Last reviewed · How we verify
NCT03844425
Microbial Colonisation On Vacuum-Formed Retainers Constructed On Conventional Models And Three Dimensional (3D) Reconstructed Models
NA trial testing Conventional VFR in Orthodontic Appliance Complication in 36 participants. Completed in 10 April 2021.
10 April 2021
Quick facts
| Lead sponsor | University of Malaya |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | screening |
| Enrollment | 36 |
| Start date | 2 December 2019 |
| Primary completion | 10 April 2021 |
| Estimated completion | 10 April 2021 |
| Sites | 1 location across Malaysia |
Drugs / interventions tested
- Conventional VFR
- VFR from SLA
- VFR from FDM
Conditions studied
- Orthodontic Appliance Complication — all drugs for Orthodontic Appliance Complication →
Sponsor
University of Malaya
Who can join
Eligibility, any sex, with Orthodontic Appliance Complication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Vacuum-formed retainers are clear or transparent retainers, that hold the teeth in the new position after active orthodontic treatment. These custom made appliances are becoming popular these days due to the aesthetics value among patients. Vacuum-formed retainers can be made through a process that softens the clear plastic and vacuumed to follow the shape of the dental model before it cools off and hardens again. These dental models can be made from conventional method or through a 3D reconstruction process. Recently, it was found that there is no difference in terms of stability of the teeth and oral health related quality of life of the patients wearing vacuum-formed retainers constructed on either types of models. Physically, the surface roughness of the retainers appear different because the conventional models and 3D printed models are constructed in a different manner. Our interest is to determine whether the difference in surface roughness would affect microbial colonisation which can eventually affect the oral health. So this study aims to find the association between microbial colonisation and surface roughness of vacuum-formed retainers constructed on conventional models and also 3D reconstructed models.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Retention procedures for stabilising tooth position after treatment with orthodontic braces.
Martin C, Littlewood SJ, Millett DT, Doubleday B, et al · · 2023 · cited 20× · PMID 37219527 · DOI 10.1002/14651858.cd002283.pub5 -
Microbial adherence on vacuum-formed retainers with different surface roughness as constructed from conventional stone models and 3D printed models: a randomized controlled clinical trial.
Belayutham S, Wan Hassan WN, Razak FA, Mohd Tahir NNZ. · · 2023 · cited 1× · PMID 36947263 · DOI 10.1007/s00784-023-04940-4
Verify or expand the search:
- PubMed search for NCT03844425
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Orthodontic Appliance Complication
Currently open trials in the same condition.
- NCT06944860 — Microbial Adherence, Surface Roughness, Effectiveness and Impact on Patients Between Conventional and 3D Printed Twin Bl · NA · recruiting
- NCT06573996 — The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain · NA · recruiting
- NCT06502886 — Evaluation of The Stability of Orthodontic Treatment After First Premolar Extraction Using Combined Retention Protocol · NA · recruiting
- NCT05733676 — Comparison of MI Paste Plus and Resin Infiltration in White Spot Lesions Following Orthodontic Treatment · NA · recruiting
Other University of Malaya trials
Trials by the same sponsor.
- NCT07398066 — DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial) · NA · not yet recruiting
- NCT07522463 — Enhancing Attention and Processing Speed Through Home-based Music Rehabilitation Program After Stroke in Malaysia · NA · not yet recruiting
- NCT07341802 — Pilot Feasibility Study of a Fall Prevention Exercise Programme for Community-dwelling Older Adults in Nanchang, China · NA · recruiting
- NCT07452705 — Small Study Comparing Two Pain Medicines in Teenagers for Pain Control After Scoliosis Corrective Surgery. · NA · not yet recruiting
- NCT07369596 — Impact of Chemotherapy Dose Reductions on Survival Outcomes Among Older NSCLC Patients Without Actionable Mutations · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03844425 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Malaya
- Last refreshed: 26 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03844425.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing