Multi-Modal Education to Improve Compliance, Knowledge Retention & Anxiety After Dental Extractions
NCT ID: NCT07191132
Last Updated: 2025-09-24
Study Results
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Basic Information
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COMPLETED
NA
208 participants
INTERVENTIONAL
2024-03-27
2024-08-05
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Standardised Verbal Instructions
Participants receive the standardised verbal post-extraction care instructions delivered by a trained investigator using a calibrated script. No additional educational materials are provided.
Standardised Verbal Instructions
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.
Intervention - Verbal Instructions + PDEC-kit
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
Verbal Instructions + PDEC-kit
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.
Interventions
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Standardised Verbal Instructions
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.
Verbal Instructions + PDEC-kit
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Universiti Teknologi Malaysia
OTHER
Responsible Party
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Tan Su Keng
Associate Prof. Dr.
Principal Investigators
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Melissa Mohammad, BDS
Role: PRINCIPAL_INVESTIGATOR
Ministry of Health, Malaysia
Locations
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Faculty of Dentistry Universiti Teknologi MARA
Sungai Buloh, Selangor, Malaysia
Countries
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References
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Klueber KM, Langdon HL, Barnwell Y. The morphology of the vertical and transverse intrinsic musculature of the tongue in the 15-week human fetus. Acta Morphol Neerl Scand. 1979 Dec;17(4):301-10.
Mayer, R. E. (2021). The Cambridge Handbook of Multimedia Learning (2nd ed.). Cambridge University Press. https://doi.org/10.1017/CBO9781139547369
Svensson L, Hakeberg M, Wide U. Evaluating the validity of the Index of Dental Anxiety and Fear (IDAF-4C+) in adults with severe dental anxiety. Eur J Oral Sci. 2020 Oct;128(5):423-428. doi: 10.1111/eos.12731. Epub 2020 Aug 16.
Fathima T, Kumar MPS. Evaluation of quality of life following dental extraction. J Adv Pharm Technol Res. 2022 Nov;13(Suppl 1):S102-S107. doi: 10.4103/japtr.japtr_361_22. Epub 2022 Nov 30.
Dignam P, Elshafey M, Jeganathan A, Foo M, Park JS, Ratnaweera M. Prevalence and Factors Influencing Post-Operative Complications following Tooth Extraction: A Narrative Review. Int J Dent. 2024 May 9;2024:7712829. doi: 10.1155/2024/7712829. eCollection 2024.
Alvira-Gonzalez J, Gay-Escoda C. Compliance of postoperative instructions following the surgical extraction of impacted lower third molars: a randomized clinical trial. Med Oral Patol Oral Cir Bucal. 2015 Mar 1;20(2):e224-30. doi: 10.4317/medoral.20121.
Udeabor SE, Heselich A, Al-Maawi S, Alqahtani AF, Sader R, Ghanaati S. Current Knowledge on the Healing of the Extraction Socket: A Narrative Review. Bioengineering (Basel). 2023 Sep 29;10(10):1145. doi: 10.3390/bioengineering10101145.
Shenoi RS, Rajguru JG, Parate SR, Ingole PD, Khandaitkar SR, Karmarkar JS. Compliance of postoperative instructions following the surgical extraction of impacted lower third molars. Indian J Dent Res. 2021 Jan-Feb;32(1):87-91. doi: 10.4103/ijdr.IJDR_323_20.
Ploghaus A, Narain C, Beckmann CF, Clare S, Bantick S, Wise R, Matthews PM, Rawlins JN, Tracey I. Exacerbation of pain by anxiety is associated with activity in a hippocampal network. J Neurosci. 2001 Dec 15;21(24):9896-903. doi: 10.1523/JNEUROSCI.21-24-09896.2001.
Ikmalhisam, N., Aziz, N., Mah, M., Jamaluddin, T., Wahab, H., Mohammad, M., & Tan, S. (2021). Delivery of Post-Dental Extraction Care Instructions with the Aid of a Novel Educational Kit: The UiTM Dental Students' Perspective. ESTEEM Academic Journal, 17, 135-146.
Houts PS, Witmer JT, Egeth HE, Loscalzo MJ, Zabora JR. Using pictographs to enhance recall of spoken medical instructions II. Patient Educ Couns. 2001 Jun;43(3):231-42. doi: 10.1016/s0738-3991(00)00171-3.
Dingley C, Daugherty K, Derieg MK, Persing R. Improving Patient Safety Through Provider Communication Strategy Enhancements. In: Henriksen K, Battles JB, Keyes MA, Grady ML, editors. Advances in Patient Safety: New Directions and Alternative Approaches (Vol. 3: Performance and Tools). Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK43663/
Choi SH, Won JH, Cha JY, Hwang CJ. Effect of Audiovisual Treatment Information on Relieving Anxiety in Patients Undergoing Impacted Mandibular Third Molar Removal. J Oral Maxillofac Surg. 2015 Nov;73(11):2087-92. doi: 10.1016/j.joms.2015.06.175. Epub 2015 Jul 8.
Baharuddin IH, Arifin WN, Kueh YC, Rahman NA. Adaptation and Validation of the Malay Version of the Index of Dental Anxiety and Fear (IDAF-4C+) for Malaysian Secondary School Children. Malays J Med Sci. 2018 May;25(3):111-119. doi: 10.21315/mjms2018.25.3.11. Epub 2018 Jun 28.
Armfield JM. Development and psychometric evaluation of the Index of Dental Anxiety and Fear (IDAF-4C+). Psychol Assess. 2010 Jun;22(2):279-87. doi: 10.1037/a0018678.
Other Identifiers
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MDSC_UiTM
Identifier Type: -
Identifier Source: org_study_id
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