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Can Surface Roughness Predict Progression of Tooth Wear?

5. juni 2017 oppdatert av: King's College London

Can Surface Roughness Predict Progression of Tooth Wear in Participants With Dietary Origins of Acid?

The clinical study was a single-blind, randomised intervention study to measure surface changes of polished and unpolished enamel in situ following an orange juice acid challenge. Ethical approval for the study was granted by the Stanmore Health Research Authority REC ref 15/LO/0417, and the study was conducted per the guidelines for Good Clinical Practice. The study investigated a total 6 erosion regimes divided in 3 different erosion times plus ex vivo immersion in orange juice drink versus in vivo rinsing of the same orange juice drink.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

60 unpolished and 60 polished enamel samples were prepared from extracted human molars collected under ethical approval.

30 healthy volunteers were recruited and lower dental impressions were recorded using standard stock trays. Custom made lower orthoodontic type appliances were made by the laboratory to accommodate a total of four enamel (2 left and right hand side) samples positioned buccally in the premolar/molar region.

The volunteers were randomly allocated into one of 3 groups: 5 mins erosion repeated x3, 10 mins erosion repeated x3 or 15 mins erosion repeated x3 and a coin was flipped to determine which side the samples were to be removed for ex vivo immersion with tails for left and heads for right. . At the beginning of the study visit the splints were inserted and worn for 30 minutes. Following which the enamel samples (1 polished and 1 unpolished) were removed from one side to begin the erosion regime. For in vivo erosion each participant was asked to rinse with orange juice for their either time 5, 10 or 15 minutes. This was standardised by setting up cups with 10 mL of the orange juice and a timer set at 1 minute. The participant was asked to insert the liquid into their mouths start the time and when the alarm sounded expectorate and repeat until they completed his/her time allocation of either 5, 10 or 15 minutes. Simultaneously the ex vivo samples were immersed in 20 mL of orange juice and agitated at 62 rpm for the allocated time using an orbital shaker (Stuart Scientific, Mini Orbital Shaker S05, Bibby). This completed one cycle after which the removed samples were reinserted into the splint which was worn for a further hour after which the rinsing/immersion regime was repeated. The process was repeated a further instance to complete 3 cycles of erosion. After the 3rd and final erosion cycle the participants were given a desensitising toothpaste Sensodyne Repair & Protect (GSK, Weybridge, UK).

The unpolished enamel samples were analysed before and after the experiment to measure changes in surface texture. Whereas, the polished samples were analysed for surface texture, hardness change and tissue loss.

Studietype

Intervensjonell

Registrering (Faktiske)

30

Fase

  • Ikke aktuelt

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • mild erosive tooth wear maximum score of 2 in each sextant and cumulative score no more than 8, aged 18 years and over, willing to participate, not enrolled in any other research, more than 20 anterior and posterior teeth, no active carious lesions and a maximum BPE score of 2 in one sextant (no periodontal disease).

Exclusion Criteria:

  • pregnancy or breast feeding, medical history likely to impact on attendance or mobility, insulin dependent diabetes, saliva diagnoses (xerostomia), lower orthodontic appliances, dentine hypersensitivity, defective restoration of the occlusal or incisal surfaces of upper anterior teeth and first molars and any condition that precluded consumption of 300 ml of orange juice a day for 5 consecutive days.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 15 minutes' erosion
Orange juice is administered ex vivo and in vivo for 5 minutes and repeated a total of 3 times
3 immersion times in orange juice were investigated
Eksperimentell: 30 minutes' erosion
Orange juice is administered ex vivo and in vivo for 10 minutes and repeated a total of 3 times
3 immersion times in orange juice were investigated
Eksperimentell: 45 minutes' erosion
Orange juice is administered ex vivo and in vivo for 15 minutes and repeated a total of 3 times
3 immersion times in orange juice were investigated

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Microhardness (KHN)
Tidsramme: 12 weeks
To measure microhardness of enamel samples using a microhardness tester before and after the intervention. The units will be KHN
12 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Surface roughness
Tidsramme: 12 weeks
To measure surface roughness of enamel samples using anon contact profilometer before and after the intervention. The units will be microns.
12 weeks
Step height loss
Tidsramme: 12 weeks
To measure step height loss of enamel samples following the intervention using a non contact profilometer. The units will be microns.
12 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

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.

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)

10. januar 2017

Primær fullføring (Faktiske)

29. mai 2017

Studiet fullført (Faktiske)

29. mai 2017

Datoer for studieregistrering

Først innsendt

30. mai 2017

Først innsendt som oppfylte QC-kriteriene

5. juni 2017

Først lagt ut (Faktiske)

7. juni 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. juni 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. juni 2017

Sist bekreftet

1. mai 2017

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 15/LO/0417

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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