Temporomandibular DisordersNCT02015585
Evaluation of Influence of Two Treatment Protocols on Mandibular Movements and Condyle-fossa Relation
A study testing interocclusal appliance, Relining of the complete dentures and Complete denture rehabilitation in people with Temporomandibular Disorders, run by Federal University of Pelotas at 1 site in Brazil.
Trial summary
The edentulism and use of inadequate dentures, unstable and with teeth worn because long period of usage can lead to an disharmony of the stomatognathic system due to gradual loss of occlusion vertical dimension resulting in inadequate mandibular movements and condyle-fossa relation. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorders
- What is being tested?
- interocclusal appliance, Relining of the complete dentures and Complete denture rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2013to Dec 2017
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults suffering from upper and lower denture indicated for replacement due to use exceeding five years;
- Have availability to attend FO / UFPel days predetermined;
- Agree with the term informed consent, approved by the research ethics committee of FO / UFPel.
Who cannot join
- Patients younger than 40 years;
- Patients who are not users of denture upper and lower;
- Patients denture wearers during periods of less than five years.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Dentistry, Federal University of Pelotas
Pelotas, Rio Grande do Sul, 96015-560
About this study
Official title: Evaluation of Mandibular Movements and Condyle-fossa Relation From Two Treatment Protocols. A Randomized Clinical Trial.
The edentulism and use of inadequate dentures, unstable and with teeth worn because long period of usage can lead to an disharmony of the stomatognathic system due to gradual loss of occlusion vertical dimension resulting in inadequate mandibular movements and condyle-fossa relation. The reline of the denture base and the use of interocclusal appliance prior to definitive rehabilitation could have influence on these functional aspects. However, there are not Randomized Controlled clinical Trials (RCTs) testing the combined use of these two treatments in reestablishing these functional aspects. The, aim of this study is to evaluate whether the denture base reline and the use of interocclusal appliance prior to final rehabilitation have influence on mandibular movements and condyle-fossa relation, incomplete denture wearers. For this controlled, crossover, randomized and blinded clinical trial, 30 volunteers, totally edentulous, complete denture wearer over a period of five year, will be selected. The volunteers will be randomly allocated into three subgroups (n= 10) and will receive the following treatments: Control (C)Volunteers will receive new complete denture without any previous intervention in their old complete denture; Relining Denture (RD)Volunteers will be submitted to the relining of the base of the their old complete denture and after 30 days of usage and before the replacement of the new complete denture, an evaluation will be performed; Interocclusal Appliance (IA) Volunteers will be submitted to the treatment with interocclusal appliance and after 30 days of usage and before the replacement of the new complete denture, an evaluation will be performed. Volunteers will be evaluated regarding the extent of mandibular movement by intraoral record of Gothic Gysi arch; condyle-fossa relation by cone-bean computed tomographic scan; occlusion vertical dimension by Willis compass and photographic record. These evaluations will be performed at three periods, T0 baseline; T1 after application of randomized treatment, reline denture and interocclusal appliance); T3 after final rehabilitation. The control group will be evaluated only at periods T0 and T3.
- Conditions
- Temporomandibular Disorders
- Being tested
- interocclusal appliance, Relining of the complete dentures, Complete denture rehabilitation
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interocclusal applianceProcedure or surgery
Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.
Relining of the complete denturesProcedure or surgery
Patients will be submitted to the relining of their old dentures 30 days before the replacement of their complete dentures.
Complete denture rehabilitationProcedure or surgery
All patients will be rehabilitated with new complete dentures in the study
| Study group | Role | What they receive |
|---|---|---|
| Interocclusal appliance | Experimental | Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures. Receives: Procedure: interocclusal appliance; Procedure: Complete denture rehabilitation |
| Relining complete denture base | Experimental | Patients will be submitted to a procedure of relining their old dentures 30 days before the replacement of the complete dentures. Receives: Procedure: Relining of the complete dentures; Procedure: Complete denture rehabilitation |
| Only Rehabilitation | Active comparator | Patients will be treated with a complete denture without any kind of previous intervention Receives: Procedure: Complete denture rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the occlusal vertical dimension after treatment at 6 months
Measured: 30 days after randomization; and 30 days after final prosthetic rehabilitation
Secondary outcomes (1)
Change from baseline in the extension of the mandibular movements up to 6 months.
The extent of mandibular movement will be assessed by intramural record of Gothic Gysi arch.
Measured: 30 days after randomization; and 30 days after the final prosthetic rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2015
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisordersStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximiliano Sergio Cenci, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015585
- Sponsor's protocol ID
- PPGO0014
- Status last verified
- Apr 2017
- First submitted
- 13 Sep 2013
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mandibular Movements and Condyle-fossa Relation From Two Treatment Protocols. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02015585
- Acronym / sponsor ID
- PPGO0014
- Conditions
- Temporomandibular Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 19 Dec 2013 (estimated)
- 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 edentulism and use of inadequate dentures, unstable and with teeth worn because long period of usage can lead to an disharmony of the stomatognathic system due to gradual loss of occlusion vertical dimension resulting in inadequate mandibular movements and condyle-fossa relation. The reline of the denture base and the use of interocclusal appliance prior to definitive rehabilitation could have influence on these functional aspects. However, there are not Randomized Controlled clinical Trials (RCTs) testing the combined use of these two treatments in reestablishing these functional aspects. The, aim of this study is to evaluate whether the denture base reline and the use of interocclusal appliance prior to final rehabilitation have influence on mandibular movements and condyle-fossa relation, incomplete denture wearers. For this controlled, crossover, randomized and blinded clinical trial, 30 volunteers, totally edentulous, complete denture wearer over a period of five year, will be selected. The volunteers will be randomly allocated into three subgroups (n= 10) and will receive the following treatments: Control (C)Volunteers will receive new complete denture without any previous intervention in their old complete denture; Relining Denture (RD)Volunteers will be submitted to the relining of the base of the their old complete denture and after 30 days of usage and before the replacement of the new complete denture, an evaluation will be performed; Interocclusal Appliance (IA) Volunteers will be submitted to the treatment with interocclusal appliance and after 30 days of usage and before the replacement of the new complete denture, an evaluation will be performed. Volunteers will be evaluated regarding the extent of mandibular movement by intraoral record of Gothic Gysi arch; condyle-fossa relation by cone-bean computed tomographic scan; occlusion vertical dimension by Willis compass and photographic record. These evaluations will be performed at three periods, T0 baseline; T1 after application of randomized treatment, reline denture and interocclusal appliance); T3 after final rehabilitation. The control group will be evaluated only at periods T0 and T3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interocclusal appliance | Experimental | Procedure: interocclusal appliance, Procedure: Complete denture rehabilitationPatients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures. |
| Relining complete denture base | Experimental | Procedure: Relining of the complete dentures, Procedure: Complete denture rehabilitationPatients will be submitted to a procedure of relining their old dentures 30 days before the replacement of the complete dentures. |
| Only Rehabilitation | Active comparator | Procedure: Complete denture rehabilitationPatients will be treated with a complete denture without any kind of previous intervention |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adults suffering from upper and lower denture indicated for replacement due to use exceeding five years;
- Have availability to attend FO / UFPel days predetermined;
- Agree with the term informed consent, approved by the research ethics committee of FO / UFPel.
Key exclusion criteria (3 listed)
- Patients younger than 40 years;
- Patients who are not users of denture upper and lower;
- Patients denture wearers during periods of less than five 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 |
|---|---|---|
| interocclusal appliancePatients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures. | Procedure or surgery | Interocclusal appliance |
| Relining of the complete denturesPatients will be submitted to the relining of their old dentures 30 days before the replacement of their complete dentures. | Procedure or surgery | Relining complete denture base |
| Complete denture rehabilitationAll patients will be rehabilitated with new complete dentures in the study | Procedure or surgery | Interocclusal appliance, Only Rehabilitation, Relining complete denture base |
Primary outcome
Change from baseline of the occlusal vertical dimension after treatment at 6 months
Time frame: 30 days after randomization; and 30 days after final prosthetic rehabilitation
1 secondary outcome
Change from baseline in the extension of the mandibular movements up to 6 months.
Time frame: 30 days after randomization; and 30 days after the final prosthetic rehabilitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interocclusal appliance, Relining of the complete dentures and Complete denture rehabilitation in people with Temporomandibular Disorders, run by Federal University of Pelotas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2017. 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 Brazil. 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?
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 from baseline of the occlusal vertical dimension after treatment at 6 months (time frame: 30 days after randomization; and 30 days after final prosthetic rehabilitation). 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 6 Apr 2017.