Peri-ImplantitisNCT04826783
Use of Various Laser Systems in Peri-implatit
A study testing Lasers in people with Peri-Implantitis, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
Objectives: In recent years, a new field of work has been created with the use of laser beam to provide titanium surface decontamination. The aim of this study was to evaluate the effect of various laser systems in smokers and non-smokers with peri-implantitis. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Lasers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2021to 25 Apr 2022
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of pocket in probing depth of ≥4 mm in at least one implant
- No mobility in implant
- Implants with bridge foot and opposite occlusion
- Having no systemic disease that may affect the outcome of treatment
- No systemic use of antibiotics for the last six months
- Not receiving peri-implantitis treatment for the last three months
- Individuals at the 30-60 years of age.
Who cannot join
- Individuals who did not agree to participate in the study
- Individuals receiving radiation therapy
- Individuals using alcohol
- Presence of pregnancy and lactation period
- Individuals with parafunctional habits such as clenching or bruxism.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kırıkkale University faculty of Dentistry
Yahşihan, Kırıkkale
kubilay barış, 05539736477, dt.bkubilay@gmail.com
About this study
Official title: Effect of Various Laser Systems in Smokers and Nonsmokers With Peri-implantitis: A Randomized, Prospective, Single-Blind Clinical Trial
Objectives: In recent years, a new field of work has been created with the use of laser beam to provide titanium surface decontamination. The aim of this study was to evaluate the effect of various laser systems in smokers and non-smokers with peri-implantitis.
Materials and Methods: According to the study protocol, patients, who were diagnosed with peri-implantitis based on the clinical and radiographic evaluations, were divided into six groups: Group 1: smokers undergoing diode laser application; Group 2: smokers undergoing Erbium, chromium: yttrium, scandium, gallium, garnet (Er, Cr:YSGG) laser application; Group 3: smokers undergoing Erbium:yttrium-aluminum-garnet (Er:YAG) laser application; Group 4: non-smokers undergoing diode laser application; Group 5: non-smokers undergoing Er, Cr:YSGG laser application; and Group 6: non-smokers undergoing Er:YAG laser application. Peri-implant sulcus depth (SD), clinical attachment level (CAL), suppuration, modified plaque index (mPI), gingival index (GI), and modified sulcus bleeding index (mSBI) were recorded and peri-implant sulcus fluid (PISF) was collected to evaluate osteocalcin.
- Conditions
- Peri-Implantitis
- Being tested
- Lasers
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LasersDevice
The laser tip was applied as vertical and horizontal scan along the subgingival implant . The procedure was carried out on day zero, seven and 14.
| Study group | Role | What they receive |
|---|---|---|
| Diode laser | Experimental | Not described Receives: Device: Lasers |
| Er,Cr:YSGG laser | Experimental | Not described Receives: Device: Lasers |
| Er:YAG LAser | Experimental | Not described Receives: Device: Lasers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sulcus depth
Measured: basaline - six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start25 Apr 2021 (estimated)
- Primary completion25 Oct 2021 (estimated)
- Study completion25 Apr 2022 (estimated)
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.
- 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
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubilay BARIŞ, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826783
- Sponsor's protocol ID
- Interventional
- Status last verified
- Mar 2021
- First submitted
- 23 Jan 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- 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 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Various Laser Systems in Smokers and Nonsmokers With Peri-implantitis: A Randomized, Prospective, Single-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04826783
- Acronym / sponsor ID
- Interventional
- Conditions
- Peri-Implantitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 25 Apr 2021 (estimated)
- Primary completion
- 25 Oct 2021 (estimated)
- Study completion
- 25 Apr 2022 (estimated)
- First posted
- 1 Apr 2021 (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.
Objectives: In recent years, a new field of work has been created with the use of laser beam to provide titanium surface decontamination. The aim of this study was to evaluate the effect of various laser systems in smokers and non-smokers with peri-implantitis.
Materials and Methods: According to the study protocol, patients, who were diagnosed with peri-implantitis based on the clinical and radiographic evaluations, were divided into six groups: Group 1: smokers undergoing diode laser application; Group 2: smokers undergoing Erbium, chromium: yttrium, scandium, gallium, garnet (Er, Cr:YSGG) laser application; Group 3: smokers undergoing Erbium:yttrium-aluminum-garnet (Er:YAG) laser application; Group 4: non-smokers undergoing diode laser application; Group 5: non-smokers undergoing Er, Cr:YSGG laser application; and Group 6: non-smokers undergoing Er:YAG laser application. Peri-implant sulcus depth (SD), clinical attachment level (CAL), suppuration, modified plaque index (mPI), gingival index (GI), and modified sulcus bleeding index (mSBI) were recorded and peri-implant sulcus fluid (PISF) was collected to evaluate osteocalcin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diode laser | Experimental | Device: Lasers |
| Er,Cr:YSGG laser | Experimental | Device: Lasers |
| Er:YAG LAser | Experimental | Device: Lasers |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Presence of pocket in probing depth of ≥4 mm in at least one implant
- No mobility in implant
- Implants with bridge foot and opposite occlusion
- Having no systemic disease that may affect the outcome of treatment
- No systemic use of antibiotics for the last six months
Key exclusion criteria (5 listed)
- Individuals who did not agree to participate in the study
- Individuals receiving radiation therapy
- Individuals using alcohol
- Presence of pregnancy and lactation period
- Individuals with parafunctional habits such as clenching or bruxism.
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 |
|---|---|---|
| LasersThe laser tip was applied as vertical and horizontal scan along the subgingival implant . The procedure was carried out on day zero, seven and 14. | Device | Diode laser, Er,Cr:YSGG laser, Er:YAG LAser |
Primary outcome
Sulcus depth
Time frame: basaline - six month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: Undecided
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ATR-FTIR and Raman Spectroscopy of Peri-Implant Crevicular Fluid in Peri-Implantitis
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lasers in people with Peri-Implantitis, run by Kırıkkale 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact kubilay barış (05539736477, dt.bkubilay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sulcus depth (time frame: basaline - six 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 1 Apr 2021.