health, Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Care providers performing the dental extractions were blinded to group allocation. Randomization occurred only after the extraction was completed, and the operating clinician was not involved in delivering post-operative instructions. Participants and the investigator providing instructions were not masked due to the nature of the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof. Dr.

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 24, 2025
• Study Start: March 27, 2024
• Primary Completion: July 29, 2024
• Study Completion: August 5, 2024
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months after publication of the primary study results and for up to 5 years thereafter.
• Access Criteria: Data will be available to researchers with a methodologically sound proposal, subject to approval by the principal investigator and UiTM Research Ethics Committee.

Locations

MY (1)