Faculty of Dentistry Universiti Teknologi MARA
Sungai Buloh, Selangor, 47000, Malaysia
NCT Number: NCT07191132
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Sungai Buloh, Selangor, 47000, Malaysia
Scientific Rationale
Tooth extraction is one of the most frequently performed dental procedures. Despite its routine nature, poor comprehension of post-operative instructions may lead to complications such as alveolar osteitis, infection, or delayed wound healing. Evidence from health communication research shows that patients retain only a small proportion of verbal-only instructions, particularly in settings of heightened anxiety. Multimedia learning theory (Mayer, 2021) suggests that simultaneous delivery of verbal, visual, and kinesthetic information enhances encoding and recall.
Building on this theory, the Post-Dental Extraction Care Kit (PDEC-kit) was developed. It integrates audiovisual, pictorial, and demonstration-based teaching into a structured package that supplements standard verbal guidance. The central hypothesis is that the PDEC-kit improves knowledge retention, compliance, and anxiety outcomes compared to verbal instructions alone.
Study Design Overview
This is a prospective, single-centre, two-arm, parallel-group randomized controlled trial. Participants are assigned to intervention or control groups in a 1:1 ratio. Allocation concealment was ensured using block randomisation with opaque, sequentially numbered envelopes. Operators performing extractions were blinded to allocation.
The sample size was determined by a priori power analysis using G*Power 3.1, based on a medium effect size (f = 0.25), α = 0.05, power = 0.80, and repeated measures across two groups. The minimum required sample was 86; recruitment was increased to 208 to account for attrition.
Intervention Details
Control arm: Standardised verbal post-extraction instructions delivered by a single calibrated investigator to minimise variability.
Intervention arm: Same standardised verbal instructions plus the PDEC-kit, which consists of:
Educational video (2 minutes): Demonstrates correct gauze placement, oral hygiene, and activity restrictions.
Illustrated flashcards: Show simplified dos and don'ts using pictorial reinforcement.
Live model demonstration: Gauze placement demonstrated on a dental model for kinesthetic learning.
Bilingual brochure (English and Bahasa Melayu): Provides at-home reference; a QR code enables access to a digital version.
All components were pilot-tested for clarity and developed by a multidisciplinary panel of oral surgeons, dental educators, and communication specialists.
Assessment Schedule
Data collection was performed at three points:
T0: Baseline (pre-extraction) - demographic data, knowledge baseline, and anxiety baseline.
T1: Immediately after instruction - post-intervention knowledge and anxiety assessments.
T2: One-week follow-up via telephone - reassessment of knowledge retention, anxiety, compliance, and complications.
Measurement Instruments
Knowledge retention: Four-item structured quiz (binary scoring).
Dental anxiety: Index of Dental Anxiety and Fear (IDAF-4C+, validated Malay version).
Compliance: Structured checklist covering analgesic use, diet, hygiene, activity, and smoking behaviour.
Pain: 10-point Likert scale.
Complications: Self-reported bleeding, infection, or alveolar osteitis, confirmed by clinic review where indicated.
Analytic Framework
Data were analysed using SPSS v29. Statistical procedures included:
Descriptive statistics for demographic and baseline variables.
Independent-samples t-test for between-group comparisons.
Paired-samples t-test for within-group pre-post changes.
Repeated measures ANOVA (Greenhouse-Geisser correction applied when sphericity violated).
Chi-square test for categorical variables (compliance, complication rates).
Spearman's correlation for anxiety-pain association. Significance threshold: p < 0.05.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-=Classified as American Society of Anesthesiologists (ASA) physical status I or II
Exclusion criteria
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.
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.
Time frame: Baseline (pre-extraction, T0), immediately after instruction (T1), and one-week post-operatively (T2).
Knowledge assessed using a structured four-item post-extraction care quiz (binary scoring, correct/incorrect). Higher scores indicate better knowledge retention.
Time frame: Baseline (T0), immediately after instruction (T1), and one-week post-operatively (T2).
Level of dental anxiety measured using the validated Index of Dental Anxiety and Fear (IDAF-4C+), including core, phobia, and stimulus modules.
Structure:
Scoring:
Core module total score range: 8 (minimum) to 40 (maximum). Interpretation: Higher scores indicate a worse outcome (greater dental anxiety/fear).
Phobia and stimulus modules are analyzed separately; higher values indicate greater anxiety/fear or avoidance.
Time frame: One-week post-operatively (T2).
Adherence to specific behaviours (analgesic use, diet, oral hygiene, activity restriction, and smoking cessation) assessed using a structured compliance checklist adapted from Shenoi et al. (2021).
Time frame: Baseline (T0), immediately after instruction (T1), and one-week post-operatively (T2).
Pain severity assessed using a 10-point Likert numerical rating scale (0 = no pain; 10 = worst possible pain).
Time frame: One-week post-operatively (T2).
Self-reported complications including bleeding, infection, or alveolar osteitis, confirmed by clinic follow-up where necessary.
Universiti Teknologi Malaysia
Other
Integrating Multi-Modal Education to Improve Patient Compliance, Knowledge Retention, and Anxiety Reduction After Dental Extractions: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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