Peri-implantitisPhase 3NCT01972399
Laser Therapy Treatment of Peri-implantitis.
A Phase 3 study testing Laser and Mechanical debridement in people with Peri-implantitis, run by University of Michigan at 1 site in United States.
Trial summary
The primary objective of this study is to compare the clinical outcomes of using Er: YAG laser along with bone graft and barrier membrane to conventional mechanical debridement also with bone graft and barrier membrane in the treatment of peri-implantitis infections. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implantitis
- What is being tested?
- Laser and Mechanical debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Apr 2017
- Phase
- Phase 3
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients, aged 18 - 85 years
- Physical status according to the American Society of Anesthesiologists (ASA) I or II, which includes patients who are systemically healthy or suffer under mild to moderate, but well controlled systemic diseases.
- Patients having a minimum of 1 dental implant with peri-implantitis.
- The dental implant with peri-implantitis has ≥ 3 threads exposed or pocket probing depth (PPD) ≥ 5mm, with bleeding on probing (BOP) and/or suppuration (pus).
- The implants are in function for at least 6 months
- No uncontrolled systemic disease or condition known to alter bone metabolism, like Osteoporosis, Osteopenia, Hyperparathyroidism, Paget's disease.
- Only rough surface implant will be included in this study
Who cannot join
- Long-term use of antibiotics > 2 weeks in the past two months
- No peri-implantitis treatment in the last 2 months
- Patients taking medications known to modify bone metabolism (such as bisphosphonates, corticosteroids, Hormone replacement therapy for menopausal women, Parathyroid hormone, Denosumab, strontium ranelate).
- Pregnant females or those planning to become pregnant.
- Patients with a history of medically diagnosed oral cancer, bisphosphonate usage, Sepsis or those having adverse outcomes to oral procedures in the past, will be excluded
- Mobility of dental implants
Show all 12Show fewer
- History of alcoholism or drug abuse
- Current smokers or quit smoking less than 6 months
- Diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes (HbA1c >7)
- Patients with allergies known to affect one or more of the treatment provided in this study
- Polish surface implants
- Implants with trabecular surface
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109
About this study
Official title: Influence of Laser Therapy Upon Surgical Treatment of Peri-implantitis Lesions.
The primary objective of this study is to compare the clinical outcomes of using Er: YAG laser along with bone graft and barrier membrane to conventional mechanical debridement also with bone graft and barrier membrane in the treatment of peri-implantitis infections.
- Conditions
- Peri-implantitis
- Being tested
- Laser, Mechanical debridement
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserProcedure or surgery
This is a surgery that the patient will undergo and the laser will be used to clean the surface of the implant.
Mechanical debridementProcedure or surgery
This is a surgery that the patient will undergo to have the surface of the implant cleaned using hand instruments.
| Study group | Role | What they receive |
|---|---|---|
| Laser | Experimental | A laser will be used to clean out the area around the diseased implant to try to regain bone. Receives: Procedure: Laser |
| Mechanical | Active comparator | Mechanical debridement will be used to clean out the area around the diseased implant to try to regain bone. Receives: Procedure: Mechanical debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perio Probing Depth
Measured: Change in probing depth from beginning of study to 6 months after intervention
Secondary outcomes (1)
Bleeding on Probing
Measured: Change in bleeding on probing from beginning of study to 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startJan 2016
- Primary completionApr 2017 (estimated)
Why it stopped: Withdrawn from IRB at PI's request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implantitisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Hom-Lay Wang, University of Michigan
- Investigators
- Fernando Suarez, DDS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972399
- Sponsor's protocol ID
- HUM00077816
- Status last verified
- Apr 2015
- First submitted
- 7 Oct 2013
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Laser Therapy Upon Surgical Treatment of Peri-implantitis Lesions.
- ClinicalTrials.gov ID
- NCT01972399
- Acronym / sponsor ID
- HUM00077816
- Conditions
- Peri-implantitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn from IRB at PI's request
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Apr 2017 (estimated)
- First posted
- 30 Oct 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 primary objective of this study is to compare the clinical outcomes of using Er: YAG laser along with bone graft and barrier membrane to conventional mechanical debridement also with bone graft and barrier membrane in the treatment of peri-implantitis infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser | Experimental | Procedure: LaserA laser will be used to clean out the area around the diseased implant to try to regain bone. |
| Mechanical | Active comparator | Procedure: Mechanical debridementMechanical debridement will be used to clean out the area around the diseased implant to try to regain bone. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients, aged 18 - 85 years
- Physical status according to the American Society of Anesthesiologists (ASA) I or II, which includes patients who are systemically healthy or suffer under mild to moderate, but well controlled systemic diseases.
- Patients having a minimum of 1 dental implant with peri-implantitis.
- The dental implant with peri-implantitis has ≥ 3 threads exposed or pocket probing depth (PPD) ≥ 5mm, with bleeding on probing (BOP) and/or suppuration (pus).
- The implants are in function for at least 6 months
Key exclusion criteria (12 listed)
- Long-term use of antibiotics > 2 weeks in the past two months
- No peri-implantitis treatment in the last 2 months
- Patients taking medications known to modify bone metabolism (such as bisphosphonates, corticosteroids, Hormone replacement therapy for menopausal women, Parathyroid hormone, Denosumab, strontium ranelate).
- Pregnant females or those planning to become pregnant.
- Patients with a history of medically diagnosed oral cancer, bisphosphonate usage, Sepsis or those having adverse outcomes to oral procedures in the past, will be excluded
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 |
|---|---|---|
| LaserThis is a surgery that the patient will undergo and the laser will be used to clean the surface of the implant. | Procedure or surgery | Laser |
| Mechanical debridementThis is a surgery that the patient will undergo to have the surface of the implant cleaned using hand instruments. | Procedure or surgery | Mechanical |
Primary outcome
Perio Probing Depth
Time frame: Change in probing depth from beginning of study to 6 months after intervention
1 secondary outcome
Bleeding on Probing
Time frame: Change in bleeding on probing from beginning of study to 6 months after intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
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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.
Fernando Suarez, DDS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laser and Mechanical debridement in people with Peri-implantitis, run by University of Michigan at 1 site in United States.
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 7 inclusion and 12 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: withdrawn, as of the sponsor's last update on 3 Apr 2015. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Perio Probing Depth (time frame: Change in probing depth from beginning of study to 6 months after intervention). 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 3 Apr 2015.