MalocclusionNCT04105127
Pain and Discomfort With Anterior Versus Posterior Builds-up
A study testing orthodontic - Anterior resin builds-ups and orthodontic - Posterior resin builds-ups in people with Malocclusion and Deep Bite, run by University of Genova at 1 site in Italy.
Trial summary
Orthodontic build-ups are made by composite/resin material bonded to the palatal or occlusal surfaces of teeth (usually molars or incisors). Their primary purpose is to prevent heavy contact of the upper teeth with lower fixed appliances in patients with overbite reduction to avoid brackets detachment. Read more about this study
- Who is it for?
- Ages 9 to 50 years
- Conditions the study is for
- Malocclusion, Deep Bite
- What is being tested?
- orthodontic - Anterior resin builds-ups and orthodontic - Posterior resin builds-ups
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2020to 30 Sep 2020
- 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 9 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient with reduced overbite treated with orthodontic fixed appliance
- Angle Class I, Class II or Class III malocclusion
Who cannot join
- Hypodontia in any quadrant excluding third molars
- Craniofacial syndromes, or cleft lip or palate
Trial locations and contacts
1 site in 1 country.
Italy1 site
Alessandro Ugolini
Genova, GE, 16129
Alessandro Ugolini, 3475971340, alessandro.ugolini@unige.it
About this study
Official title: Pain and Discomfort With Anterior Versus Posterior Builds-up During Fixed Orthodontic Treatment: a Randomized Clinical Trial
Orthodontic build-ups are made by composite/resin material bonded to the palatal or occlusal surfaces of teeth (usually molars or incisors). Their primary purpose is to prevent heavy contact of the upper teeth with lower fixed appliances in patients with overbite reduction to avoid brackets detachment. These appliances disarticulate the posterior teeth, deprogram the masticatory muscles and allow for eruption, extrusion, and uprighting of the posterior teeth. Build-ups are usually placed in the first months of the fixed orthodontic treatment and contribute to increasing the perception of pain. In the orthodontic daily practice, the pain is the most frequent symptom during treatment and is the one that most frightens/worries the patients. Literature shows that fear of pain is one of the primary reasons that patients fail to seek orthodontic care. Pain has a negative effect on patients' compliance, oral hygiene, and missed appointments. Its effects on patients' daily lives is a major reason for discontinuance of orthodontic treatment.
In the literature the prevention of pain and management of orthodontic builds-ups is a poorly analyzed topic, despite being a daily problem in orthodontic clinical practice. So, the aim of the present study is to investigate and analyze the perception of pain and function impairment with different type of build-ups (anterior or posterior) to identify an efficient clinical management protocol and an effective pain and discomfort prevention strategy.
- Conditions
- Malocclusion, Deep Bite
- Being tested
- orthodontic - Anterior resin builds-ups, orthodontic - Posterior resin builds-ups
- Medical subject headings
- Malocclusion, Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthodontic - Anterior resin builds-upsDevice
Also called Anterior resin bite turbos
After lower brackets placement, resin builds-ups are added on the palatal aspect of the upper central incisors. Both central incisors are customarily bonded to broadly distribute the occlusal forces. Builds-ups are removed when the overbite was considered adequate to prevent lower brackets detachment.
orthodontic - Posterior resin builds-upsDevice
Also called Posterior resin bite turbos
After lower brackets placement, resin builds-ups are added on the supporting cusps of first or second upper/lower molars. Builds-ups are removed when the overbite was considered adequate to prevent lower brackets detachment.
| Study group | Role | What they receive |
|---|---|---|
| Anterior builds-ups | Active comparator | Intervention orthodontic - fixed orthodontic treatment in patients with overbite reduction: fixed orthodontic treatment with resin build-ups bonded to the palatal surfaces of central upper incisors Receives: Device: orthodontic - Anterior resin builds-ups |
| Posterior builds-ups | Active comparator | Intervention orthodontic - fixed orthodontic treatment in patients with overbite reduction: fixed orthodontic treatment with resin build-ups bonded to the occlusal surfaces of first or second upper/lower molars Receives: Device: orthodontic - Posterior resin builds-ups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overbite correction [Millimeters]
Overbite Clinical evaluation in vivo (continuous outcome, millimeters)
Measured: 1 week
Overbite correction [Millimeters]
Overbite Clinical evaluation in vivo (continuous outcome, millimeters)
Measured: 1 months
Overbite correction [Millimeters]
Overbite Clinical evaluation in vivo (continuous outcome, millimeters)
Measured: 2 months
Overbite correction [Millimeters]
Overbite Clinical evaluation in vivo (continuous outcome, millimeters)
Measured: 3 months
Overbite correction [Time]
Overbite Clinical evaluation in vivo (continuous outcome, months)
Measured: 1 months
Overbite correction [Time]
Overbite Clinical evaluation in vivo (continuous outcome, months)
Measured: 2 months
Overbite correction [Time]
Overbite Clinical evaluation in vivo (continuous outcome, months)
Measured: 3 months
Pain after builds-up placement
Visual Analogic Scale (VAS) were used to evaluate the level of pain. The Visual Analog Scale (VAS) is most commonly a straight 100-mm line, without demarcation, that has the words "no pain" at the left-most end and "worst pain imaginable" (or something similar) at the right-most end. Patients are instructed to place a mark on the line indicating the amount of pain that they feel at the time of the evaluation. The distance of this mark from the left end is then measured, and this number is used as a numeric representation of the severity of the patient's pain.
Measured: 1 week
Pain after builds-up placement
Visual Analogic Scale (VAS) were used to evaluate the level of pain. The Visual Analog Scale (VAS) is most commonly a straight 100-mm line, without demarcation, that has the words "no pain" at the left-most end and "worst pain imaginable" (or something similar) at the right-most end. Patients are instructed to place a mark on the line indicating the amount of pain that they feel at the time of the evaluation. The distance of this mark from the left end is then measured, and this number is used as a numeric representation of the severity of the patient's pain.
Measured: 1 months
Pain after builds-up placement
Visual Analogic Scale (VAS) were used to evaluate the level of pain. The Visual Analog Scale (VAS) is most commonly a straight 100-mm line, without demarcation, that has the words "no pain" at the left-most end and "worst pain imaginable" (or something similar) at the right-most end. Patients are instructed to place a mark on the line indicating the amount of pain that they feel at the time of the evaluation. The distance of this mark from the left end is then measured, and this number is used as a numeric representation of the severity of the patient's pain.
Measured: 2 months
Pain after builds-up placement
Visual Analogic Scale (VAS) were used to evaluate the level of pain. The Visual Analog Scale (VAS) is most commonly a straight 100-mm line, without demarcation, that has the words "no pain" at the left-most end and "worst pain imaginable" (or something similar) at the right-most end. Patients are instructed to place a mark on the line indicating the amount of pain that they feel at the time of the evaluation. The distance of this mark from the left end is then measured, and this number is used as a numeric representation of the severity of the patient's pain.
Measured: 3 months
Oral Health Impact Profile after builds-up placement
Instrument of data collection was OHIP-14 questionnaire, which comprises of 14 questions with two questions each under seven domains. The domains include; functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. Responses to the questions are based on a Likert scale which ranged from 0- "never" to 4- "very often". Variables also included in the questionnaire were: demographic variables and satisfaction ratings of teeth appearance and self- rating of tooth condition. The satisfaction ratings of tooth appearance assessed how satisfied the participants were with the appearance of their teeth with a response of "satisfied or dissatisfied". The self- rating of tooth condition assessed oral condition as being "good or poor". The satisfaction ratings and self-ratings of oral health were variables used to assess the construct validity of OHIP-14 in the respondents
Measured: 1 week
Oral Health Impact Profile after builds-up placement
Instrument of data collection was OHIP-14 questionnaire, which comprises of 14 questions with two questions each under seven domains. The domains include; functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. Responses to the questions are based on a Likert scale which ranged from 0- "never" to 4- "very often". Variables also included in the questionnaire were: demographic variables and satisfaction ratings of teeth appearance and self- rating of tooth condition. The satisfaction ratings of tooth appearance assessed how satisfied the participants were with the appearance of their teeth with a response of "satisfied or dissatisfied". The self- rating of tooth condition assessed oral condition as being "good or poor". The satisfaction ratings and self-ratings of oral health were variables used to assess the construct validity of OHIP-14 in the respondents
Measured: 1 months
Oral Health Impact Profile after builds-up placement
Instrument of data collection was OHIP-14 questionnaire, which comprises of 14 questions with two questions each under seven domains. The domains include; functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. Responses to the questions are based on a Likert scale which ranged from 0- "never" to 4- "very often". Variables also included in the questionnaire were: demographic variables and satisfaction ratings of teeth appearance and self- rating of tooth condition. The satisfaction ratings of tooth appearance assessed how satisfied the participants were with the appearance of their teeth with a response of "satisfied or dissatisfied". The self- rating of tooth condition assessed oral condition as being "good or poor". The satisfaction ratings and self-ratings of oral health were variables used to assess the construct validity of OHIP-14 in the respondents
Measured: 2 months
Oral Health Impact Profile after builds-up placement
Instrument of data collection was OHIP-14 questionnaire, which comprises of 14 questions with two questions each under seven domains. The domains include; functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. Responses to the questions are based on a Likert scale which ranged from 0- "never" to 4- "very often". Variables also included in the questionnaire were: demographic variables and satisfaction ratings of teeth appearance and self- rating of tooth condition. The satisfaction ratings of tooth appearance assessed how satisfied the participants were with the appearance of their teeth with a response of "satisfied or dissatisfied". The self- rating of tooth condition assessed oral condition as being "good or poor". The satisfaction ratings and self-ratings of oral health were variables used to assess the construct validity of OHIP-14 in the respondents
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Jan 2020 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALESSANDRO UGOLINI, University of Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105127
- Sponsor's protocol ID
- RCT Builds-ups
- Status last verified
- Sep 2019
- First submitted
- 6 Jun 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Corridore D, Campus G, Guerra F, Ripari F, Sale S, Ottolenghi L. Validation of the Italian version of the Oral Health Impact Profile-14 (IOHIP-14). Ann Stomatol (Roma). 2014 Feb 4;4(3-4):239-43. eCollection 2013 Jul-Dec.
PubMed 24611088Kravitz ND, Jorgensen G, Frey S, Cope J. Resin bite turbos. J Clin Orthod. 2018 Sep;52(9):456-461. No abstract available.
PubMed 30256220Antoun JS, Thomson WM, Merriman TR, Rongo R, Farella M. Impact of skeletal divergence on oral health-related quality of life and self-reported jaw function. Korean J Orthod. 2017 May;47(3):186-194. doi: 10.4041/kjod.2017.47.3.186. Epub 2017 Mar 13.
PubMed 28523245Pativetpinyo D, Supronsinchai W, Changsiripun C. Immediate effects of temporary bite-raising with light-cured orthodontic band cement on the electromyographic response of masticatory muscles. J Appl Oral Sci. 2018 May 14;26:e20170214. doi: 10.1590/1678-7757-2017-0214.
PubMed 29768521
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Discomfort With Anterior Versus Posterior Builds-up During Fixed Orthodontic Treatment: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04105127
- Acronym / sponsor ID
- RCT Builds-ups
- Conditions
- Malocclusion, Deep Bite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 26 Sep 2019 (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.
Orthodontic build-ups are made by composite/resin material bonded to the palatal or occlusal surfaces of teeth (usually molars or incisors). Their primary purpose is to prevent heavy contact of the upper teeth with lower fixed appliances in patients with overbite reduction to avoid brackets detachment. These appliances disarticulate the posterior teeth, deprogram the masticatory muscles and allow for eruption, extrusion, and uprighting of the posterior teeth. Build-ups are usually placed in the first months of the fixed orthodontic treatment and contribute to increasing the perception of pain. In the orthodontic daily practice, the pain is the most frequent symptom during treatment and is the one that most frightens/worries the patients. Literature shows that fear of pain is one of the primary reasons that patients fail to seek orthodontic care. Pain has a negative effect on patients' compliance, oral hygiene, and missed appointments. Its effects on patients' daily lives is a major reason for discontinuance of orthodontic treatment.
In the literature the prevention of pain and management of orthodontic builds-ups is a poorly analyzed topic, despite being a daily problem in orthodontic clinical practice. So, the aim of the present study is to investigate and analyze the perception of pain and function impairment with different type of build-ups (anterior or posterior) to identify an efficient clinical management protocol and an effective pain and discomfort prevention strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior builds-ups | Active comparator | Device: orthodontic - Anterior resin builds-upsIntervention orthodontic - fixed orthodontic treatment in patients with overbite reduction: fixed orthodontic treatment with resin build-ups bonded to the palatal surfaces of central upper incisors |
| Posterior builds-ups | Active comparator | Device: orthodontic - Posterior resin builds-upsIntervention orthodontic - fixed orthodontic treatment in patients with overbite reduction: fixed orthodontic treatment with resin build-ups bonded to the occlusal surfaces of first or second upper/lower molars |
Who may qualify
- Ages
- 9 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patient with reduced overbite treated with orthodontic fixed appliance
- Angle Class I, Class II or Class III malocclusion
Key exclusion criteria (2 listed)
- Hypodontia in any quadrant excluding third molars
- Craniofacial syndromes, or cleft lip or palate
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 |
|---|---|---|
| orthodontic - Anterior resin builds-upsAlso: Anterior resin bite turbosAfter lower brackets placement, resin builds-ups are added on the palatal aspect of the upper central incisors. Both central incisors are customarily bonded to broadly distribute the occlusal forces. Builds-ups are removed when the overbite was considered adequate to prevent lower brackets detachment. | Device | Anterior builds-ups |
| orthodontic - Posterior resin builds-upsAlso: Posterior resin bite turbosAfter lower brackets placement, resin builds-ups are added on the supporting cusps of first or second upper/lower molars. Builds-ups are removed when the overbite was considered adequate to prevent lower brackets detachment. | Device | Posterior builds-ups |
Primary outcome
Overbite correction [Millimeters]
Time frame: 1 week
Overbite Clinical evaluation in vivo (continuous outcome, millimeters)
Overbite correction [Millimeters]
Time frame: 1 months
Overbite Clinical evaluation in vivo (continuous outcome, millimeters)
Overbite correction [Millimeters]
Time frame: 2 months
Overbite Clinical evaluation in vivo (continuous outcome, millimeters)
Overbite correction [Millimeters]
Time frame: 3 months
Overbite Clinical evaluation in vivo (continuous outcome, millimeters)
Overbite correction [Time]
Time frame: 1 months
Overbite Clinical evaluation in vivo (continuous outcome, months)
Overbite correction [Time]
Time frame: 2 months
Overbite Clinical evaluation in vivo (continuous outcome, months)
Overbite correction [Time]
Time frame: 3 months
Overbite Clinical evaluation in vivo (continuous outcome, months)
Pain after builds-up placement
Time frame: 1 week
Visual Analogic Scale (VAS) were used to evaluate the level of pain. The Visual Analog Scale (VAS) is most commonly a straight 100-mm line, without demarcation, that has the words "no pain" at the left-most end and "worst pain imaginable" (or something similar) at the right-most end. Patients are instructed to place a mark on the line indicating the amount of pain that they feel at the time of the evaluation. The distance of this mark from the left end is then measured, and this number is used as a numeric representation of the severity of the patient's pain.
Pain after builds-up placement
Time frame: 1 months
Visual Analogic Scale (VAS) were used to evaluate the level of pain. The Visual Analog Scale (VAS) is most commonly a straight 100-mm line, without demarcation, that has the words "no pain" at the left-most end and "worst pain imaginable" (or something similar) at the right-most end. Patients are instructed to place a mark on the line indicating the amount of pain that they feel at the time of the evaluation. The distance of this mark from the left end is then measured, and this number is used as a numeric representation of the severity of the patient's pain.
Pain after builds-up placement
Time frame: 2 months
Visual Analogic Scale (VAS) were used to evaluate the level of pain. The Visual Analog Scale (VAS) is most commonly a straight 100-mm line, without demarcation, that has the words "no pain" at the left-most end and "worst pain imaginable" (or something similar) at the right-most end. Patients are instructed to place a mark on the line indicating the amount of pain that they feel at the time of the evaluation. The distance of this mark from the left end is then measured, and this number is used as a numeric representation of the severity of the patient's pain.
Pain after builds-up placement
Time frame: 3 months
Visual Analogic Scale (VAS) were used to evaluate the level of pain. The Visual Analog Scale (VAS) is most commonly a straight 100-mm line, without demarcation, that has the words "no pain" at the left-most end and "worst pain imaginable" (or something similar) at the right-most end. Patients are instructed to place a mark on the line indicating the amount of pain that they feel at the time of the evaluation. The distance of this mark from the left end is then measured, and this number is used as a numeric representation of the severity of the patient's pain.
Oral Health Impact Profile after builds-up placement
Time frame: 1 week
Instrument of data collection was OHIP-14 questionnaire, which comprises of 14 questions with two questions each under seven domains. The domains include; functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. Responses to the questions are based on a Likert scale which ranged from 0- "never" to 4- "very often". Variables also included in the questionnaire were: demographic variables and satisfaction ratings of teeth appearance and self- rating of tooth condition. The satisfaction ratings of tooth appearance assessed how satisfied the participants were with the appearance of their teeth with a response of "satisfied or dissatisfied". The self- rating of tooth condition assessed oral condition as being "good or poor". The satisfaction ratings and self-ratings of oral health were variables used to assess the construct validity of OHIP-14 in the respondents
Oral Health Impact Profile after builds-up placement
Time frame: 1 months
Instrument of data collection was OHIP-14 questionnaire, which comprises of 14 questions with two questions each under seven domains. The domains include; functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. Responses to the questions are based on a Likert scale which ranged from 0- "never" to 4- "very often". Variables also included in the questionnaire were: demographic variables and satisfaction ratings of teeth appearance and self- rating of tooth condition. The satisfaction ratings of tooth appearance assessed how satisfied the participants were with the appearance of their teeth with a response of "satisfied or dissatisfied". The self- rating of tooth condition assessed oral condition as being "good or poor". The satisfaction ratings and self-ratings of oral health were variables used to assess the construct validity of OHIP-14 in the respondents
Oral Health Impact Profile after builds-up placement
Time frame: 2 months
Instrument of data collection was OHIP-14 questionnaire, which comprises of 14 questions with two questions each under seven domains. The domains include; functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. Responses to the questions are based on a Likert scale which ranged from 0- "never" to 4- "very often". Variables also included in the questionnaire were: demographic variables and satisfaction ratings of teeth appearance and self- rating of tooth condition. The satisfaction ratings of tooth appearance assessed how satisfied the participants were with the appearance of their teeth with a response of "satisfied or dissatisfied". The self- rating of tooth condition assessed oral condition as being "good or poor". The satisfaction ratings and self-ratings of oral health were variables used to assess the construct validity of OHIP-14 in the respondents
Oral Health Impact Profile after builds-up placement
Time frame: 3 months
Instrument of data collection was OHIP-14 questionnaire, which comprises of 14 questions with two questions each under seven domains. The domains include; functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. Responses to the questions are based on a Likert scale which ranged from 0- "never" to 4- "very often". Variables also included in the questionnaire were: demographic variables and satisfaction ratings of teeth appearance and self- rating of tooth condition. The satisfaction ratings of tooth appearance assessed how satisfied the participants were with the appearance of their teeth with a response of "satisfied or dissatisfied". The self- rating of tooth condition assessed oral condition as being "good or poor". The satisfaction ratings and self-ratings of oral health were variables used to assess the construct validity of OHIP-14 in the respondents
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Results publication: PubMed 24611088Corridore D, Campus G, Guerra F, Ripari F, Sale S, Ottolenghi L. Validation of the Italian version of the Oral Health Impact Profile-14 (IOHIP-14). Ann Stomatol (Roma). 2014 Feb 4;4(3-4):239-43. eCollection 2013 Jul-Dec.
- Results publication: PubMed 30256220Kravitz ND, Jorgensen G, Frey S, Cope J. Resin bite turbos. J Clin Orthod. 2018 Sep;52(9):456-461. No abstract available.
- Results publication: PubMed 28523245Antoun JS, Thomson WM, Merriman TR, Rongo R, Farella M. Impact of skeletal divergence on oral health-related quality of life and self-reported jaw function. Korean J Orthod. 2017 May;47(3):186-194. doi: 10.4041/kjod.2017.47.3.186. Epub 2017 Mar 13.
- Results publication: PubMed 29768521Pativetpinyo D, Supronsinchai W, Changsiripun C. Immediate effects of temporary bite-raising with light-cured orthodontic band cement on the electromyographic response of masticatory muscles. J Appl Oral Sci. 2018 May 14;26:e20170214. doi: 10.1590/1678-7757-2017-0214.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orthodontic - Anterior resin builds-ups and orthodontic - Posterior resin builds-ups in people with Malocclusion and Deep Bite, run by University of Genova 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 2 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: status not confirmed, as of the sponsor's last update on 26 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Ugolini, DDS Phd (3475971340, alessandro.ugolini@unige.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overbite correction [Millimeters] (time frame: 1 week). The study lists 15 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 NCT04105127, which also lists 4 linked publications.
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 26 Sep 2019.