Chewing Gum Effect in Reducing Orthodontic Pain After Separator and Initial Arch Wire Placement
5. april 2021 oppdatert av: University of Malaya
The Effect of the Chewing Gum in Alleviating Orthodontic Pain After Separator and Initial Arch Wire Placement: A Randomized Clinical Trial
Pain is the most claimed complaint from orthodontic treatment.
Fear of pain has contributed to patients' avoidance of seeking orthodontic treatment, affects patients' compliance to treatment and even becomes the main reason for discontinuing orthodontic treatment.
For years, orthodontic patients have reported using analgesics during orthodontic treatment to ease the pain.
However, analgesics have many side effects such as allergic reactions, bleeding disorders, gastric ulcers, liver toxicity and their potential influence in slowing down tooth movement.
This study aimed to investigate the effectiveness of chewing gums in pain reduction in Malaysian multi-ethnic orthodontic patients and to explore the possibility of chewing gum to be recommended as a suitable substitute for analgesics in our future practice.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Orthodontic treatment have been shown to cause varying degrees of discomforts and pain to the patients. Fear of pain has contributed to patients' avoidance of seeking orthodontic treatment, affect patients' compliance to the treatment and even become a main reason of discontinuing orthodontic treatment. Patients have reported using of analgesic particularly NSAIDS and Paracetamol during orthodontic treatment to ease the pain. However, NSAIDS have been associated with various side effects such as allergic reactions, bleeding disorders and gastric ulcers had raised the concern of orthodontists. Studies on animals have shown that NSAIDS slower the rate of tooth movement, hence affecting orthodontic treatment efficacy. Paracetamol have been reported to cause liver toxicity in the case of over dosage.
The action of chewing the gum can produce forces to temporary displace the teeth sufficiently to allow blood flow through compressed area, preventing the build-up of metabolic products, thus reduce the pain severity. In addition, non-sugared chewing gum has anti-caries effect which is very important to prevent caries formation during orthodontic treatment.
This study aimed to investigate the effectiveness of chewing gum in pain reduction in orthodontic patients and to explore the possibility of chewing gum to be recommended as a suitable substitute for analgesics in future practice.
Studietype
Intervensjonell
Registrering (Forventet)
108
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Poon Pei San
- Telefonnummer: 0127691145
- E-post: peisanpss@gmail.com
Studer Kontakt Backup
- Navn: Siti Adibah Othman, Prof
- Telefonnummer: 012-2635088
- E-post: sitiadibah@um.edu.my
Studiesteder
-
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Wilayah Persekutuan Kuala Lumpur
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Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 50603
- Rekruttering
- Postgraduate Orthodontic Clinic, Faculty of Dentistry, University Malaya
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Ta kontakt med:
- Pei San Poon
- Telefonnummer: 0127691145
- E-post: peisanpss@gmail.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
16 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patients about to undergo orthodontic treatment with maxillary and mandibular fixed appliances
- Orthodontic treatment include the extraction of the permanent first or second premolars
- Age 16 years and above
Exclusion Criteria:
- Significant medical problem or cleft lip and palate.
- Pregnant lady
- Occurrence of using analgesics or antibiotics
- History of asthma or unstable asthma the last year
- Oral surgery in the previous 4 weeks
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: intervention group
Participants will receive Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum.
They will be instructed to chew the gum for pain relief after the separator and initial arch wire placement if required.
Chew the gums for 10-12 minutes and as much as they want whenever they feel discomfort or pain.
They are free to take any medication when necessary and respond to the questionnaires on the amount of chewing gum and analgesics used.
|
Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum 65g 40 pieces
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Ingen inngripen: Control group
Participants will not receive any prescription after the separators and initial arch wires placement.
They will be specifically asked not to chew chewing gum.
As in the intervention group, they can take any medication when they feel necessary and respond to the questionnaires on the amount of analgesics used.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain assessment after separators and initial arch wire placement.
Tidsramme: At 6 hours after separators and initial arch wire placement.
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Level of pain on the Numerical pain rating scale (NRS)
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At 6 hours after separators and initial arch wire placement.
|
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Pain assessment after separators and initial arch wire placement.
Tidsramme: At 24 hours after separators and initial arch wire placement.
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Level of pain on the Numerical pain rating scale (NRS)
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At 24 hours after separators and initial arch wire placement.
|
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Pain assessment after separators and initial arch wire placement.
Tidsramme: At 48 hours after separators and initial arch wire placement.
|
Level of pain on the Numerical pain rating scale (NRS)
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At 48 hours after separators and initial arch wire placement.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Reported use of chewing gum and analgesics.
Tidsramme: Immediately after the separator and archwire placements until up to 6 hours
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Amount of chewing gums and medications consumed after the separator and initial arch wire placement
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Immediately after the separator and archwire placements until up to 6 hours
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Reported use of chewing gum and analgesics.
Tidsramme: from 6 hours to 24 hours after the separator and archwire placements
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Amount of chewing gums and medications consumed after the separator and initial arch wire placement
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from 6 hours to 24 hours after the separator and archwire placements
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Reported use of chewing gum and analgesics.
Tidsramme: from 24 hours to 48 hours after the separator and archwire placements
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Amount of chewing gums and medications consumed after the separator and initial arch wire placement
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from 24 hours to 48 hours after the separator and archwire placements
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Recorded appliances breakages.
Tidsramme: Immediately after the separator and archwire placements until 2 days after the separator and archwire placement
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Frequency of appliances breakages
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Immediately after the separator and archwire placements until 2 days after the separator and archwire placement
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Siti Adibah Othman, Prof, Faculty Of Dentistry, University of Malaya
- Studieleder: Zamros Yuzadi Mohd Yusof, Prof, Faculty Of Dentistry, University of Malaya
- Hovedetterforsker: Poon Pei San, Faculty Of Dentistry, University of Malaya
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Salmassian R, Oesterle LJ, Shellhart WC, Newman SM. Comparison of the efficacy of ibuprofen and acetaminophen in controlling pain after orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 2009 Apr;135(4):516-21. doi: 10.1016/j.ajodo.2007.05.020.
- Benson PE, Razi RM, Al-Bloushi RJ. The effect of chewing gum on the impact, pain and breakages associated with fixed orthodontic appliances: a randomized clinical trial. Orthod Craniofac Res. 2012 Aug;15(3):178-87. doi: 10.1111/j.1601-6343.2012.01546.x. Epub 2012 Jun 22.
- Ireland AJ, Ellis P, Jordan A, Bradley R, Ewings P, Atack NE, Griffiths H, House K, Moore M, Deacon S, Wenger N, Worth V, Scaysbrook E, Sandy JR. Comparative assessment of chewing gum and ibuprofen in the management of orthodontic pain with fixed appliances: A pragmatic multicenter randomized controlled trial. Am J Orthod Dentofacial Orthop. 2016 Aug;150(2):220-7. doi: 10.1016/j.ajodo.2016.02.018.
- Kehoe MJ, Cohen SM, Zarrinnia K, Cowan A. The effect of acetaminophen, ibuprofen, and misoprostol on prostaglandin E2 synthesis and the degree and rate of orthodontic tooth movement. Angle Orthod. 1996;66(5):339-49. doi: 10.1043/0003-3219(1996)0662.3.CO;2.
- Xiaoting L, Yin T, Yangxi C. Interventions for pain during fixed orthodontic appliance therapy. A systematic review. Angle Orthod. 2010 Sep;80(5):925-32. doi: 10.2319/010410-10.1.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
6. mars 2019
Primær fullføring (Forventet)
1. august 2021
Studiet fullført (Forventet)
1. august 2021
Datoer for studieregistrering
Først innsendt
5. november 2020
Først innsendt som oppfylte QC-kriteriene
5. april 2021
Først lagt ut (Faktiske)
8. april 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. april 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. april 2021
Sist bekreftet
1. april 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- DGD170001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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