Maxillary Class III Modification I Edentulous PatientsNCT03507153
Muscle Activity Evaluation of Maxillary Bilateral Bounded Partial Denture Fabricated By Bre-Flex Versus Peek
A study testing Bre-flex maxillary partial denture and PEEK maxillary partial denture in people with Maxillary Class III Modification I Edentulous Patients, run by Cairo University.
Trial summary
Evaluation of the muscle activity of masseter in tooth borne partial denture wearers (class III modification 1 Kennedy's classification) with two different denture base materials (Breflex and PEEK) by means of electromyograph. Read more about this study
- Who is it for?
- Ages 45 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Class III Modification I Edentulous Patients
- What is being tested?
- Bre-flex maxillary partial denture and PEEK maxillary partial denture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 1 Sep 2018
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patients must have Kennedy class III modification I upper partially edentulous ridges.
- The remaining teeth have good periodontal condition, with no signs of attrition or gingival recession.
- All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient interarch distance.
- Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
- Free from any tempro-mandibular joint disorder.
- The patients have good oral hygiene and low caries index.
Who cannot join
- Patients having abnormal habits as bruxism or clenching.
- Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included.
- Teeth with compromised bone support.
- Patient with xerostomia or excessive salivation.
- Patient with abnormal tongue behavior and/or size.
About this study
Official title: Muscle Activity Evaluation of Maxillary Bilateral Bounded Partial Denture Fabricated By Bre-Flex Versus Peek (Randomized Clinical Trial)
Evaluation of the muscle activity of masseter in tooth borne partial denture wearers (class III modification 1 Kennedy's classification) with two different denture base materials (Breflex and PEEK) by means of electromyograph.
- Being tested
- Bre-flex maxillary partial denture, PEEK maxillary partial denture
- Keywords
- "Nylon denture base" and "PEEK partial denture"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bre-flex maxillary partial dentureProcedure or surgery
Partial denture fabricated from Bre.flex material.
PEEK maxillary partial dentureProcedure or surgery
Partial denture fabricated from PEEK material.
| Study group | Role | What they receive |
|---|---|---|
| Bre-fllex group | Active comparator | Maxillary class III modification I edentulous patients that will recieve Bre-flex partial denture Receives: Procedure: Bre-flex maxillary partial denture |
| PEEK group | Experimental | Maxillary class III modification I edentulous patients that will recieve PEEK partial denture Receives: Procedure: PEEK maxillary partial denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular activity
Evaluation of the muscle activity of masseter in tooth borne partial denture wearers (class III modification 1 Kennedy's classification) with two different denture base materials (Breflex and PEEK) by means of electromyograph.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start1 May 2018 (estimated)
- Primary completion1 Aug 2018 (estimated)
- Study completion1 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Class III Modification I Edentulous PatientsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed salama sayed tantawy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507153
- Sponsor's protocol ID
- ASalama
- Status last verified
- Apr 2018
- First submitted
- 23 Mar 2018
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Activity Evaluation of Maxillary Bilateral Bounded Partial Denture Fabricated By Bre-Flex Versus Peek (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03507153
- Acronym / sponsor ID
- ASalama
- Keywords
- "Nylon denture base" and "PEEK partial denture"
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 24 Apr 2018 (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.
Evaluation of the muscle activity of masseter in tooth borne partial denture wearers (class III modification 1 Kennedy's classification) with two different denture base materials (Breflex and PEEK) by means of electromyograph.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bre-fllex group | Active comparator | Procedure: Bre-flex maxillary partial dentureMaxillary class III modification I edentulous patients that will recieve Bre-flex partial denture |
| PEEK group | Experimental | Procedure: PEEK maxillary partial dentureMaxillary class III modification I edentulous patients that will recieve PEEK partial denture |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- All patients must have Kennedy class III modification I upper partially edentulous ridges.
- The remaining teeth have good periodontal condition, with no signs of attrition or gingival recession.
- All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient interarch distance.
- Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
- Free from any tempro-mandibular joint disorder.
Key exclusion criteria (5 listed)
- Patients having abnormal habits as bruxism or clenching.
- Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included.
- Teeth with compromised bone support.
- Patient with xerostomia or excessive salivation.
- Patient with abnormal tongue behavior and/or size.
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 |
|---|---|---|
| Bre-flex maxillary partial denturePartial denture fabricated from Bre.flex material. | Procedure or surgery | Bre-fllex group |
| PEEK maxillary partial denturePartial denture fabricated from PEEK material. | Procedure or surgery | PEEK group |
Primary outcome
Muscular activity
Time frame: one month
Evaluation of the muscle activity of masseter in tooth borne partial denture wearers (class III modification 1 Kennedy's classification) with two different denture base materials (Breflex and PEEK) by means of electromyograph.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing Bre-flex maxillary partial denture and PEEK maxillary partial denture in people with Maxillary Class III Modification I Edentulous Patients, run by Cairo University.
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 5 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 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Muscular activity (time frame: one month). 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 Apr 2018.