OcclusionNCT05949151
Occlusal Forces and Muscle Activity in Fixed Versus Removable Mandibular Implant Supported Overdenture
A study testing dental implants (K1 line conical connection double thread, OXY, Italy), Occlusense (Bausch GmbH & Co. KG) and electromyography (EMG) (Nemus II)". in people with Occlusion, run by Asmaa Nabil Elboraey at 1 site in Egypt.
Trial summary
22 Patients having lower completely edentulous mandible aged 55-60 years were selected from the outpatient dental clinic of the Medical Excellence Centre of the National Research (NRC) Cairo, Egypt. Six dental implants were inserted in the mandible of each patient. Read more about this study
- Who is it for?
- Ages 55 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Occlusion
- What is being tested?
- dental implants (K1 line conical connection double thread, OXY, Italy), Occlusense (Bausch GmbH & Co. KG) and electromyography (EMG) (Nemus II)".
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 May 2023
- 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 55 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- edentulous mandible with well-developed alveolar ridge
- free from temporomandibular joint disorder
- free from any chronic diseases.
Who cannot join
- smoker
- patients having systemically immunosuppressive diseases
- patients receiving radiotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
22 Patients having lower completely edentulous mandible aged 55-60 years were selected from the outpatient dental clinic of the Medical Excellence Centre of the National Research (NRC) Cairo, Egypt. Six dental implants were inserted in the mandible of each patient.
The patients were randomly categorized into two groups according to the final restoration.
Read the detailed description
Group I: received a complete removable mandibular implant supported overdenture. While Group II: received implant supported fixed bridge.
Occlusal equilibrations, Muscle activities, and oral health-related quality of life (OHRQoL) were assessed by at the time of prosthesis insertion, after one and three month.
- Conditions
- Occlusion
- Being tested
- dental implants (K1 line conical connection double thread, OXY, Italy), Occlusense (Bausch GmbH & Co. KG), electromyography (EMG) (Nemus II)"., oral health-related quality of life (OHRQoL)
- Keywords
- implant supported overdenture, muscle activity
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implants (K1 line conical connection double thread, OXY, Italy)Procedure or surgery
Six dental implants inserted on the edentulous mandible
Occlusense (Bausch GmbH & Co. KG)Device
sensor used to evaluate the equilibration of occlusal forces.
electromyography (EMG) (Nemus II)".Device
Also called Assessment of Muscle Activity by electromyography (EMG) (Nemus II)
EMG recordings were accomplished by a computer electromyography-based data acquisition system
oral health-related quality of life (OHRQoL)Other
Oral Health-related Quality of Life (OHRQoL) was estimated by employing the Oral Health Impact Profile questionnaire which comprises nineteen multiple questions that were translated into Arabic.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Patients received a complete removable mandibular implant supported overdenture Receives: Procedure: dental implants (K1 line conical connection double thread, OXY, Italy); Device: Occlusense (Bausch GmbH & Co. KG); Device: electromyography (EMG) (Nemus II)".; Other: oral health-related quality of life (OHRQoL) |
| Group II | Active comparator | Patients received implant supported fixed bridge Receives: Procedure: dental implants (K1 line conical connection double thread, OXY, Italy); Device: Occlusense (Bausch GmbH & Co. KG); Device: electromyography (EMG) (Nemus II)".; Other: oral health-related quality of life (OHRQoL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusal equilibrations
assessed by Occlusense device
Measured: Day 1 , one month and 3 month
Muscle activities
assessed by Electromyograph (EMG) device
Measured: Day 1 , one month and 3 month
Secondary outcomes (1)
oral health-related quality of life (OHRQoL)
Oral Health-related Quality of Life questionnaire
Measured: Day 1, one month and 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Jan 2023
- Primary completion1 Mar 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OcclusionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- two group Group I: received a complete removable mandibular implant supported overdenture. While Group II: received implant supported fixed bridge.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asmaa Nabil Elboraey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asmaa Nabil Elboraey, National Research Centre, Egypt
- Investigators
- Asmaa Elboraey, Ass.Prof, Principal investigator, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949151
- Sponsor's protocol ID
- 14312012023
- Status last verified
- Jul 2023
- First submitted
- 30 Jun 2023
- Last updated
- 17 Jul 2023
- 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 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occlusal Forces and Muscle Activity in Fixed Versus Removable Mandibular Implant Supported Overdenture
- ClinicalTrials.gov ID
- NCT05949151
- Acronym / sponsor ID
- 14312012023
- Conditions
- Occlusion
- Keywords
- implant supported overdenture, muscle activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Asmaa Nabil ElboraeyUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 17 Jul 2023 (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.
22 Patients having lower completely edentulous mandible aged 55-60 years were selected from the outpatient dental clinic of the Medical Excellence Centre of the National Research (NRC) Cairo, Egypt. Six dental implants were inserted in the mandible of each patient.
The patients were randomly categorized into two groups according to the final restoration.
Detailed description
Group I: received a complete removable mandibular implant supported overdenture. While Group II: received implant supported fixed bridge.
Occlusal equilibrations, Muscle activities, and oral health-related quality of life (OHRQoL) were assessed by at the time of prosthesis insertion, after one and three month.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- two group Group I: received a complete removable mandibular implant supported overdenture. While Group II: received implant supported fixed bridge.
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Procedure: dental implants (K1 line conical connection double thread, OXY, Italy), Device: Occlusense (Bausch GmbH & Co. KG), Device: electromyography (EMG) (Nemus II)"., Other: oral health-related quality of life (OHRQoL)Patients received a complete removable mandibular implant supported overdenture |
| Group II | Active comparator | Procedure: dental implants (K1 line conical connection double thread, OXY, Italy), Device: Occlusense (Bausch GmbH & Co. KG), Device: electromyography (EMG) (Nemus II)"., Other: oral health-related quality of life (OHRQoL)Patients received implant supported fixed bridge |
Who may qualify
- Ages
- 55 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- edentulous mandible with well-developed alveolar ridge
- free from temporomandibular joint disorder
- free from any chronic diseases.
Key exclusion criteria (3 listed)
- smoker
- patients having systemically immunosuppressive diseases
- patients receiving radiotherapy.
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 |
|---|---|---|
| dental implants (K1 line conical connection double thread, OXY, Italy)Six dental implants inserted on the edentulous mandible | Procedure or surgery | Group I, Group II |
| Occlusense (Bausch GmbH & Co. KG)sensor used to evaluate the equilibration of occlusal forces. | Device | Group I, Group II |
| electromyography (EMG) (Nemus II)".Also: Assessment of Muscle Activity by electromyography (EMG) (Nemus II)EMG recordings were accomplished by a computer electromyography-based data acquisition system | Device | Group I, Group II |
| oral health-related quality of life (OHRQoL)Oral Health-related Quality of Life (OHRQoL) was estimated by employing the Oral Health Impact Profile questionnaire which comprises nineteen multiple questions that were translated into Arabic. | Other | Group I, Group II |
Primary outcome
Occlusal equilibrations
Time frame: Day 1 , one month and 3 month
assessed by Occlusense device
Muscle activities
Time frame: Day 1 , one month and 3 month
assessed by Electromyograph (EMG) device
1 secondary outcome
oral health-related quality of life (OHRQoL)
Time frame: Day 1, one month and 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- 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.
Asmaa Elboraey, Ass.Prof principal investigator
National Research Centre, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dental implants (K1 line conical connection double thread, OXY, Italy), Occlusense (Bausch GmbH & Co. KG) and electromyography (EMG) (Nemus II)". in people with Occlusion, run by Asmaa Nabil Elboraey at 1 site in Egypt.
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: finished, as of the sponsor's last update on 17 Jul 2023. 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 Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occlusal equilibrations (time frame: Day 1 , one month and 3 month). 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?
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 17 Jul 2023.