Can Surface Roughness Predict Progression of Tooth Wear?

NCT03178968 | Completed

• 1 other identifier: 15/LO/0417
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Tooth Wear

Outcome Measures

Primary Outcomes (1)

• Microhardness (KHN)

  To measure microhardness of enamel samples using a microhardness tester before and after the intervention. The units will be KHN

  12 weeks

Secondary Outcomes (2)

• Surface roughness

  12 weeks

• Step height loss

  12 weeks

Study Arms (3)

15 minutes' erosion

EXPERIMENTAL

Orange juice is administered ex vivo and in vivo for 5 minutes and repeated a total of 3 times

Other: Orange juice

30 minutes' erosion

EXPERIMENTAL

Orange juice is administered ex vivo and in vivo for 10 minutes and repeated a total of 3 times

Other: Orange juice

45 minutes' erosion

EXPERIMENTAL

Orange juice is administered ex vivo and in vivo for 15 minutes and repeated a total of 3 times

Other: Orange juice

Interventions

Orange juice OTHER

3 immersion times in orange juice were investigated

15 minutes' erosion; 30 minutes' erosion; 45 minutes' erosion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• GlaxoSmithKline: collaborator

Related Publications (1)

• Mullan F, Austin RS, Parkinson CR, Bartlett DW. An in-situ pilot study to investigate the native clinical resistance of enamel to erosion. J Dent. 2018 Mar;70:124-128. doi: 10.1016/j.jdent.2018.01.005. Epub 2018 Jan 12.

  PMID: 29339202 DERIVED

MeSH Terms

Conditions

Tooth Wear

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single-blind, randomised intervention study (blinded for the surface roughness measurements, step height measurements and microhardness testing)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 7, 2017
• Study Start: January 10, 2017
• Primary Completion: May 29, 2017
• Study Completion: May 29, 2017
• Last Updated: June 7, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share