Maxillary Transverse DeficiencyNCT05539469
A 6-months Evaluation of Patients' Compliance and Oral Hygiene During Rapid Maxillary Expander (RME) Treatment Using "Ortodontika" Smartphone Application
A study testing Ortodontika app and Verbal instructions in people with Maxillary Transverse Deficiency, run by University of Pavia at 1 site in Italy.
Trial summary
The aim of this study is to evaluate the clinical use of the smartphone application "Ortodontika" for the compliance of orthodontic patients with Rapid Maxillary Expander (RME). Patients and parents consenting to participate in the study will sign the informed consent for their child. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Maxillary Transverse Deficiency
- What is being tested?
- Ortodontika app and Verbal instructions
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2022to 29 Jan 2025
- 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients and their parents are able or willing to give informed consent;
- patients who will begin orthopedic treatment with RME cemented on first maxillary molars and with welded vestibular tubes;
- patients undergone no previous orthopedic/orthodontic treatment;
- parents' willing to download and use Ortodontika application;
- parents possessing an Apple or Android smartphone with iOS ≥ 10.0 or Android ≥ 4.4 versions;
- smartphone provided with an internet connection.
Who cannot join
- no sectional wire appliances in the upper arches;
- no need of additional orthopedic/orthodontic appliances, also in the lower arch;
- no vestibular welded protraction hooks on RME;
- patients taking regular medications for systemic diseases that could alter periodontal conditions and pain perception (antibiotics, antibacterial mouth rinses, NSAIDS, steroids);
- siblings with previous orthopedic treatment with RME;
- parents and patients with low compliance.
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: A 6-months Evaluation of Patients' Compliance and Oral Hygiene During Rapid Maxillary Expander (RME) Treatment Using "Ortodontika" Smartphone Application: a Randomized Clinical Trial
The aim of this study is to evaluate the clinical use of the smartphone application "Ortodontika" for the compliance of orthodontic patients with Rapid Maxillary Expander (RME).
Patients and parents consenting to participate in the study will sign the informed consent for their child. At the baseline (T0), a periodontal examination will be carried out by means of a probe assessing Bleeding Index, Plaque Index and Modified Gingival Index on upper first incisors, first premolars/first primary molars and first molars. A professional oral hygiene will be performed using a piezoelectric instrument and a manual scaler. A RME will be cemented with a glass ionomer cement on the maxillary first molars and will be activated by parents on clinicians' instructions. Patients will receive an oral hygiene kit containing toothpaste, soft-bristled toothbrush, single tufted brush and interdental brushes (0.6 and 0.9 mm). Orthodontic wax and 1% chlorhexidine will be given for emergencies. At this point, patients will be divided into two groups:
Read more
- Control group: verbal instructions on the correct activation of the RME and on its cleaning will be given to parents at each visit, together with verbal instructions on the correct daily practices for oral hygiene;
- Trial group: use of "Ortodontika" smartphone application as adjunct to verbal instructions on the correct activation of the RME to be performed by one parent, through a daily notification until T1 (end of activations); parents have to supervise daily oral hygiene of RME and the correct daily practices for oral hygiene. A notification will be sent every 2 weeks until the end of the study to remind patients to watch the videos on oral hygiene maneuverers.
Patients will be visited at the end the activations (T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6). At the recall, the periodontal indices will be evaluated again. At each recall, extra products will be given for home oral hygiene Patients and parents from the Control group will receive a questionnaire to evaluate awareness of orthodontic therapy (aims and phases) and knowledge of oral hygiene maneuverers. Patients and parents from the Trial group will receive an extra questionnaire about Ortodontika application. During the study, the number of emergencies will be recorded.
Read the detailed description
The aim of this study is to evaluate the clinical use of the smartphone application "Ortodontika" for the compliance of orthodontic patients with Rapid Maxillary Expander (RME).
Patients and parents consenting to participate in the study will sign the informed consent for their child. At the baseline (T0), a periodontal examination will be carried out by means of a probe (UNC probe 15; Hu-Friedy, Chicago, IL, USA) assessing Bleeding Index, Plaque Index and Modified Gingival Index on upper first incisors, first premolars/first primary molars and first molars. A professional oral hygiene will be performed using a piezoelectric instrument (Multipiezo, Mectron S.p.a, Carasco, Italy) and a manual scaler (LM23, LM-Dental, Pargas, Finland). A RME will be cemented with a glass ionomer cement (3M Multi-Cure, 3M Unitek, Monrovia, CA, USA) on the maxillary first molars and will be activated by parents on clinicians' instructions. Patients will receive an oral hygiene kit containing toothpaste (GUM Junior 7+, Sunstar Deutschland GmbH, Schonau, Germany), soft-bristled toothbrush (GUM Technique PRO toothbrush), interdental brush 0.6 and 0.8 mm of diameter (GUM TRAV-LER) and a single tufted brush (GUM End-Tuft). Orthodontic wax will be given for emergencies related to RME (GUM ORTHO wax) and 1% chlorhexidine gel (Curasept Periodontal gel, Curasept S.p.A, Saronno, VA, Italy) will be given for gingival inflammation. At this point, patients will be divided into two groups:
- Control group: verbal instructions on the correct activation of the RME and on its cleaning will be given to parents at each visit, together with verbal instructions on the correct daily practices for oral hygiene;
- Trial group: use of "Ortodontika" smartphone application as adjunct to verbal instructions on the correct activation of the RME to be performed by one parent, through a daily notification until T1 (end of activations); parents will have to supervise daily oral hygiene of RME and the correct daily practices for oral hygiene. A notification will be sent every 2 weeks until the end of the study to remind patients to watch the videos on oral hygiene maneuverers.
Patients will be visited at the end of the activations (T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6). At the recall, the periodontal indices will be evaluated and a questionnaire will be given to patients. At each recall, extra products will be given for home oral hygiene. During the study, the number of emergencies will be recorded: RME decementation, patients perceiving pain related to plaque accumulation, mucosal ulcerations due to vestibular tubes, parents that do not understand how to perform RME activations, patients asking the clinician to perform RME activations chairside. A questionnaire will be given to patients and parents belonging to both groups to evaluate awareness of orthodontic therapy aims and phases, knowledge of oral hygiene maneuverers. A questionnaire about Ortodontika application usefulness will be given only to patients and parents belonging to Trial group.
- Conditions
- Maxillary Transverse Deficiency
- Being tested
- Ortodontika app, Verbal instructions
- Keywords
- Oral hygiene, Rapid Maxillary Expander, Smartphone application, Orthopedic treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ortodontika appDevice
parents will download and use Ortodontika smartphone application for all the duration of the study. It will be an aid during orthopedic treatment. During the activations, a notification will be set to remind the daily activation of RME. After the end of the activation protocol, parents will receive a notification every 2 weeks to instruct their children to proper oral hygiene maneuvers. Parents will have to show their children the videos for oral hygiene maintenance every 2 weeks until the end of the study.
Verbal instructionsOther
verbal instructions will be given chairside to patients and parents regarding RME activation and its cleaning, together with instructions for daily oral hygiene manoeuvres.
| Study group | Role | What they receive |
|---|---|---|
| Trial group | Experimental | Patients from this group will be assisted by Orthodontika application during orthopedic treatment. Reminders will be sent for the activation of Rapid Maxillary Expander and for oral hygiene maneuvers. Written information about orthopedic treatment and oral hygiene tips can be read. Receives: Device: Ortodontika app |
| Control group | Other | Patients from this group will not have access to Orthodontika application during orthopedic treatment. Patients will receive only verbal instruction about the activation of Rapid Maxillary Expander and for oral hygiene maneuvers. Receives: Other: Verbal instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Gingival Index (Eppright et al., 2014)
Scoring criteria (one measurement for each tooth: upper first incisors, first premolars/first primary molars and first molars):
- Absence of inflammation
- Mild inflammation (marginal or papillary unit)
- Mild inflammation (entire marginal and papillary unit)
- Moderate inflammation
- Severe inflammation
Measured: Baseline (T0), 1 month (end of activations - T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6)
Change in Bleeding Index (Saxton and van der Ouderaa, 1989)
Scoring criteria (mesio-buccal, direct buccal, and disto-buccal probed gingival sulci of upper first incisors, first premolars/first primary molars and first molars):
- Absence of bleeding after 30 seconds
- Bleeding observed after 30 seconds
- Immediate bleeding
Measured: Baseline (T0), 1 month (end of activations - T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6)
Change in Plaque Index (Quigley et al. 1962)
Scoring criteria (one measurement for the buccal surface of upper first incisors, first premolars/first primary molars and first molars):
- No plaque
- Discontinuous band of plaque at gingival margin
- Up to 1-mm continuous band of plaque at gingival margin
- Band of plaque wider than 1 mm but less than 1/3 of surface
- Plaque covering between 1/3 and 2/3 of surface
- Plaque covering 2/3 or more of surface
Measured: Baseline (T0), 1 month (end of activations - T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6)
Change in Number of emergencies
RME decementation, patients perceiving pain related to plaque accumulation, mucosal ulcerations due to vestibular tubes, parents that do not understand how to perform RME activations, patients asking the clinician to perform RME activations chairside will be collected.
Measured: Baseline (T0), 1 month (end of activations - T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6)
Change in Awareness questionnaire
Parents and patients from both the groups will complete a questionnaire about their awareness on RME treatment and oral hygiene maneuverers with scores from 0 (worst experience) to 10 (best experience).
Measured: Baseline (T0), 1 month (end of activations - T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6)
Change in App questionnaire
Parents and patients from Trial group will complete a questionnaire about Ortodontika application usefulness with scores from 0 (worst experience) to 10 (best experience).
Measured: Baseline (T0), 1 month (end of activations - T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Oct 2022
- Primary completion20 Jan 2025
- Study completion29 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Transverse DeficiencyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel arms.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 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, MS, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539469
- Sponsor's protocol ID
- 2022-ORTODONTIKA
- Status last verified
- Aug 2025
- First submitted
- 7 Sep 2022
- Last updated
- 24 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-months Evaluation of Patients' Compliance and Oral Hygiene During Rapid Maxillary Expander (RME) Treatment Using "Ortodontika" Smartphone Application: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05539469
- Acronym / sponsor ID
- 2022-ORTODONTIKA
- Conditions
- Maxillary Transverse Deficiency
- Keywords
- Oral hygiene, Rapid Maxillary Expander, Smartphone application, Orthopedic treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 29 Jan 2025 (actual)
- First posted
- 14 Sep 2022 (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 this study is to evaluate the clinical use of the smartphone application "Ortodontika" for the compliance of orthodontic patients with Rapid Maxillary Expander (RME).
Patients and parents consenting to participate in the study will sign the informed consent for their child. At the baseline (T0), a periodontal examination will be carried out by means of a probe assessing Bleeding Index, Plaque Index and Modified Gingival Index on upper first incisors, first premolars/first primary molars and first molars. A professional oral hygiene will be performed using a piezoelectric instrument and a manual scaler. A RME will be cemented with a glass ionomer cement on the maxillary first molars and will be activated by parents on clinicians' instructions. Patients will receive an oral hygiene kit containing toothpaste, soft-bristled toothbrush, single tufted brush and interdental brushes (0.6 and 0.9 mm). Orthodontic wax and 1% chlorhexidine will be given for emergencies. At this point, patients will be divided into two groups:
- Control group: verbal instructions on the correct activation of the RME and on its cleaning will be given to parents at each visit, together with verbal instructions on the correct daily practices for oral hygiene;
- Trial group: use of "Ortodontika" smartphone application as adjunct to verbal instructions on the correct activation of the RME to be performed by one parent, through a daily notification until T1 (end of activations); parents have to supervise daily oral hygiene of RME and the correct daily practices for oral hygiene. A notification will be sent every 2 weeks until the end of the study to remind patients to watch the videos on oral hygiene maneuverers.
Patients will be visited at the end the activations (T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6). At the recall, the periodontal indices will be evaluated again. At each recall, extra products will be given for home oral hygiene Patients and parents from the Control group will receive a questionnaire to evaluate awareness of orthodontic therapy (aims and phases) and knowledge of oral hygiene maneuverers. Patients and parents from the Trial group will receive an extra questionnaire about Ortodontika application. During the study, the number of emergencies will be recorded.
Detailed description
The aim of this study is to evaluate the clinical use of the smartphone application "Ortodontika" for the compliance of orthodontic patients with Rapid Maxillary Expander (RME).
Patients and parents consenting to participate in the study will sign the informed consent for their child. At the baseline (T0), a periodontal examination will be carried out by means of a probe (UNC probe 15; Hu-Friedy, Chicago, IL, USA) assessing Bleeding Index, Plaque Index and Modified Gingival Index on upper first incisors, first premolars/first primary molars and first molars. A professional oral hygiene will be performed using a piezoelectric instrument (Multipiezo, Mectron S.p.a, Carasco, Italy) and a manual scaler (LM23, LM-Dental, Pargas, Finland). A RME will be cemented with a glass ionomer cement (3M Multi-Cure, 3M Unitek, Monrovia, CA, USA) on the maxillary first molars and will be activated by parents on clinicians' instructions. Patients will receive an oral hygiene kit containing toothpaste (GUM Junior 7+, Sunstar Deutschland GmbH, Schonau, Germany), soft-bristled toothbrush (GUM Technique PRO toothbrush), interdental brush 0.6 and 0.8 mm of diameter (GUM TRAV-LER) and a single tufted brush (GUM End-Tuft). Orthodontic wax will be given for emergencies related to RME (GUM ORTHO wax) and 1% chlorhexidine gel (Curasept Periodontal gel, Curasept S.p.A, Saronno, VA, Italy) will be given for gingival inflammation. At this point, patients will be divided into two groups:
- Control group: verbal instructions on the correct activation of the RME and on its cleaning will be given to parents at each visit, together with verbal instructions on the correct daily practices for oral hygiene;
- Trial group: use of "Ortodontika" smartphone application as adjunct to verbal instructions on the correct activation of the RME to be performed by one parent, through a daily notification until T1 (end of activations); parents will have to supervise daily oral hygiene of RME and the correct daily practices for oral hygiene. A notification will be sent every 2 weeks until the end of the study to remind patients to watch the videos on oral hygiene maneuverers.
Patients will be visited at the end of the activations (T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6). At the recall, the periodontal indices will be evaluated and a questionnaire will be given to patients. At each recall, extra products will be given for home oral hygiene. During the study, the number of emergencies will be recorded: RME decementation, patients perceiving pain related to plaque accumulation, mucosal ulcerations due to vestibular tubes, parents that do not understand how to perform RME activations, patients asking the clinician to perform RME activations chairside. A questionnaire will be given to patients and parents belonging to both groups to evaluate awareness of orthodontic therapy aims and phases, knowledge of oral hygiene maneuverers. A questionnaire about Ortodontika application usefulness will be given only to patients and parents belonging to Trial group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel arms.
| Arm | Type | Receives |
|---|---|---|
| Trial group | Experimental | Device: Ortodontika appPatients from this group will be assisted by Orthodontika application during orthopedic treatment. Reminders will be sent for the activation of Rapid Maxillary Expander and for oral hygiene maneuvers. Written information about orthopedic treatment and oral hygiene tips can be read. |
| Control group | Other | Other: Verbal instructionsPatients from this group will not have access to Orthodontika application during orthopedic treatment. Patients will receive only verbal instruction about the activation of Rapid Maxillary Expander and for oral hygiene maneuvers. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- patients and their parents are able or willing to give informed consent;
- patients who will begin orthopedic treatment with RME cemented on first maxillary molars and with welded vestibular tubes;
- patients undergone no previous orthopedic/orthodontic treatment;
- parents' willing to download and use Ortodontika application;
- parents possessing an Apple or Android smartphone with iOS ≥ 10.0 or Android ≥ 4.4 versions;
Key exclusion criteria (6 listed)
- no sectional wire appliances in the upper arches;
- no need of additional orthopedic/orthodontic appliances, also in the lower arch;
- no vestibular welded protraction hooks on RME;
- patients taking regular medications for systemic diseases that could alter periodontal conditions and pain perception (antibiotics, antibacterial mouth rinses, NSAIDS, steroids);
- siblings with previous orthopedic treatment with RME;
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 |
|---|---|---|
| Ortodontika appparents will download and use Ortodontika smartphone application for all the duration of the study. It will be an aid during orthopedic treatment. During the activations, a notification will be set to remind the daily activation of RME. After the end of the activation protocol, parents will receive a notification every 2 weeks to instruct their children to proper oral hygiene maneuvers. Parents will have to show their children the videos for oral hygiene maintenance every 2 weeks until the end of the study. | Device | Trial group |
| Verbal instructionsverbal instructions will be given chairside to patients and parents regarding RME activation and its cleaning, together with instructions for daily oral hygiene manoeuvres. | Other | Control group |
Primary outcome
Change in Modified Gingival Index (Eppright et al., 2014)
Time frame: Baseline (T0), 1 month (end of activations - T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6)
Scoring criteria (one measurement for each tooth: upper first incisors, first premolars/first primary molars and first molars): 0. Absence of inflammation 1. Mild inflammation (marginal or papillary unit) 2. Mild inflammation (entire marginal and papillary unit) 3. Moderate inflammation 4. Severe inflammation
Change in Bleeding Index (Saxton and van der Ouderaa, 1989)
Time frame: Baseline (T0), 1 month (end of activations - T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6)
Scoring criteria (mesio-buccal, direct buccal, and disto-buccal probed gingival sulci of upper first incisors, first premolars/first primary molars and first molars): 0. Absence of bleeding after 30 seconds 1. Bleeding observed after 30 seconds 2. Immediate bleeding
Change in Plaque Index (Quigley et al. 1962)
Time frame: Baseline (T0), 1 month (end of activations - T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6)
Scoring criteria (one measurement for the buccal surface of upper first incisors, first premolars/first primary molars and first molars): 0. No plaque 1. Discontinuous band of plaque at gingival margin 2. Up to 1-mm continuous band of plaque at gingival margin 3. Band of plaque wider than 1 mm but less than 1/3 of surface 4. Plaque covering between 1/3 and 2/3 of surface 5. Plaque covering 2/3 or more of surface
Change in Number of emergencies
Time frame: Baseline (T0), 1 month (end of activations - T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6)
RME decementation, patients perceiving pain related to plaque accumulation, mucosal ulcerations due to vestibular tubes, parents that do not understand how to perform RME activations, patients asking the clinician to perform RME activations chairside will be collected.
Change in Awareness questionnaire
Time frame: Baseline (T0), 1 month (end of activations - T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6)
Parents and patients from both the groups will complete a questionnaire about their awareness on RME treatment and oral hygiene maneuverers with scores from 0 (worst experience) to 10 (best experience).
Change in App questionnaire
Time frame: Baseline (T0), 1 month (end of activations - T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6)
Parents and patients from Trial group will complete a questionnaire about Ortodontika application usefulness with scores from 0 (worst experience) to 10 (best experience).
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 24 Aug 2025.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the corresponding author.
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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, MS 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 Ortodontika app and Verbal instructions in people with Maxillary Transverse Deficiency, 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 6 inclusion and 6 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 24 Aug 2025. 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 Modified Gingival Index (Eppright et al., 2014) (time frame: Baseline (T0), 1 month (end of activations - T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6)). The study lists 6 primary outcomes in all. 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 24 Aug 2025.