Clinical Study of Activa Bioactive RestorativeNCT04281433
Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner
A study testing Activa Bioactive in people with Clinical Study of Activa Bioactive Restorative and Dental Caries, run by Al-Azhar University at 1 site in Egypt.
Trial summary
electromyographic activity as well as clinical performance of bulk-Fill composite resins with Activa Bioactive Liner Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Study of Activa Bioactive Restorative, Dental Caries
- What is being tested?
- Activa Bioactive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 1 Feb 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients between the ages of 18-40 years and cooperative patient.
- Good oral hygiene.
- Normal occlusal relation with normal dentition.
Who cannot join
- Patient with severe medical problems.
- Tenderness with percussion or pre-operative pulpal pain.
- Mobile tooth and tooth with gingival recession.
- Pregnant or lactating females.
- Cracked teeth or teeth with deep periodontal pockets.
- Tooth with previous restoration.
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- Allergy to resin materials.
- Defective restorations adjacent or opposing to tooth.
- Patient with bruxism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electromicrographic Activity as Well as Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner
electromyographic activity as well as clinical performance of bulk-Fill composite resins with Activa Bioactive Liner
- Being tested
- Activa Bioactive
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activa BioactiveOther
Before cavity preparation and restoration, masticatory muscles activity will be evaluated by using electromyography. An electromyography detects the electrical potential generated by muscle cells. A total of 40 posterior teeth will be selected for this study and grouped into 2 main groups (20 for each group)) according to presence of caries in one or both side in patient (unilateral or bilateral). Split mouth technique will be used. The affected teeth will be treated by removing the caries and restored tooth with bulk fill composite material, after restoring the affected teeth. Masticatory muscles activity will be evaluated by using electromyography to detect any changes in masticatory muscles activity before and after restoration.
| Study group | Role | What they receive |
|---|---|---|
| unilateral | Experimental | Not described Receives: Other: Activa Bioactive |
| bilateral | Experimental | Not described Receives: Other: Activa Bioactive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyographic activity
An electromyography detects the electrical potential generated by muscle cells. When these cells are electrically activated, the signals can be analyzed to detect medical Abnormalities, activation level, or recruitment order, or to analyze the biomechanics of human movement
Measured: baseline (immediate)
Electromyographic activity
An electromyography detects the electrical potential generated by muscle cells. When these cells are electrically activated, the signals can be analyzed to detect medical Abnormalities, activation level, or recruitment order, or to analyze the biomechanics of human movement
Measured: one week
Electromyographic activity
An electromyography detects the electrical potential generated by muscle cells. When these cells are electrically activated, the signals can be analyzed to detect medical Abnormalities, activation level, or recruitment order, or to analyze the biomechanics of human movement
Measured: after three months
Electromyographic activity
An electromyography detects the electrical potential generated by muscle cells. When these cells are electrically activated, the signals can be analyzed to detect medical Abnormalities, activation level, or recruitment order, or to analyze the biomechanics of human movement
Measured: after six months
Secondary outcomes (1)
Survival rate of restorative material
USPHS criteria
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start1 Oct 2019
- Primary completion1 Dec 2019
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Study of Activa Bioactive RestorativeStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ibrahim Ahmed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281433
- Sponsor's protocol ID
- REC16-051
- Status last verified
- Feb 2020
- First submitted
- 11 Feb 2020
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromicrographic Activity as Well as Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner
- ClinicalTrials.gov ID
- NCT04281433
- Acronym / sponsor ID
- REC16-051
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 24 Feb 2020 (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.
electromyographic activity as well as clinical performance of bulk-Fill composite resins with Activa Bioactive Liner
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unilateral | Experimental | Other: Activa Bioactive |
| bilateral | Experimental | Other: Activa Bioactive |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients between the ages of 18-40 years and cooperative patient.
- Good oral hygiene.
- Normal occlusal relation with normal dentition.
Key exclusion criteria (9 listed)
- Patient with severe medical problems.
- Tenderness with percussion or pre-operative pulpal pain.
- Mobile tooth and tooth with gingival recession.
- Pregnant or lactating females.
- Cracked teeth or teeth with deep periodontal pockets.
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 |
|---|---|---|
| Activa BioactiveBefore cavity preparation and restoration, masticatory muscles activity will be evaluated by using electromyography. An electromyography detects the electrical potential generated by muscle cells. A total of 40 posterior teeth will be selected for this study and grouped into 2 main groups (20 for each group)) according to presence of caries in one or both side in patient (unilateral or bilateral). Split mouth technique will be used. The affected teeth will be treated by removing the caries and restored tooth with bulk fill composite material, after restoring the affected teeth. Masticatory muscles activity will be evaluated by using electromyography to detect any changes in masticatory muscles activity before and after restoration. | Other | bilateral, unilateral |
Primary outcome
Electromyographic activity
Time frame: baseline (immediate)
An electromyography detects the electrical potential generated by muscle cells. When these cells are electrically activated, the signals can be analyzed to detect medical Abnormalities, activation level, or recruitment order, or to analyze the biomechanics of human movement
Electromyographic activity
Time frame: one week
An electromyography detects the electrical potential generated by muscle cells. When these cells are electrically activated, the signals can be analyzed to detect medical Abnormalities, activation level, or recruitment order, or to analyze the biomechanics of human movement
Electromyographic activity
Time frame: after three months
An electromyography detects the electrical potential generated by muscle cells. When these cells are electrically activated, the signals can be analyzed to detect medical Abnormalities, activation level, or recruitment order, or to analyze the biomechanics of human movement
Electromyographic activity
Time frame: after six months
An electromyography detects the electrical potential generated by muscle cells. When these cells are electrically activated, the signals can be analyzed to detect medical Abnormalities, activation level, or recruitment order, or to analyze the biomechanics of human movement
1 secondary outcome
Survival rate of restorative material
Time frame: six months
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 24 Feb 2020.
- Individual participant dataSharing planned: Undecided
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 Activa Bioactive in people with Clinical Study of Activa Bioactive Restorative and Dental Caries, run by Al-Azhar University 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 9 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 24 Feb 2020. 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?
Electromyographic activity (time frame: baseline (immediate)). The study lists 4 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 24 Feb 2020.