Tooth WearNCT03178968
Can Surface Roughness Predict Progression of Tooth Wear?
A study testing Orange juice in people with Tooth Wear, run by King's College London.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Wear
- What is being tested?
- Orange juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2017to 29 May 2017
- 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
- 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).
Who cannot join
- 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.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Tooth Wear
- Being tested
- Orange juice
- Medical subject headings
- Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange juiceOther
3 immersion times in orange juice were investigated
| Study group | Role | What they receive |
|---|---|---|
| 15 minutes' erosion | Experimental | Orange juice is administered ex vivo and in vivo for 5 minutes and repeated a total of 3 times Receives: 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 Receives: 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 Receives: Other: Orange juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microhardness (KHN)
To measure microhardness of enamel samples using a microhardness tester before and after the intervention. The units will be KHN
Measured: 12 weeks
Secondary outcomes (2)
Surface roughness
To measure surface roughness of enamel samples using anon contact profilometer before and after the intervention. The units will be microns.
Measured: 12 weeks
Step height loss
To measure step height loss of enamel samples following the intervention using a non contact profilometer. The units will be microns.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start10 Jan 2017
- Primary completion29 May 2017
- Study completion29 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth WearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178968
- Sponsor's protocol ID
- 15/LO/0417
- Status last verified
- May 2017
- First submitted
- 30 May 2017
- Last updated
- 7 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29339202
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Surface Roughness Predict Progression of Tooth Wear in Participants With Dietary Origins of Acid?
- ClinicalTrials.gov ID
- NCT03178968
- Acronym / sponsor ID
- 15/LO/0417
- Conditions
- Tooth Wear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 29 May 2017 (actual)
- Study completion
- 29 May 2017 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 15 minutes' erosion | Experimental | Other: Orange juiceOrange juice is administered ex vivo and in vivo for 5 minutes and repeated a total of 3 times |
| 30 minutes' erosion | Experimental | Other: Orange juiceOrange juice is administered ex vivo and in vivo for 10 minutes and repeated a total of 3 times |
| 45 minutes' erosion | Experimental | Other: Orange juiceOrange juice is administered ex vivo and in vivo for 15 minutes and repeated a total of 3 times |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orange juice3 immersion times in orange juice were investigated | Other | 15 minutes' erosion, 30 minutes' erosion, 45 minutes' erosion |
Primary outcome
Microhardness (KHN)
Time frame: 12 weeks
To measure microhardness of enamel samples using a microhardness tester before and after the intervention. The units will be KHN
2 secondary outcomes
Surface roughness
Time frame: 12 weeks
Step height loss
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Derived from this study: PubMed 29339202Mullan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Orange juice in people with Tooth Wear, run by King's College London.
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 1 inclusion and 1 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 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Microhardness (KHN) (time frame: 12 weeks). 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 NCT03178968, which also lists 1 linked publication.
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 7 Jun 2017.