Implant Site ReactionNCT06226038
Effect of Static Magnetic Field on Dental Implant Stability.
A study testing Magnet disc and Stainless steel in people with Implant Site Reaction, run by Mahidol University at 1 site in Thailand.
Trial summary
To evaluate the effect of static magnetic field on dental implant to bone integration. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant Site Reaction
- What is being tested?
- Magnet disc and Stainless steel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy, complete edentulous area
Who cannot join
- uncontrolled NCDs patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Mahidol university
Bangkok, Payatai, 10400
Chayapong Supachatwong, PhD., +66909780204, chayapong.sup@mahidol.ac.th
Chayapong Supachatwong, PhD.
About this study
Official title: Effect of the Modified Magnetic Interim Denture on Dental Implant Stability and Marginal Bone Level: a Double-blind Randomized Controlled Trial Study
To evaluate the effect of static magnetic field on dental implant to bone integration.
Read the detailed description
Bone to implant integration depend on bone healing. Magnetic field was proved to promote and make bone to implant integration happen faster. We decided to investigate by placing 2 dental implants in lower jaw of complete edentulous patients with specialised temporary dentures. Said denture will have neodymium magnet on one side, completely embedded in acrylic mass.
- Conditions
- Implant Site Reaction
- Being tested
- Magnet disc, Stainless steel
- Keywords
- Static magnetic field, Dental implant, Bone healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnet discOther
Magnetic field promote proliferation and stimulate osteoblast differentiation
Stainless steelOther
For control
| Study group | Role | What they receive |
|---|---|---|
| With magnet | Experimental | Not described Receives: Other: Magnet disc |
| Without magnet | Sham comparator | Not described Receives: Other: Stainless steel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability quotient
Stability quantity of dental implant measured by resonance frequency analysis machine
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Site ReactionStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226038
- Sponsor's protocol ID
- COA. MURA2023/919
- Status last verified
- May 2024
- First submitted
- 17 Jan 2024
- Last updated
- 16 May 2024
- Results posted
- No
- 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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Modified Magnetic Interim Denture on Dental Implant Stability and Marginal Bone Level: a Double-blind Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT06226038
- Acronym / sponsor ID
- COA. MURA2023/919
- Conditions
- Implant Site Reaction
- Keywords
- Static magnetic field, Dental implant, Bone healing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jan 2024 (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.
To evaluate the effect of static magnetic field on dental implant to bone integration.
Detailed description
Bone to implant integration depend on bone healing. Magnetic field was proved to promote and make bone to implant integration happen faster. We decided to investigate by placing 2 dental implants in lower jaw of complete edentulous patients with specialised temporary dentures. Said denture will have neodymium magnet on one side, completely embedded in acrylic mass.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With magnet | Experimental | Other: Magnet disc |
| Without magnet | Sham comparator | Other: Stainless steel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy, complete edentulous area
Key exclusion criteria (1 listed)
- uncontrolled NCDs patients
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 |
|---|---|---|
| Magnet discMagnetic field promote proliferation and stimulate osteoblast differentiation | Other | With magnet |
| Stainless steelFor control | Other | Without magnet |
Primary outcome
Implant stability quotient
Time frame: 90 days
Stability quantity of dental implant measured by resonance frequency analysis machine
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnet disc and Stainless steel in people with Implant Site Reaction, run by Mahidol University at 1 site in Thailand.
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: looking for participants now, as of the sponsor's last update on 16 May 2024. 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 Thailand. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant stability quotient (time frame: 90 days). 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 16 May 2024.