Dental MalocclusionNCT06278116
Comparison of Absorbance Values, Sensory Evaluations and Periodontal Effects of Five Different Products for Clean Aligners Cleansing
A study testing Aligners cleansing with water, Aligners cleansing with dish soap Svelto and Aligners cleansing with Polident Antibacterial Denture Cleaner in people with Dental Malocclusion, run by University of Pavia at 1 site in Italy.
Trial summary
The aim of the study is to evaluate the most efficient product for the cleaning of Invisalign® clear aligners (Align Technology Inc., San Jose, CA, USA) through objective and subjective assessments after the use of 5 different products. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Malocclusion
- What is being tested?
- Aligners cleansing with water, Aligners cleansing with dish soap Svelto and Aligners cleansing with Polident Antibacterial Denture Cleaner
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2024to 30 Jul 2024
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing orthodontic treatment with Invisalign® clear aligners.
Who cannot join
- Failing to follow cleaning method instructions
- Failing to fill in the questionnaires
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: Comparison of Absorbance Values, Sensory Evaluations and Periodontal Effects of Five Different Products for Clean Aligners Cleansing: Randomized Clinical Trial
The aim of the study is to evaluate the most efficient product for the cleaning of Invisalign® clear aligners (Align Technology Inc., San Jose, CA, USA) through objective and subjective assessments after the use of 5 different products. For each aligner, one product is used for 2 weeks until all of them are used, therefore 5 different aligners are required for the study. A periodontal evaluation is conducted to assess variations during the time frame of the study.
Read the detailed description
This randomized clinical trial aims to evaluate the efficacy of 5 different products for the cleansing of Invisalign® clear aligners among the followings:
- drinking water;
- dish soap Svelto (Unilever Italia Mkt operations S.r.l.; Roma, IT);
- Polident Antibacterial Denture Cleaner (GlaxoSmithKline; Philadelphia, Pa, USA);
- Cleaning Crystals Invisalign® (Align Technology, Inc.; San Jose, CA, USA);
- Geldis (Kalipharm S.r.l., Alba, IT).
Patients that will sign the informed consent will be enrolled for the study; parents will sign the consent for underage patients.
2 week before the beginning of the orthodontic treatment with Invisalign clear aligners, a professional manual and mechanical removal of supragingival and subgingival deposits of both arches will be performed. At the baseline (T0), the first aligner will be delivered to the patient, that must wear it for 22/24 h except for meals and oral hygiene procedures. One of the 5 cleaning product will be randomly assigned to the patient and toothbrush with silicone bristles (Kalipharm S.r.l., Alba, IT) will be given the cleaning procedures. Patients will be asked to fill in a questionnaire for the subjective appreciation on the cleaning material: the questionnaire presents 19 items evaluating organoleptic and visual characteristics of the aligners and the ease of use of the cleaning method after the first use, after 1 and after 2 weeks. After 2 weeks (T1), patient will be visited again: the questionnaire will be collected, together with the aligner, and a periodontal evaluation on the Ramfjiord teeth will be performed using the following indices: Plaque Index (PI), Bleeding on Probing (BoP), Probing Pocket Depth (PPD), (Gingival Index), BEWE (Basic Erosive Wear Examination), Schiff Air Index. After that, another questionnaire and the following aligner will be given to the patient, another cleaning product will be randomly assigned and another toothbrush will be given. The procedure will be repeated for the following 2 (T2), 4 (T3), 6 (T4) and 8 weeks (T5) until all the cleaning products are tested. All the products will be masked.
JASCO V-750 spectrophotometer (Jasco Corporation, Tokyo, Japan) will be used to evaluate adsorbance for each aligner after the application of the cleaning products. A control value will be calculated using a new clean aligner. The spectrophotometer calculates reflectance values that will be converted in adsorbance values.
Sample size
Sample size was calculated with the following assumptions: ability to detect a clinically relevant difference of 0.0265 in the adsorbance of the clear aligner (primary outcome) of the five groups with an alfa = 0.05 and power = 80%. The assumptions were based on findings of a previous study, with an expected value of 0.190 and a standard deviation of 0.03 for the first group after 2 weeks. Therefore, 20 aligners per each cleaning method were required for the study.
Statistical analysis Statistical analysis will be conducted with R software (R version 3.1.3, R Development Core Team, R Foundation for Statistical Computing, Wien, Austria).
For each variable, Significance for all statistical tests will be predetermined at P<0.05.
- Conditions
- Dental Malocclusion
- Being tested
- Aligners cleansing with water, Aligners cleansing with dish soap Svelto, Aligners cleansing with Polident Antibacterial Denture Cleaner, Aligners cleansing with Invisalign Cleaning Crystals, Aligners cleansing with Geldis
- Keywords
- clear aligners
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aligners cleansing with waterOther
The product is masked in a spraying bottle without any labels. Once a day, for 14 days, the patient sprays the product on the aligner before cleaning it with a soft bristle toothbrush for 1 minute. Afterward, the aligner is rinsed under fresh running water.
Aligners cleansing with dish soap SveltoOther
the product is masked in a transparent bottle without any labels. Once a day, for 14 days, the patient puts the product on the aligner before cleaning it with a soft bristle toothbrush for 1 minute. Afterward, the aligner is rinsed under fresh running water.
Aligners cleansing with Polident Antibacterial Denture CleanerOther
the product is masked by deleting all labels on the packaging with a black permanent marker. Once a day, for 14 days, the patient dissolves the tablet in a glass full of warm water (30-35 °C), then the aligner is placed inside it for 5 minutes. Afterward the aligner is rinsed under fresh running water.
Aligners cleansing with Invisalign Cleaning CrystalsOther
the product is masked by deleting all labels on the packaging with a black permanent marker. Once a day, for 14 days, the patient dissolves the crystals in a glass full of warm water (30-35 °C) mixing with a spoon for 20 seconds; then, the aligner is placed inside the glass for 15 minutes. Afterward, the aligner is rinsed under fresh running water.
Aligners cleansing with GeldisOther
the product is masked by deleting all labels on the packaging with a black permanent marker. Once a day, for 14 days, the patient puts the product on the aligner before cleaning it with a soft toothbrush for 1 minute. Afterward, the aligner is rinsed under fresh running water.
| Study group | Role | What they receive |
|---|---|---|
| Water | Active comparator | Not described Receives: Other: Aligners cleansing with water |
| Dish soap | Active comparator | Not described Receives: Other: Aligners cleansing with dish soap Svelto |
| Polident Antibacterial Denture Cleaner® | Active comparator | Not described Receives: Other: Aligners cleansing with Polident Antibacterial Denture Cleaner |
| Invisalign Cleaning Crystals® | Active comparator | Not described Receives: Other: Aligners cleansing with Invisalign Cleaning Crystals |
| Geldis® | Active comparator | Not described Receives: Other: Aligners cleansing with Geldis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adsorbance (A) value
The changes in adsorbance values evaluated with a spectrophotometer.
Measured: Baseline (T0) and after 14 days from baseline (T1)
Changes in patient's perception
Through a questionnaire, a subjective evaluation is carried out as regards:
- the patient's perception of the ease of use of the five products;
- the difference perceived by the patient in terms of subjective changes in color, smell, taste, cleanness and tactile sensation after the first use, after a week and after 2 weeks of the cleaning method.
For each of the 19 questions, a mark from 0 (worse mark) to 10 (best mark) will be provided.
Measured: Baseline (T0) and after 14 days from baseline (T1)
Secondary outcomes (6)
Changes in Probing Pocket Depth (PPD) values
PPD is evaluated with a periodontal probe on the facial and lingual surfaces of the Ramfjord teeth in three sites: distal, central and mesial.
Measured: Baseline (T0) and after 14 days from baseline (T1)
Changes in Gingival Index (GI) values
Site-specific assessment of the presence or absence of gingival inflammation.
Scoring criteria:
- 0: absence of inflammation;
- 1: mild inflammation;
- 2: moderate inflammation;
- 3: severe inflammation.
Measured: Baseline (T0) and after 14 days from baseline (T1)
Changes in Bleeding on probing (BOP)
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 4 sites (mesial, distal, vestibular, palatal/lingual).
Measured: Baseline (T0) and after 14 days from baseline (T1)
Change in Schiff Air Index - Dental sensitivity test
Scoring criteria:
- 0: the subject did not respond to air blasting;
- 1: the subject responded to air blasting;
- 2: the subject responded to air blasting and requested discontinuation;
- 3: the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful.
Measured: Baseline (T0) and after 14 days from baseline (T1)
Change of the BEWE Index Basic Erosive Wear Examination
Scoring criteria:
- 0: no erosive tooth wear;
- 1: initial loss of surface texture;
- 2: distinct defect, hard tissue loss < 50% of the surface area;
- 3: hard tissue loss ≥ 50% of the surface area.
Measured: Baseline (T0) and after 14 days from baseline (T1)
Change in plaque index (PI):
Site specific assessment of the amount of plaque on dental surfaces; it is detected on facial and lingual surfaces of the Ramfjord teeth.
Scoring criteria:
- 0: absence of plaque;
- 1: plaque revealed on probing;
- 2: visible layer of plaque on the tooth surface;
- 3: abundant plaque on tooth surface. Results indicate the index as a percentage.
Measured: Baseline (T0) and after 14 days from baseline (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Mar 2024
- Primary completion28 Jul 2024
- Study completion30 Jul 2024
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 Dental MalocclusionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278116
- Sponsor's protocol ID
- 2024-ALIGNERSCLEANSIGN
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2024
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the Principal Investigator.
Publications
Sfondrini MF, Nardi MG, Pascadopoli M, Alberti G, Scribante A. Spectrophotometric, Periodontal and Subjective Evaluations on Five Different Products for Clear Aligners Cleansing: Randomised Clinical Trial. Int J Dent. 2026 Jul 1;2026:9974833. doi: 10.1155/ijod/9974833. eCollection 2026.
PubMed 42396375
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Absorbance Values, Sensory Evaluations and Periodontal Effects of Five Different Products for Clean Aligners Cleansing: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06278116
- Acronym / sponsor ID
- 2024-ALIGNERSCLEANSIGN
- Conditions
- Dental Malocclusion
- Keywords
- clear aligners
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 28 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 26 Feb 2024 (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 aim of the study is to evaluate the most efficient product for the cleaning of Invisalign® clear aligners (Align Technology Inc., San Jose, CA, USA) through objective and subjective assessments after the use of 5 different products. For each aligner, one product is used for 2 weeks until all of them are used, therefore 5 different aligners are required for the study. A periodontal evaluation is conducted to assess variations during the time frame of the study.
Detailed description
This randomized clinical trial aims to evaluate the efficacy of 5 different products for the cleansing of Invisalign® clear aligners among the followings:
- drinking water;
- dish soap Svelto (Unilever Italia Mkt operations S.r.l.; Roma, IT);
- Polident Antibacterial Denture Cleaner (GlaxoSmithKline; Philadelphia, Pa, USA);
- Cleaning Crystals Invisalign® (Align Technology, Inc.; San Jose, CA, USA);
- Geldis (Kalipharm S.r.l., Alba, IT).
Patients that will sign the informed consent will be enrolled for the study; parents will sign the consent for underage patients.
2 week before the beginning of the orthodontic treatment with Invisalign clear aligners, a professional manual and mechanical removal of supragingival and subgingival deposits of both arches will be performed. At the baseline (T0), the first aligner will be delivered to the patient, that must wear it for 22/24 h except for meals and oral hygiene procedures. One of the 5 cleaning product will be randomly assigned to the patient and toothbrush with silicone bristles (Kalipharm S.r.l., Alba, IT) will be given the cleaning procedures. Patients will be asked to fill in a questionnaire for the subjective appreciation on the cleaning material: the questionnaire presents 19 items evaluating organoleptic and visual characteristics of the aligners and the ease of use of the cleaning method after the first use, after 1 and after 2 weeks. After 2 weeks (T1), patient will be visited again: the questionnaire will be collected, together with the aligner, and a periodontal evaluation on the Ramfjiord teeth will be performed using the following indices: Plaque Index (PI), Bleeding on Probing (BoP), Probing Pocket Depth (PPD), (Gingival Index), BEWE (Basic Erosive Wear Examination), Schiff Air Index. After that, another questionnaire and the following aligner will be given to the patient, another cleaning product will be randomly assigned and another toothbrush will be given. The procedure will be repeated for the following 2 (T2), 4 (T3), 6 (T4) and 8 weeks (T5) until all the cleaning products are tested. All the products will be masked.
JASCO V-750 spectrophotometer (Jasco Corporation, Tokyo, Japan) will be used to evaluate adsorbance for each aligner after the application of the cleaning products. A control value will be calculated using a new clean aligner. The spectrophotometer calculates reflectance values that will be converted in adsorbance values.
Sample size
Sample size was calculated with the following assumptions: ability to detect a clinically relevant difference of 0.0265 in the adsorbance of the clear aligner (primary outcome) of the five groups with an alfa = 0.05 and power = 80%. The assumptions were based on findings of a previous study, with an expected value of 0.190 and a standard deviation of 0.03 for the first group after 2 weeks. Therefore, 20 aligners per each cleaning method were required for the study.
Statistical analysis Statistical analysis will be conducted with R software (R version 3.1.3, R Development Core Team, R Foundation for Statistical Computing, Wien, Austria).
For each variable, Significance for all statistical tests will be predetermined at P<0.05.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Water | Active comparator | Other: Aligners cleansing with water |
| Dish soap | Active comparator | Other: Aligners cleansing with dish soap Svelto |
| Polident Antibacterial Denture Cleaner® | Active comparator | Other: Aligners cleansing with Polident Antibacterial Denture Cleaner |
| Invisalign Cleaning Crystals® | Active comparator | Other: Aligners cleansing with Invisalign Cleaning Crystals |
| Geldis® | Active comparator | Other: Aligners cleansing with Geldis |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing orthodontic treatment with Invisalign® clear aligners.
Key exclusion criteria (2 listed)
- Failing to follow cleaning method instructions
- Failing to fill in the questionnaires
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 |
|---|---|---|
| Aligners cleansing with waterThe product is masked in a spraying bottle without any labels. Once a day, for 14 days, the patient sprays the product on the aligner before cleaning it with a soft bristle toothbrush for 1 minute. Afterward, the aligner is rinsed under fresh running water. | Other | Water |
| Aligners cleansing with dish soap Sveltothe product is masked in a transparent bottle without any labels. Once a day, for 14 days, the patient puts the product on the aligner before cleaning it with a soft bristle toothbrush for 1 minute. Afterward, the aligner is rinsed under fresh running water. | Other | Dish soap |
| Aligners cleansing with Polident Antibacterial Denture Cleanerthe product is masked by deleting all labels on the packaging with a black permanent marker. Once a day, for 14 days, the patient dissolves the tablet in a glass full of warm water (30-35 °C), then the aligner is placed inside it for 5 minutes. Afterward the aligner is rinsed under fresh running water. | Other | Polident Antibacterial Denture Cleaner® |
| Aligners cleansing with Invisalign Cleaning Crystalsthe product is masked by deleting all labels on the packaging with a black permanent marker. Once a day, for 14 days, the patient dissolves the crystals in a glass full of warm water (30-35 °C) mixing with a spoon for 20 seconds; then, the aligner is placed inside the glass for 15 minutes. Afterward, the aligner is rinsed under fresh running water. | Other | Invisalign Cleaning Crystals® |
| Aligners cleansing with Geldisthe product is masked by deleting all labels on the packaging with a black permanent marker. Once a day, for 14 days, the patient puts the product on the aligner before cleaning it with a soft toothbrush for 1 minute. Afterward, the aligner is rinsed under fresh running water. | Other | Geldis® |
Primary outcome
Change in adsorbance (A) value
Time frame: Baseline (T0) and after 14 days from baseline (T1)
The changes in adsorbance values evaluated with a spectrophotometer.
Changes in patient's perception
Time frame: Baseline (T0) and after 14 days from baseline (T1)
Through a questionnaire, a subjective evaluation is carried out as regards: * the patient's perception of the ease of use of the five products; * the difference perceived by the patient in terms of subjective changes in color, smell, taste, cleanness and tactile sensation after the first use, after a week and after 2 weeks of the cleaning method. For each of the 19 questions, a mark from 0 (worse mark) to 10 (best mark) will be provided.
6 secondary outcomes
Changes in Probing Pocket Depth (PPD) values
Time frame: Baseline (T0) and after 14 days from baseline (T1)
Changes in Gingival Index (GI) values
Time frame: Baseline (T0) and after 14 days from baseline (T1)
Changes in Bleeding on probing (BOP)
Time frame: Baseline (T0) and after 14 days from baseline (T1)
Change in Schiff Air Index - Dental sensitivity test
Time frame: Baseline (T0) and after 14 days from baseline (T1)
Change of the BEWE Index Basic Erosive Wear Examination
Time frame: Baseline (T0) and after 14 days from baseline (T1)
Change in plaque index (PI):
Time frame: Baseline (T0) and after 14 days from baseline (T1)
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 4 Feb 2026.
- Derived from this study: PubMed 42396375Sfondrini MF, Nardi MG, Pascadopoli M, Alberti G, Scribante A. Spectrophotometric, Periodontal and Subjective Evaluations on Five Different Products for Clear Aligners Cleansing: Randomised Clinical Trial. Int J Dent. 2026 Jul 1;2026:9974833. doi: 10.1155/ijod/9974833. eCollection 2026.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the Principal Investigator.
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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.
Andrea Scribante, DDS, PhD principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aligners cleansing with water, Aligners cleansing with dish soap Svelto and Aligners cleansing with Polident Antibacterial Denture Cleaner in people with Dental Malocclusion, run by University of Pavia at 1 site in Italy.
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 2 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 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 adsorbance (A) value (time frame: Baseline (T0) and after 14 days from baseline (T1)). The study lists 2 primary outcomes in all. 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 NCT06278116, 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 4 Feb 2026.