Obstructive Sleep ApneaNCT05420129
Side Effects of the Mandibular Advancement Device for Apnea Treatment on Dental Occlusion and Masticatory Function
An observational study of Obstructive Sleep Apnea, run by University of Barcelona at 1 site in Spain.
Trial summary
This study evaluates the effect of the use of mandibular advancement devices (MAD) on dental occlusion and masticatory function during the first two years of obstructive sleep apnea (OSA) treatment. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- MAD Therapy and CPAP Therapy
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 30 Nov 2023to 31 May 2032
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with sleep apnea and treated with CPAP or MAD
Who may be able to join
- Being diagnosed with OSA by polisomnography (IAH>15).
Who cannot join
- Be treated with MAD or CPAP during more than 3 months in the lasts 5 years.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Odontologic Universitat de Barcelona
L'Hospitalet de Llobregat, 08907
About this study
Official title: Side Effects of the Use of the Mandibular Advancement Device for Treatment of Obstructive Sleep Apnea on Dental Occlusion and Masticatory Function
This study evaluates the effect of the use of mandibular advancement devices (MAD) on dental occlusion and masticatory function during the first two years of obstructive sleep apnea (OSA) treatment.
52 participants diagnosed with obstructive sleep apnea will be studied, 26 will be treated with MAD and 26 participants will be treated with continuous positive airway pressure (CPAP) as a control group.
Participants will perform masticatory tests to assess masticatory performance in comminute and mixing capacity. Masticatory satisfaction perceived by the participants will be evaluated by questionnaires. Occlusal contact area and other occlusal characteristics will be assessed using occlusal silicone and T-Scan registrations and 3D digital models obtained with intraoral scan. Data collection will be performed before treatment with MAD or CPAP, and at 3, 6, 12, and 24 months from the start of treatment.
Read the detailed description
This prospective observational non-randomized clinical study aims to assess the effect of use MAD on masticatory performance. 52 subjects diagnosed with OSA will participate in this study divided into two different groups: 26 treated with MAD and 26 treated with CPAP. Data collection will be carried out before the start of treatment of the two modalities and at 3, 6, 12 and 24 months after starting the treatment. The intervention of the study will be based on execute chewing tests to evaluate masticatory performance from artificial food. Other aspects of matsticatory function would be also explored like subjective masticatory performance and jaw function limitation, dental position and occlusion, bite force or dental mobility. Artificial food tests will evaluate masticatory performance in comminute and mixing ability to determine the degree of reduction in masticatory performance produced by the use of MAD after 3 months of treatment. The main variable to be studied will be the median particle size of silicone tablets from Optozeta's test. This test is based on chewing 2 grams of silicone tablets inside a latex bag in order to evaluate their degree of comminution. The greater of grinded silicone, the greater of chewing performance. Another masticatory performance test will also be carried out is evaluation subject's mixing capacity with a two-colour chewing gum test. Degree of mixing of two colours of the gum will be checked after 40 chewing cycles. The more uniformity of the colour obtained, the more mixing ability the subject will demonstrate. A CPAP group control will be used, which will additionally allows us to know if this treatment has effects on dental position, occlusion and masticatory performance.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- MAD Therapy, CPAP Therapy
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAD TherapyDevice
Participants will be treated with a Mandibular Advancement Device therapy
CPAP TherapyDevice
Participants will be treated with a Continuous Positive Airway Pressure therapy
| Study group | Role | What they receive |
|---|---|---|
| MAD. Mandibular advancement Device | Patients diagnosed with Obstructive Sleep Apnea and treated with MAD Receives: Device: MAD Therapy | |
| CPAP. Continuous Possitive Airway Pressure | Patients diagnosed with Obstructive Sleep Apnea and treated with CPAP Receives: Device: CPAP Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in masticatory perfomance at 6 months
The masticatory performance will be evaluated by assessing the degree of comminution of the silicon test food (Median particle size). The particles from five trials (10 g) will be dried and passed through a series of eight sieves (0.25, 0.425, 0.85, 2, 2.8, 3.15, 4, and 5.6 mm) while being shaken for 6 min. Once the cumulative weight distribution of the sieve contents will be determined, the median particle size (MPS) will be calculated for each subject using the Rosin-Rammler equation [Qw (X) = 1 - 2E-(X/ X50)b], where Qw (X) is the fraction of particles by weight with a diameter smaller than X; X50 (or MPS) is the size of a theoretical sieve through which 50% of the weight would pass; and b describes the breadth of the particle size distribution. Therefore, the lower the MPS, the better the masticatory performance. Participants will perform masticatory tests before and 6 months after treatment.
Measured: Before treatment and 6 months after treatment
Change in masticatory perfomance at 24 months
The masticatory performance will be evaluated by assessing the degree of comminution of the silicon test food (Median particle size). The particles from five trials (10 g) will be dried and passed through a series of eight sieves (0.25, 0.425, 0.85, 2, 2.8, 3.15, 4, and 5.6 mm) while being shaken for 6 min. Once the cumulative weight distribution of the sieve contents will be determined, the median particle size (MPS) will be calculated for each subject using the Rosin-Rammler equation [Qw (X) = 1 - 2E-(X/ X50)b], where Qw (X) is the fraction of particles by weight with a diameter smaller than X; X50 (or MPS) is the size of a theoretical sieve through which 50% of the weight would pass; and b describes the breadth of the particle size distribution. Therefore, the lower the MPS, the better the masticatory performance. Participants will perform masticatory tests before and 24 months after treatment.
Measured: Before treatment and 24 months after treatment
Secondary outcomes (24)
Change in masticatory mixing ability at 6 months
Masticatory mixing ability will be measured using the standard deviation of red channel in RGB image of a colour histogram. It will be assessed by doing a two-colour gum chewing test. Higher values of the standard deviation of red channel will indicate poor masticatory mixing ability. Participants will perform masticatory tests before and 6 months after treatment.
Measured: Before treatment and 6 months after treatment
Change in masticatory mixing ability at 24 months
Masticatory mixing ability will be measured using the standard deviation of red channel in RGB image of a colour histogram. It will be assessed by doing a two-colour gum chewing test. Higher values of the standard deviation of red channel will indicate poor masticatory mixing ability. Participants will perform masticatory tests before and 24 months after treatment.
Measured: Before treatment and 24 months after treatment
Change in the degree of satisfaction in masticatory function at 6 months
The change in the degree of satisfaction in masticatory function at 6 months will be assessed by asking the question "How satisfied are the participants with their masticatory function? using a 0-10 point scale, considering 0 totally dissatisfied and 10 totally satisfied. Participants will rate before treatment and 6 months after treatment.
Measured: Before treatment and 6 months after treatment
Change in the degree of satisfaction in masticatory function at 24 months
The change in the degree of satisfaction in masticatory function at 24 months will be assessed by asking the question "How satisfied are the participants with their masticatory function? using a 0-10 point scale, considering 0 totally dissatisfied and 10 totally satisfied. Participants will rate before treatment and 24 months after treatment.
Measured: Before treatment and 24 months after treatment
Change in chewing ability at 6 months
The change in chewing ability will be assessed by filling out a questionnaire about differents types of food. For each food, the participant will ask the question "How able are the participants to chew this food? using a 0-10 point scale, considering 0 totally unable and 10 totally able. Participants will rate before treatment and 6 months after treatment.
Measured: Before treatment and 6 months after treatment
Change in chewing ability at 24 months
The change in chewing ability will be assessed by filling out a questionnaire about differents types of food. For each food, the participant will ask the question "How able are the participants to chew this food? using a 0-10 point scale, considering 0 totally unable and 10 totally able. Participants will rate before treatment and 24 months after treatment.
Measured: Before treatment and 24 months after treatment
Change in jaw functional limitation.at 6 months
The change in jaw functional limitation will be assessed by filling out the Jaw Functional Limitation Scale (JFLS-20), with the question: "For each of the items, indicate the level of limitation anbout the following functions", using a 0-10 point scale, considering 0 no limitation and 10 severe limitation. Participants will rate before treatment and 6 months after treatment.
Measured: Before treatment and 6 months after treatment
Change in jaw functional limitation.at 24 months
The change in jaw functional limitation will be assessed by filling out the Jaw Functional Limitation Scale (JFLS-20), with the question: "For each of the items, indicate the level of limitation anbout the following functions", using a 0-10 point scale, considering 0 no limitation and 10 severe limitation. Participants will rate before treatment and 24 months after treatment.
Measured: Before treatment and 24 months after treatment
Change in masticatory rhythm at 6 months
Change in masticatory rhythm will be assessed as chewing cycle duration (in msec) measuring the the time taken to perform the 20 masticatory cycles of Optozeta's test and divided by 20. Participants will perform masticatory tests before and 6 months after treatment.
Measured: Before treatment and 6 months after treatment
Change in masticatory rhythm at 24 months
Change in masticatory rhythm will be assessed as chewing cycle duration (in msec) measuring the the time taken to perform the 20 masticatory cycles of Optozeta's test and divided by 20. Participants will perform masticatory tests before and 24 months after treatment.
Measured: Before treatment and 24 months after treatment
Change in masticatory laterality at 6 months
Change in masticatory laterality will be assessed by using the Asymmetry masticatory index, as = (number of right strokes - number of left strokes)/(number of right strokes + number of left strokes). Participants will perform masticatory tests before and 6 months after treatment.
Measured: Before treatment and 6 months after treatment
Change in masticatory laterality at 24 months
Change in masticatory laterality will be assessed by using the Asymmetry masticatory index, as = (number of right strokes - number of left strokes)/(number of right strokes + number of left strokes). Participants will perform masticatory tests before and 24 months after treatment.
Measured: Before treatment and 24 months after treatment
Change in masticatory side-switch frequency at 6 months
Change in masticatory side-switch frequency will be assessed by using the masticatory side-switch index. The number of side switches during the 20 masticatory cycles for each assay will be determined using slow playback of the video recordings of the freestyle mastication test. In the case that this switch is a change of side from left to right or right to left, a value of "1" will be assigned. If this switch consists of a change from the right or left to central or vice versa, a value of "0.5" will be assigned. If there is no change of side, the value assigned to this chewing cycle will be "0". To determine the Side Switch Index, the number of side changes will be divided by the maximum number of changes possible during these 5 assays (95). Participants will perform masticatory tests before and 6 months after treatment.
Measured: Before treatment and 6 months after treatment
Change in masticatory side-switch frequency at 24 months
Change in masticatory side-switch frequency will be assessed by using the masticatory side-switch index. The number of side switches during the 20 masticatory cycles for each assay will be determined using slow playback of the video recordings of the freestyle mastication test. In the case that this switch is a change of side from left to right or right to left, a value of "1" will be assigned. If this switch consists of a change from the right or left to central or vice versa, a value of "0.5" will be assigned. If there is no change of side, the value assigned to this chewing cycle will be "0". To determine the Side Switch Index, the number of side changes will be divided by the maximum number of changes possible during these 5 assays (95). Participants will perform masticatory tests before and 24 months after treatment.
Measured: Before treatment and 24 months after treatment
Change in overjet at 6 months
Change in overjet will be assessed by measuring horizontal dicrepancy on the incisal edge of maxillary and mandibular central incisors, in mm. Participants will be examined before and 6 months after treatment.
Measured: Before treatment and 6 months after treatment
Change in overjet at 24 months
Change in overjet will be assessed by measuring horizontal dicrepancy on the incisal edge of maxillary and mandibular central incisors, in mm. Participants will be examined before and 24 months after treatment.
Measured: Before treatment and 24 months after treatment
Change in overbite at 6 months
Change in overbite will be assessed by measuring the vertical dicrepancy on the incisal edge of maxillary and mandibular central incisors, in mm. Participants will be examined before and 6 months after treatment.
Measured: Before treatment and 6 months after treatment
Change in overbite at 24 months
Change in overbite will be assessed by measuring the vertical dicrepancy on the incisal edge of maxillary and mandibular central incisors, in mm. Participants will be examined before and 24 months after treatment.
Measured: Before treatment and 24 months after treatment
Change in occlusal contact area at 6 months
Change in occlusal contact area will be assessed by using interocclusal records and considering occlusal contact a distance < of 200 µm between upper and lower teeth. Occlusal records at the intercuspal position will be taken before and 6 months after treatment.
Measured: Before treatment and 6 months after treatment
Change in occlusal contact area at 24 months
Change in occlusal contact area will be assessed by using interocclusal records and considering occlusal contact a distance < of 200 µm between upper and lower teeth. Occlusal records at the intercuspal position will be taken before and 24 months after treatment.
Measured: Before treatment and 24 months after treatment
Change in bite force at 6 months
Change in unilateral bite force will the evaluated biting a gnathodynamometer (in Newtons). Bite force will be determined before and 6 months after treatment.
Measured: Before treatment and 6 months after treatment
Change in bite force at 24 months
Change in unilateral bite force will the evaluated biting a gnathodynamometer (in Newtons). Bite force will be determined before and 24 months after treatment.
Measured: Before treatment and 24 months after treatment
Change in dental mobility at 6 months
Change in dental mobility will be assessed by using the a PerioTest device. Values range from -8 (no mobility) to 50 (maximum mobility). Dental mobility will be determined before and 6 months after treatment.
Measured: Before treatment and 6 months after treatment
Change in dental mobility at 24 months
Change in dental mobility will be assessed by using the a PerioTest device. Values range from -8 (no mobility) to 50 (maximum mobility). Dental mobility will be determined before and 24 months after treatment.
Measured: Before treatment and 24 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start30 Nov 2023
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2032 (estimated)
Why it stopped: The researcher who would recruit the participants is not longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordi Martinez-Gomis, University of Barcelona
- Investigators
- Eva Willaert, DDS PhD, Study director, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420129
- Sponsor's protocol ID
- HOUB2021/039
- Status last verified
- Mar 2025
- First submitted
- 24 May 2022
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data could be shared under a reasonable request
Publications
Ayuso-Montero R, Mariano-Hernandez Y, Khoury-Ribas L, Rovira-Lastra B, Willaert E, Martinez-Gomis J. Reliability and Validity of T-scan and 3D Intraoral Scanning for Measuring the Occlusal Contact Area. J Prosthodont. 2020 Jan;29(1):19-25. doi: 10.1111/jopr.13096. Epub 2019 Jul 21.
PubMed 31270888Schimmel M, Christou P, Miyazaki H, Halazonetis D, Herrmann FR, Muller F. A novel colourimetric technique to assess chewing function using two-coloured specimens: Validation and application. J Dent. 2015 Aug;43(8):955-64. doi: 10.1016/j.jdent.2015.06.003. Epub 2015 Jun 22.
PubMed 26111925Riera-Punet N, Martinez-Gomis J, Willaert E, Povedano M, Peraire M. Functional limitation of the masticatory system in patients with bulbar involvement in amyotrophic lateral sclerosis. J Oral Rehabil. 2018 Mar;45(3):204-210. doi: 10.1111/joor.12597. Epub 2017 Dec 30.
PubMed 29240971Khoury-Ribas L, Ayuso-Montero R, Rovira-Lastra B, Peraire M, Martinez-Gomis J. Reliability of a new test food to assess masticatory function. Arch Oral Biol. 2018 Mar;87:1-6. doi: 10.1016/j.archoralbio.2017.12.006. Epub 2017 Dec 9.
PubMed 29241026Martinez-Gomis J, Willaert E, Nogues L, Pascual M, Somoza M, Monasterio C. Five years of sleep apnea treatment with a mandibular advancement device. Side effects and technical complications. Angle Orthod. 2010 Jan;80(1):30-6. doi: 10.2319/030309-122.1.
PubMed 19852636Uniken Venema JAM, Doff MHJ, Joffe-Sokolova DS, Wijkstra PJ, van der Hoeven JH, Stegenga B, Hoekema A. Dental side effects of long-term obstructive sleep apnea therapy: a 10-year follow-up study. Clin Oral Investig. 2020 Sep;24(9):3069-3076. doi: 10.1007/s00784-019-03175-6. Epub 2019 Dec 20.
PubMed 31863188
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Side Effects of the Use of the Mandibular Advancement Device for Treatment of Obstructive Sleep Apnea on Dental Occlusion and Masticatory Function
- ClinicalTrials.gov ID
- NCT05420129
- Acronym / sponsor ID
- HOUB2021/039
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The researcher who would recruit the participants is not longer available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2032 (estimated)
- First posted
- 15 Jun 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.
This study evaluates the effect of the use of mandibular advancement devices (MAD) on dental occlusion and masticatory function during the first two years of obstructive sleep apnea (OSA) treatment.
52 participants diagnosed with obstructive sleep apnea will be studied, 26 will be treated with MAD and 26 participants will be treated with continuous positive airway pressure (CPAP) as a control group.
Participants will perform masticatory tests to assess masticatory performance in comminute and mixing capacity. Masticatory satisfaction perceived by the participants will be evaluated by questionnaires. Occlusal contact area and other occlusal characteristics will be assessed using occlusal silicone and T-Scan registrations and 3D digital models obtained with intraoral scan. Data collection will be performed before treatment with MAD or CPAP, and at 3, 6, 12, and 24 months from the start of treatment.
Detailed description
This prospective observational non-randomized clinical study aims to assess the effect of use MAD on masticatory performance. 52 subjects diagnosed with OSA will participate in this study divided into two different groups: 26 treated with MAD and 26 treated with CPAP. Data collection will be carried out before the start of treatment of the two modalities and at 3, 6, 12 and 24 months after starting the treatment. The intervention of the study will be based on execute chewing tests to evaluate masticatory performance from artificial food. Other aspects of matsticatory function would be also explored like subjective masticatory performance and jaw function limitation, dental position and occlusion, bite force or dental mobility. Artificial food tests will evaluate masticatory performance in comminute and mixing ability to determine the degree of reduction in masticatory performance produced by the use of MAD after 3 months of treatment. The main variable to be studied will be the median particle size of silicone tablets from Optozeta's test. This test is based on chewing 2 grams of silicone tablets inside a latex bag in order to evaluate their degree of comminution. The greater of grinded silicone, the greater of chewing performance. Another masticatory performance test will also be carried out is evaluation subject's mixing capacity with a two-colour chewing gum test. Degree of mixing of two colours of the gum will be checked after 40 chewing cycles. The more uniformity of the colour obtained, the more mixing ability the subject will demonstrate. A CPAP group control will be used, which will additionally allows us to know if this treatment has effects on dental position, occlusion and masticatory performance.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAD. Mandibular advancement Device | – | Device: MAD TherapyPatients diagnosed with Obstructive Sleep Apnea and treated with MAD |
| CPAP. Continuous Possitive Airway Pressure | – | Device: CPAP TherapyPatients diagnosed with Obstructive Sleep Apnea and treated with CPAP |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with sleep apnea and treated with CPAP or MAD
Key inclusion criteria (1 listed)
- Being diagnosed with OSA by polisomnography (IAH>15).
Key exclusion criteria (1 listed)
- Be treated with MAD or CPAP during more than 3 months in the lasts 5 years.
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 |
|---|---|---|
| MAD TherapyParticipants will be treated with a Mandibular Advancement Device therapy | Device | MAD. Mandibular advancement Device |
| CPAP TherapyParticipants will be treated with a Continuous Positive Airway Pressure therapy | Device | CPAP. Continuous Possitive Airway Pressure |
Primary outcome
Change in masticatory perfomance at 6 months
Time frame: Before treatment and 6 months after treatment
The masticatory performance will be evaluated by assessing the degree of comminution of the silicon test food (Median particle size). The particles from five trials (10 g) will be dried and passed through a series of eight sieves (0.25, 0.425, 0.85, 2, 2.8, 3.15, 4, and 5.6 mm) while being shaken for 6 min. Once the cumulative weight distribution of the sieve contents will be determined, the median particle size (MPS) will be calculated for each subject using the Rosin-Rammler equation [Qw (X) = 1 - 2E-(X/ X50)b], where Qw (X) is the fraction of particles by weight with a diameter smaller than X; X50 (or MPS) is the size of a theoretical sieve through which 50% of the weight would pass; and b describes the breadth of the particle size distribution. Therefore, the lower the MPS, the better the masticatory performance. Participants will perform masticatory tests before and 6 months after treatment.
Change in masticatory perfomance at 24 months
Time frame: Before treatment and 24 months after treatment
The masticatory performance will be evaluated by assessing the degree of comminution of the silicon test food (Median particle size). The particles from five trials (10 g) will be dried and passed through a series of eight sieves (0.25, 0.425, 0.85, 2, 2.8, 3.15, 4, and 5.6 mm) while being shaken for 6 min. Once the cumulative weight distribution of the sieve contents will be determined, the median particle size (MPS) will be calculated for each subject using the Rosin-Rammler equation [Qw (X) = 1 - 2E-(X/ X50)b], where Qw (X) is the fraction of particles by weight with a diameter smaller than X; X50 (or MPS) is the size of a theoretical sieve through which 50% of the weight would pass; and b describes the breadth of the particle size distribution. Therefore, the lower the MPS, the better the masticatory performance. Participants will perform masticatory tests before and 24 months after treatment.
24 secondary outcomes
Change in masticatory mixing ability at 6 months
Time frame: Before treatment and 6 months after treatment
Change in masticatory mixing ability at 24 months
Time frame: Before treatment and 24 months after treatment
Change in the degree of satisfaction in masticatory function at 6 months
Time frame: Before treatment and 6 months after treatment
Change in the degree of satisfaction in masticatory function at 24 months
Time frame: Before treatment and 24 months after treatment
Change in chewing ability at 6 months
Time frame: Before treatment and 6 months after treatment
Change in chewing ability at 24 months
Time frame: Before treatment and 24 months after treatment
Change in jaw functional limitation.at 6 months
Time frame: Before treatment and 6 months after treatment
Change in jaw functional limitation.at 24 months
Time frame: Before treatment and 24 months after treatment
Change in masticatory rhythm at 6 months
Time frame: Before treatment and 6 months after treatment
Change in masticatory rhythm at 24 months
Time frame: Before treatment and 24 months after treatment
Change in masticatory laterality at 6 months
Time frame: Before treatment and 6 months after treatment
Change in masticatory laterality at 24 months
Time frame: Before treatment and 24 months after treatment
Change in masticatory side-switch frequency at 6 months
Time frame: Before treatment and 6 months after treatment
Change in masticatory side-switch frequency at 24 months
Time frame: Before treatment and 24 months after treatment
Change in overjet at 6 months
Time frame: Before treatment and 6 months after treatment
Change in overjet at 24 months
Time frame: Before treatment and 24 months after treatment
Change in overbite at 6 months
Time frame: Before treatment and 6 months after treatment
Change in overbite at 24 months
Time frame: Before treatment and 24 months after treatment
Change in occlusal contact area at 6 months
Time frame: Before treatment and 6 months after treatment
Change in occlusal contact area at 24 months
Time frame: Before treatment and 24 months after treatment
Change in bite force at 6 months
Time frame: Before treatment and 6 months after treatment
Change in bite force at 24 months
Time frame: Before treatment and 24 months after treatment
Change in dental mobility at 6 months
Time frame: Before treatment and 6 months after treatment
Change in dental mobility at 24 months
Time frame: Before treatment and 24 months after treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Background: PubMed 31270888Ayuso-Montero R, Mariano-Hernandez Y, Khoury-Ribas L, Rovira-Lastra B, Willaert E, Martinez-Gomis J. Reliability and Validity of T-scan and 3D Intraoral Scanning for Measuring the Occlusal Contact Area. J Prosthodont. 2020 Jan;29(1):19-25. doi: 10.1111/jopr.13096. Epub 2019 Jul 21.
- Background: PubMed 26111925Schimmel M, Christou P, Miyazaki H, Halazonetis D, Herrmann FR, Muller F. A novel colourimetric technique to assess chewing function using two-coloured specimens: Validation and application. J Dent. 2015 Aug;43(8):955-64. doi: 10.1016/j.jdent.2015.06.003. Epub 2015 Jun 22.
- Background: PubMed 29240971Riera-Punet N, Martinez-Gomis J, Willaert E, Povedano M, Peraire M. Functional limitation of the masticatory system in patients with bulbar involvement in amyotrophic lateral sclerosis. J Oral Rehabil. 2018 Mar;45(3):204-210. doi: 10.1111/joor.12597. Epub 2017 Dec 30.
- Background: PubMed 29241026Khoury-Ribas L, Ayuso-Montero R, Rovira-Lastra B, Peraire M, Martinez-Gomis J. Reliability of a new test food to assess masticatory function. Arch Oral Biol. 2018 Mar;87:1-6. doi: 10.1016/j.archoralbio.2017.12.006. Epub 2017 Dec 9.
- Background: PubMed 19852636Martinez-Gomis J, Willaert E, Nogues L, Pascual M, Somoza M, Monasterio C. Five years of sleep apnea treatment with a mandibular advancement device. Side effects and technical complications. Angle Orthod. 2010 Jan;80(1):30-6. doi: 10.2319/030309-122.1.
- Background: PubMed 31863188Uniken Venema JAM, Doff MHJ, Joffe-Sokolova DS, Wijkstra PJ, van der Hoeven JH, Stegenga B, Hoekema A. Dental side effects of long-term obstructive sleep apnea therapy: a 10-year follow-up study. Clin Oral Investig. 2020 Sep;24(9):3069-3076. doi: 10.1007/s00784-019-03175-6. Epub 2019 Dec 20.
- Individual participant dataSharing planned: Yes. Data could be shared under a reasonable request
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Obstructive Sleep Apnea
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.
Eva Willaert, DDS PhD study director
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Mar 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 Spain. 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 was withdrawn before enrolling participants, so there are no results.
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 masticatory perfomance at 6 months (time frame: Before treatment and 6 months after treatment). 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 NCT05420129, which also lists 6 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 27 Mar 2025.