Dental ErosionNCT07690644
Quantitative In Vivo Monitoring of Early Erosion-Associated Enamel Optical Changes Using Swept-Source Optical Coherence Tomography.
A study testing Swept-Source Optical Coherence Tomography (SS-OCT), Orange Juice Erosive Challenge and Sugar-Free Chewing Gum Stimulation in people with Dental Erosion and Erosive Tooth Wear, run by University of Malaya.
Trial summary
This study aims to evaluate the ability of swept-source optical coherence tomography (SS-OCT) to detect early enamel optical changes associated with erosive tooth wear under clinically relevant in vivo conditions. Read more about this study
- Who is it for?
- Ages 22 to 33 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Erosion, Erosive Tooth Wear
- What is being tested?
- Swept-Source Optical Coherence Tomography (SS-OCT), Orange Juice Erosive Challenge and Sugar-Free Chewing Gum Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 21 Jun 2016to 30 Jun 2016
- 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 22 to 33 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 23-33 years. Presence of intact maxillary right central incisor (tooth 11) suitable for repeated SS-OCT imaging.
- Good general and oral health. Normal unstimulated salivary flow rate (≥0.2 mL/min). Willingness to comply with all study procedures, including repeated erosive challenges and SS-OCT examinations.
- Provision of written informed consent prior to participation.-
Who cannot join
- Presence of active dental caries, restorations, enamel defects, cracks, or erosive lesions on the study tooth.
- Ongoing orthodontic treatment affecting the study tooth. History of systemic diseases or medications known to affect salivary flow or enamel mineralization.
- Unstimulated salivary flow rate <0.2 mL/min. Pregnancy or breastfeeding. Known allergy or intolerance to orange juice or sugar-free chewing gum. Current smokers or tobacco users. Inability or unwillingness to comply with study procedures or attend all scheduled visits.
About this study
This study aims to evaluate the ability of swept-source optical coherence tomography (SS-OCT) to detect early enamel optical changes associated with erosive tooth wear under clinically relevant in vivo conditions. The study also investigates whether salivary stimulation induced by sugar-free chewing gum influences enamel optical properties following repeated erosive challenges.
A prospective, longitudinal, within-subject study with a fixed-sequence design was conducted. Twenty-two healthy adults aged 23-33 years participated after meeting predefined inclusion and exclusion criteria. All participants completed two sequential experimental phases separated by a two-day washout period. A fixed-order design (Phase A followed by Phase B) was selected to standardize erosive exposure and minimize variability during repeated intraoral OCT measurements. As an exploratory study, randomization was not performed.
Read more
In both phases, participants underwent repeated erosive challenges using commercially available orange juice (pH 3.4). During each challenge, participants swished 25 mL of orange juice for 30 seconds followed by a 30-second rest interval, repeated continuously for 10 minutes (total exposure: 250 mL). Erosive challenges were performed three times daily at three-hour intervals over three consecutive days under investigator supervision.
Phase A consisted of repeated erosive challenges without intervention. In Phase B, participants followed the identical erosive protocol but chewed sugar-free chewing gum for 15 minutes immediately after each erosive challenge to stimulate salivary flow and enhance natural buffering and remineralization mechanisms.
All participants used standardized fluoridated toothpaste and soft-bristled toothbrushes beginning two days before the study and throughout the experimental period. Unstimulated salivary flow rate was measured before enrolment, and participants with salivary flow rates below 0.2 mL/min were excluded.
The primary outcome measure was enamel integrated reflectivity (IR), quantified from SS-OCT A-scan analysis as an indicator of enamel optical changes associated with early demineralization. A commercially available swept-source OCT system equipped with an intraoral probe was used for image acquisition. The middle third of the labial surface of the maxillary right central incisor (tooth 11) served as the standardized imaging site. Custom acrylic positioning devices and anatomical landmarks were used to improve reproducibility of repeated measurements.
SS-OCT imaging was performed at six standardized time points during each study day: baseline before the first erosive challenge (t1), after the first challenge (t2), after the second challenge (t3), after the third challenge (t4), following a three-hour rest period (t5), and the following morning after overnight salivary exposure (t6). Image acquisition parameters, drying procedures, and positioning were standardized for all participants.
Integrated reflectivity values were calculated from predefined regions of interest using established OCT image analysis methods. Five adjacent A-scans were averaged to reduce signal noise. Statistical analyses included paired sample t-tests for predefined comparisons and linear mixed-effects modelling to evaluate longitudinal changes while accounting for repeated measurements within participants. Statistical significance was set at α = 0.05.
The study was approved by the appropriate institutional ethics committee, and written informed consent was obtained from all participants before enrolment. The study complied with the principles of the Declaration of Helsinki. Findings are expected to provide evidence regarding the feasibility of SS-OCT as a non-invasive clinical tool for monitoring early erosive enamel changes and evaluating preventive interventions under clinically relevant oral conditions.
- Conditions
- Dental Erosion, Erosive Tooth Wear
- Being tested
- Swept-Source Optical Coherence Tomography (SS-OCT), Orange Juice Erosive Challenge, Sugar-Free Chewing Gum Stimulation
- Keywords
- Dental erosion, Erosive tooth wear, Swept-source optical coherence tomography (SS-OCT), Enamel demineralization, Integrated reflectivity, Non-invasive imaging, Salivary stimulation, In vivo longitudinal study
- Medical subject headings
- Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swept-Source Optical Coherence Tomography (SS-OCT)Diagnostic test
A commercially available swept-source optical coherence tomography (SS-OCT) system (OCS1300SS, Thorlabs Inc., USA) equipped with an intraoral probe was used to obtain non-invasive cross-sectional images of enamel. The labial surface of the maxillary right central incisor was imaged under standardized conditions at six time points per day during each 3-day experimental phase to quantify enamel integrated reflectivity.
Orange Juice Erosive ChallengeOther
Participants swished 25 mL of commercially available orange juice (pH 3.4) for 30 seconds followed by a 30-second rest interval. This cycle was repeated continuously for 10 minutes (total exposure: 250 mL per session). The erosive challenge was performed three times daily at 3-hour intervals for three consecutive days during both experimental phases.
Sugar-Free Chewing Gum StimulationBehavioural
During Phase B, participants chewed one piece of sugar-free chewing gum (Wrigley's Extra® Peppermint) for 15 minutes immediately after each orange juice erosive challenge to stimulate salivary flow. This intervention was repeated after each of the three daily erosive challenge sessions over three consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Repeated Erosive Challenge With and Without Chewing Gum Stimulation | Experimental | Participants underwent two sequential experimental phases in a fixed-order design. During Phase A, participants received repeated orange juice erosive challenges without chewing gum stimulation for three consecutive days. Following a two-day washout period, all participants completed Phase B, during which the identical erosive challenge protocol was repeated with 15 minutes of sugar-free chewing gum immediately after each erosive challenge. Swept-source optical coherence tomography (SS-OCT) imaging was performed repeatedly throughout both phases to monitor enamel optical changes. Each participant served as his or her own control. Receives: Diagnostic Test: Swept-Source Optical Coherence Tomography (SS-OCT); Other: Orange Juice Erosive Challenge; Behavioral: Sugar-Free Chewing Gum Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in enamel integrated reflectivity measured by swept-source optical coherence tomography (SS-OCT)
Description
Integrated reflectivity (IR), derived from SS-OCT A-scan analysis, will be used to quantify changes in enamel backscattered light intensity associated with early erosion-related optical alterations. Higher IR values indicate increased optical scattering consistent with enamel demineralization.
Measured: Baseline through Day 3 of each study phase (6 measurements per day over two 3-day experimental phases).
Secondary outcomes (1)
Longitudinal changes in enamel integrated reflectivity during repeated erosive challenges
Longitudinal changes in integrated reflectivity will be evaluated using repeated SS-OCT measurements and linear mixed-effects modelling to assess cumulative enamel optical changes over time and between experimental phases.
Measured: Baseline through Day 3 of each experimental phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start21 Jun 2016
- Primary completion24 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ErosionStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This was a single-group, longitudinal interventional study in which all participants underwent the same sequence of two experimental phases. In Phase A, participants received repeated orange juice erosive challenges without chewing gum stimulation for three consecutive days. Following a two-day washout period, all participants completed Phase B, during which the identical erosive challenge protocol was repeated with 15 minutes of sugar-free chewing gum immediately after each erosive challenge. Each participant served as his or her own control. The fixed-sequence design was selected to standardize erosive exposure and repeated SS-OCT imaging conditions and to minimize measurement variability in this exploratory study.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azwatee binti Abdul Aziz, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690644
- Sponsor's protocol ID
- Ethics: DF RD1617/0054(P)
- Other IDs
- UM-MOHE HIR Grant UM.C/HIR/MOH
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Do not intend to make de-identified individual participant data publicly available. The ethics approval and participant consent did not include provisions for sharing individual participant data. Data will only be available upon reasonable request or not at all.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative In Vivo Monitoring of Early Erosion-Associated Enamel Optical Changes Using Swept-Source Optical Coherence Tomography.
- ClinicalTrials.gov ID
- NCT07690644
- Acronym / sponsor ID
- Ethics: DF RD1617/0054(P)
- Conditions
- Dental Erosion, Erosive Tooth Wear
- Keywords
- Dental erosion, Erosive tooth wear, Swept-source optical coherence tomography (SS-OCT), Enamel demineralization, Integrated reflectivity, Non-invasive imaging, Salivary stimulation, In vivo longitudinal study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 21 Jun 2016 (actual)
- Primary completion
- 24 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 8 Jul 2026 (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.
This study aims to evaluate the ability of swept-source optical coherence tomography (SS-OCT) to detect early enamel optical changes associated with erosive tooth wear under clinically relevant in vivo conditions. The study also investigates whether salivary stimulation induced by sugar-free chewing gum influences enamel optical properties following repeated erosive challenges.
A prospective, longitudinal, within-subject study with a fixed-sequence design was conducted. Twenty-two healthy adults aged 23-33 years participated after meeting predefined inclusion and exclusion criteria. All participants completed two sequential experimental phases separated by a two-day washout period. A fixed-order design (Phase A followed by Phase B) was selected to standardize erosive exposure and minimize variability during repeated intraoral OCT measurements. As an exploratory study, randomization was not performed.
In both phases, participants underwent repeated erosive challenges using commercially available orange juice (pH 3.4). During each challenge, participants swished 25 mL of orange juice for 30 seconds followed by a 30-second rest interval, repeated continuously for 10 minutes (total exposure: 250 mL). Erosive challenges were performed three times daily at three-hour intervals over three consecutive days under investigator supervision.
Phase A consisted of repeated erosive challenges without intervention. In Phase B, participants followed the identical erosive protocol but chewed sugar-free chewing gum for 15 minutes immediately after each erosive challenge to stimulate salivary flow and enhance natural buffering and remineralization mechanisms.
All participants used standardized fluoridated toothpaste and soft-bristled toothbrushes beginning two days before the study and throughout the experimental period. Unstimulated salivary flow rate was measured before enrolment, and participants with salivary flow rates below 0.2 mL/min were excluded.
The primary outcome measure was enamel integrated reflectivity (IR), quantified from SS-OCT A-scan analysis as an indicator of enamel optical changes associated with early demineralization. A commercially available swept-source OCT system equipped with an intraoral probe was used for image acquisition. The middle third of the labial surface of the maxillary right central incisor (tooth 11) served as the standardized imaging site. Custom acrylic positioning devices and anatomical landmarks were used to improve reproducibility of repeated measurements.
SS-OCT imaging was performed at six standardized time points during each study day: baseline before the first erosive challenge (t1), after the first challenge (t2), after the second challenge (t3), after the third challenge (t4), following a three-hour rest period (t5), and the following morning after overnight salivary exposure (t6). Image acquisition parameters, drying procedures, and positioning were standardized for all participants.
Integrated reflectivity values were calculated from predefined regions of interest using established OCT image analysis methods. Five adjacent A-scans were averaged to reduce signal noise. Statistical analyses included paired sample t-tests for predefined comparisons and linear mixed-effects modelling to evaluate longitudinal changes while accounting for repeated measurements within participants. Statistical significance was set at α = 0.05.
The study was approved by the appropriate institutional ethics committee, and written informed consent was obtained from all participants before enrolment. The study complied with the principles of the Declaration of Helsinki. Findings are expected to provide evidence regarding the feasibility of SS-OCT as a non-invasive clinical tool for monitoring early erosive enamel changes and evaluating preventive interventions under clinically relevant oral conditions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This was a single-group, longitudinal interventional study in which all participants underwent the same sequence of two experimental phases. In Phase A, participants received repeated orange juice erosive challenges without chewing gum stimulation for three consecutive days. Following a two-day washout period, all participants completed Phase B, during which the identical erosive challenge protocol was repeated with 15 minutes of sugar-free chewing gum immediately after each erosive challenge. Each participant served as his or her own control. The fixed-sequence design was selected to standardize erosive exposure and repeated SS-OCT imaging conditions and to minimize measurement variability in this exploratory study.
| Arm | Type | Receives |
|---|---|---|
| Repeated Erosive Challenge With and Without Chewing Gum Stimulation | Experimental | Diagnostic Test: Swept-Source Optical Coherence Tomography (SS-OCT), Other: Orange Juice Erosive Challenge, Behavioral: Sugar-Free Chewing Gum StimulationParticipants underwent two sequential experimental phases in a fixed-order design. During Phase A, participants received repeated orange juice erosive challenges without chewing gum stimulation for three consecutive days. Following a two-day washout period, all participants completed Phase B, during which the identical erosive challenge protocol was repeated with 15 minutes of sugar-free chewing gum immediately after each erosive challenge. Swept-source optical coherence tomography (SS-OCT) imaging was performed repeatedly throughout both phases to monitor enamel optical changes. Each participant served as his or her own control. |
Who may qualify
- Ages
- 22 to 33 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults aged 23-33 years. Presence of intact maxillary right central incisor (tooth 11) suitable for repeated SS-OCT imaging.
- Good general and oral health. Normal unstimulated salivary flow rate (≥0.2 mL/min). Willingness to comply with all study procedures, including repeated erosive challenges and SS-OCT examinations.
- Provision of written informed consent prior to participation.-
Key exclusion criteria (3 listed)
- Presence of active dental caries, restorations, enamel defects, cracks, or erosive lesions on the study tooth.
- Ongoing orthodontic treatment affecting the study tooth. History of systemic diseases or medications known to affect salivary flow or enamel mineralization.
- Unstimulated salivary flow rate <0.2 mL/min. Pregnancy or breastfeeding. Known allergy or intolerance to orange juice or sugar-free chewing gum. Current smokers or tobacco users. Inability or unwillingness to comply with study procedures or attend all scheduled visits.
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 |
|---|---|---|
| Swept-Source Optical Coherence Tomography (SS-OCT)A commercially available swept-source optical coherence tomography (SS-OCT) system (OCS1300SS, Thorlabs Inc., USA) equipped with an intraoral probe was used to obtain non-invasive cross-sectional images of enamel. The labial surface of the maxillary right central incisor was imaged under standardized conditions at six time points per day during each 3-day experimental phase to quantify enamel integrated reflectivity. | Diagnostic test | Repeated Erosive Challenge With and Without Chewing Gum Stimulation |
| Orange Juice Erosive ChallengeParticipants swished 25 mL of commercially available orange juice (pH 3.4) for 30 seconds followed by a 30-second rest interval. This cycle was repeated continuously for 10 minutes (total exposure: 250 mL per session). The erosive challenge was performed three times daily at 3-hour intervals for three consecutive days during both experimental phases. | Other | Repeated Erosive Challenge With and Without Chewing Gum Stimulation |
| Sugar-Free Chewing Gum StimulationDuring Phase B, participants chewed one piece of sugar-free chewing gum (Wrigley's Extra® Peppermint) for 15 minutes immediately after each orange juice erosive challenge to stimulate salivary flow. This intervention was repeated after each of the three daily erosive challenge sessions over three consecutive days. | Behavioural | Repeated Erosive Challenge With and Without Chewing Gum Stimulation |
Primary outcome
Change in enamel integrated reflectivity measured by swept-source optical coherence tomography (SS-OCT)
Time frame: Baseline through Day 3 of each study phase (6 measurements per day over two 3-day experimental phases).
Description Integrated reflectivity (IR), derived from SS-OCT A-scan analysis, will be used to quantify changes in enamel backscattered light intensity associated with early erosion-related optical alterations. Higher IR values indicate increased optical scattering consistent with enamel demineralization.
1 secondary outcome
Longitudinal changes in enamel integrated reflectivity during repeated erosive challenges
Time frame: Baseline through Day 3 of each experimental phase.
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 8 Jul 2026.
- Individual participant dataSharing planned: No. Do not intend to make de-identified individual participant data publicly available. The ethics approval and participant consent did not include provisions for sharing individual participant data. Data will only be available upon reasonable request or not at all.
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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 Swept-Source Optical Coherence Tomography (SS-OCT), Orange Juice Erosive Challenge and Sugar-Free Chewing Gum Stimulation in people with Dental Erosion and Erosive Tooth Wear, run by University of Malaya.
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 3 inclusion and 3 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 8 Jul 2026. 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?
Change in enamel integrated reflectivity measured by swept-source optical coherence tomography (SS-OCT) (time frame: Baseline through Day 3 of each study phase (6 measurements per day over two 3-day experimental phases).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2026.