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Tooth ExtractionNCT07191132

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

A study testing Standardised Verbal Instructions and Verbal Instructions + PDEC-kit in people with Tooth Extraction and Postoperative Complications, run by Universiti Teknologi Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Standardised Verbal Instructions and Verbal Instructions + PDEC-kit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
1 siteMalaysia
Study dates
27 Mar 2024to 5 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site
  • Faculty of Dentistry Universiti Teknologi MARA

    Sungai Buloh, Selangor, 47000

Other trials in Malaysia

About this study

Official title: Integrating Multi-Modal Education to Improve Patient Compliance, Knowledge Retention, and Anxiety Reduction After Dental Extractions: A Randomized Controlled Trial

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:

Read more

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.

Read the detailed description

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.

Being tested
Standardised Verbal Instructions, Verbal Instructions + PDEC-kit
Keywords
Tooth Extraction, Postoperative Care, Patient Education, Dental Anxiety, Patient Compliance
Medical subject headings
Postoperative Complications, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standardised Verbal InstructionsBehavioural

    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-kitBehavioural

    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.

Study groups in NCT07191132
Study groupRoleWhat they receive
Standardised Verbal InstructionsActive comparatorParticipants receive the standardised verbal post-extraction care instructions delivered by a trained investigator using a calibrated script. No additional educational materials are provided.
Receives: Behavioral: Standardised Verbal Instructions
Intervention - Verbal Instructions + PDEC-kitExperimentalParticipants 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
Receives: Behavioral: Verbal Instructions + PDEC-kit

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)
  1. Dental Anxiety (IDAF-4C+)

    Level of dental anxiety measured using the validated Index of Dental Anxiety and Fear (IDAF-4C+), including core, phobia, and stimulus modules.

    Structure:

    • Core module (8 items): Each item is scored on a 5-point Likert scale (1 = Disagree to 5 = Strongly agree).
    • Phobia module (5 items, Yes/No): Screens for dental phobia.
    • Stimulus module (10 items): Rates fear related to specific dental stimuli and situations on a 5-point scale (1 = Not at all to 5 = Very much).

    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.

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

  2. Patient Compliance with Post-Operative Instructions

    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).

    Measured: One-week post-operatively (T2).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2025
  2. Study start27 Mar 2024
  3. Primary completion29 Jul 2024
  4. Study completion5 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07191132
Sponsor's protocol ID
MDSC_UiTM
Status last verified
Sep 2025
First submitted
19 Sep 2025
Last updated
24 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) that underlie the results reported in published articles will be made available to other researchers. De-identified individual participant data underlying the primary and secondary outcomes reported in the main publication. How to access data: Requests should be submitted to the corresponding author (Tan Su Keng, Centre of Studies for Oral \& Maxillofacial Surgery, Universiti Teknologi MARA). Approved requests will require a signed data use agreement, and data will be shared via secure e

Publications

  • Kessels RP. Patients' memory for medical information. J R Soc Med. 2003 May;96(5):219-22. doi: 10.1177/014107680309600504. No abstract available.

    PubMed 12724430
  • 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.

    PubMed 33463781
  • 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.

    PubMed 36643114
  • 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.

    PubMed 38756385
  • 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.

    PubMed 25475774
  • 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.

    PubMed 37892875
  • 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.

    PubMed 34269243
  • 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.

    PubMed 11739597
  • 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.

    PubMed 11384821
  • 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/

    PubMed 21249923
  • 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.

    PubMed 26212090
  • 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.

    PubMed 30899192
  • 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.

    PubMed 20528055

Questions about this trial

What is this clinical trial studying?

A study testing Standardised Verbal Instructions and Verbal Instructions + PDEC-kit in people with Tooth Extraction and Postoperative Complications, run by Universiti Teknologi Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge Retention of Post-Extraction Care (time frame: Baseline (pre-extraction, T0), immediately after instruction (T1), and one-week post-operatively (T2).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07191132, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.

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