ImplantNCT02362854
Efficacy of Diode Laser in Peri-implantitis
A study testing Conventional peri-implantitis treatment and DL application in peri-implantitis in people with Implant and Peri-Implantitis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare the efficacy of a diode laser (DL) as an adjunct to conventional scaling in the treatment of mild-to-moderate peri-implantitis. A prospective clinical, radiographic and microbiologic split-mouth study was conducted to test the following null hypothesis; adjunct application of a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant, Peri-Implantitis, Alveolar Bone Loss
- What is being tested?
- Conventional peri-implantitis treatment and DL application in peri-implantitis
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2010to Jul 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
- No local and systemic health problems prohibit the study interventions
- Bi-lateral implants with peri-implantitis diagnosis
Who cannot join
- Local and systemic health problems prohibiting the study interventions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Oral Implantology, Faculty of Dentistry, Istanbul University
Istanbul, Capa, 34093
About this study
Official title: A Randomized Clinical Trial of an Adjunct Diode Laser Application in the Treatment of Peri-implantitis.
The aim of this study was to compare the efficacy of a diode laser (DL) as an adjunct to conventional scaling in the treatment of mild-to-moderate peri-implantitis. A prospective clinical, radiographic and microbiologic split-mouth study was conducted to test the following null hypothesis; adjunct application of a diode laser, in the conventional treatment of peri-implantitis, are not associated with a statistically significant difference regarding the microbial counts, marginal bone loss and peri-implant parameters.
Read the detailed description
Efficacy of a diode laser (DL) in peri-implantitis was investigated. 48 implants diagnosed with peri-implantitis were included. In addition to the conventional scaling and debridement, random 24 implants were lased by a DL. Periodontal indexes, microbiologic specimens and radiographs were used for assessment. Baseline parameters were similar between groups. After six months laser group revealed higher MBL than the control group. Microbiota of the implants were found unchanged after one month. DL appears to have no additional positive influence on the peri-implantitis treatment.
- Conditions
- Implant, Peri-Implantitis, Alveolar Bone Loss, Complications
- Being tested
- Conventional peri-implantitis treatment, DL application in peri-implantitis
- Keywords
- dental implant, laser, diode laser, peri-implantitis, bacterial count
- Medical subject headings
- Peri-Implantitis, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional peri-implantitis treatmentProcedure or surgery
Also called CIST treatment protocol
Elimination of the bacterial plaque. Establishing optimal healing conditions. Detoxification of the affected environment.
DL application in peri-implantitisDevice
Diode laser application in the diseased implants.
| Study group | Role | What they receive |
|---|---|---|
| Conventional peri-implantitis treatment | Active comparator | Peri-implantitis treatment according to the Cumulative interceptive supportive (CIST) therapy. Receives: Procedure: Conventional peri-implantitis treatment |
| DL application in peri-implantitis | Experimental | Adjunct Diode Laser application. Receives: Device: DL application in peri-implantitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial counts
Bacterial load around the the diseased implants will be determined at the initiation of the study. The assessment will be performed after one months
Measured: One month
Secondary outcomes (1)
Marginal Bone loss
The marginal bone loss around the diseased implants will be assessed after six months to analyse any bone level change.
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 posted13 Feb 2015 (estimated)
- Study startFeb 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImplantStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Volkan Arisan, Istanbul University
- Investigators
- Volkan Arısan, Ass.Prof.Dr., Study chair, Istanbul University, Faculty of DentistryCuneyt Karabuda, Prof.Dr., Study director, Istanbul University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362854
- Sponsor's protocol ID
- IstanbulU
- Status last verified
- Feb 2015
- First submitted
- 16 Sep 2014
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of an Adjunct Diode Laser Application in the Treatment of Peri-implantitis.
- ClinicalTrials.gov ID
- NCT02362854
- Acronym / sponsor ID
- IstanbulU
- Conditions
- Implant, Peri-Implantitis, Alveolar Bone Loss, Complications
- Keywords
- dental implant, laser, diode laser, peri-implantitis, bacterial count
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- Feb 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 Feb 2015 (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 aim of this study was to compare the efficacy of a diode laser (DL) as an adjunct to conventional scaling in the treatment of mild-to-moderate peri-implantitis. A prospective clinical, radiographic and microbiologic split-mouth study was conducted to test the following null hypothesis; adjunct application of a diode laser, in the conventional treatment of peri-implantitis, are not associated with a statistically significant difference regarding the microbial counts, marginal bone loss and peri-implant parameters.
Detailed description
Efficacy of a diode laser (DL) in peri-implantitis was investigated. 48 implants diagnosed with peri-implantitis were included. In addition to the conventional scaling and debridement, random 24 implants were lased by a DL. Periodontal indexes, microbiologic specimens and radiographs were used for assessment. Baseline parameters were similar between groups. After six months laser group revealed higher MBL than the control group. Microbiota of the implants were found unchanged after one month. DL appears to have no additional positive influence on the peri-implantitis treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional peri-implantitis treatment | Active comparator | Procedure: Conventional peri-implantitis treatmentPeri-implantitis treatment according to the Cumulative interceptive supportive (CIST) therapy. |
| DL application in peri-implantitis | Experimental | Device: DL application in peri-implantitisAdjunct Diode Laser application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older
- No local and systemic health problems prohibit the study interventions
- Bi-lateral implants with peri-implantitis diagnosis
Key exclusion criteria (1 listed)
- Local and systemic health problems prohibiting the study interventions
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 |
|---|---|---|
| Conventional peri-implantitis treatmentAlso: CIST treatment protocolElimination of the bacterial plaque. Establishing optimal healing conditions. Detoxification of the affected environment. | Procedure or surgery | Conventional peri-implantitis treatment |
| DL application in peri-implantitisDiode laser application in the diseased implants. | Device | DL application in peri-implantitis |
Primary outcome
Bacterial counts
Time frame: One month
Bacterial load around the the diseased implants will be determined at the initiation of the study. The assessment will be performed after one months
1 secondary outcome
Marginal Bone loss
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 13 Feb 2015.
- Department web linkLink provided by the sponsor.
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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.
Volkan Arısan, Ass.Prof.Dr. study chair
Istanbul University, Faculty of Dentistry
Cuneyt Karabuda, Prof.Dr. study director
Istanbul University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional peri-implantitis treatment and DL application in peri-implantitis in people with Implant and Peri-Implantitis, run by Istanbul University at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 13 Feb 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 Turkey (Türkiye). 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?
Bacterial counts (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 13 Feb 2015.