Peri-ImplantitisNCT05201443
Clinical and Biochemical Evaluation of the Efficacy of Non-Surgical Treatment Approaches in the Treatment of Peri-implantitis
A study testing Diode laser and Titanium curettes in people with Peri-Implantitis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Peri-implantitis is a pathological condition associated with plaque that develops around dental implants, characterized by inflammation and progressive bone loss in the peri-implant area. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Diode laser and Titanium curettes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Nov 2018to Oct 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence of 5mm or more peri-implant pockets
- Not having periodontal treatment in the last 3 months,
- The informed consent form must be approved,
- At least 18 years old.
Who cannot join
- Presence of systemic disease,
- Smoking,
- Regular use of non-steroidal anti inflammatory drugs,
- Having been treated with antibiotics in the last 3 months,
- Individuals in need of pre-treatment antibiotic prophylaxis,
- Pregnancy and lactation,
- Not approving the informed consent form,
- Patients with known allergies.
Trial locations and contacts
1 site in 1 country.
Güliz Nigar Güncü contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara
Nazan Ece Erduran
About this study
Peri-implantitis is a pathological condition associated with plaque that develops around dental implants, characterized by inflammation and progressive bone loss in the peri-implant area. Bleeding on probing, suppuration, increased pathological pocket depths and/or mucosal recessions are seen with radiographic bone loss in peri-implantitis. When evaluated histologically, the lesion extends to the apical part of the pocket epithelium and contains a large amount of plasma cells, macrophages and neutrophils. In the Peri-implant crevicular fluid analysis, which is one of the most important parameters that enable the biochemical and immunological evaluation of the inflammatory state in the peri-implant region, information about the current inflammatory situation can be obtained by evaluating the content of an osmotic inflammatory exudate originating from the vessels in the gingival plexus. Many surgical and non-surgical methods have been proposed for the treatment of peri-implantitis. Mechanical surface debridement, laser application and air abrasives are a part of non-surgical treatment of peri-implantitis. In this study, we examined the effectiveness of diode laser in addition to mechanical debridement with titanium curettes. In our study, we aimed to compare these two treatments biochemically by determining the changes in interleukin-1β, Interleukin-10, Interleukin-17, RANKL, osteoprotegerin, TWEAK and sclerostin biomarkers in Peri-implant crevicular fluid and clinically.
Read the detailed description
Primary outcome measures (probing depth as clinical parameter) and secondary outcome measures ( collection of gingival crevicular fluid, gingival bleeding time index, gingival index, plaque index and clinical attachment level) asre recorded in baseline, third and sixth month. The change between these parameters is observed.
- Conditions
- Peri-Implantitis
- Being tested
- Diode laser, Titanium curettes
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode laserDevice
Diode Laser is applied to one group as an adjunctive therapy.
Titanium curettesDevice
Non-surgical treatment with titanium curettes were administrated to both groups.
| Study group | Role | What they receive |
|---|---|---|
| Diode Laser | Experimental | At baseline, diode laser is applied to one group. Receives: Device: Diode laser; Device: Titanium curettes |
| Titanium curettes | Active comparator | At baseline, titanium curettes are used to both of the groups Receives: Device: Titanium curettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical parameter probing depth
The primary outcome of the study was the control examination performed 3 months after the first examination. Probing depth was measured with a periodontal probe by the distance between gingival margin and the base of the pocket. The change between these time frames are recorded.
Measured: Baseline, 3 months and 6 months
Secondary outcomes (5)
Another outcome of the study is the collection of gingival crevicular fluid samples in the 3rd month.
Samples are obtained by means of paper strips placed gently in the gingival groove. These samples are stored at -20 ° C for later analysis by ELISA method. The change between these time frames are recorded.
Measured: Baseline, 3 months and 6 months
Gingival bleeding time index
Bleeding on probing according to the time is recorded. The change between these time frames are recorded.
Measured: Baseline, 3 months and 6 months
Gingival index
The gingival index is graded as follows:
0 = Normal gingiva
- Mild inflammation, slight change in color, slight oedema. No bleeding on probing
- Moderate inflammation redness, oedema and glazing. Bleeding on probing
- Severe inflammation marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.
Measured: Baseline, 3 months and 6 months
Plaque index
0 = No plaque in the gingival area.
- A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
- Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
- Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
Measured: Baseline, 3 months and 6 months
Clinical attachment level
The distance in millimeters from the cemento-enamel junction to the bottom of the pocket.
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start12 Nov 2018
- Primary completionApr 2022 (estimated)
- Study completionOct 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.
- More trials run by Hacettepe 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
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazan Ece Erduran, Hacettepe University
- Investigators
- Güliz Nigar GÜNCÜ, Prof. Dr., Study director, study directorAbdullah Cevdet AKMAN, Prof Dr, Principal investigator, Principal InvestigatorRahime Meral NOHUTCU, Principal investigator, Principal InvestigatorAli Tuğrul GÜR, Phd, Principal investigator, Principal InvestigatorAslı PINAR, Prof Dr, Principal investigator, biochemistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201443
- Sponsor's protocol ID
- KA-19059
- Status last verified
- Feb 2022
- First submitted
- 12 Oct 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biochemical Evaluation of the Efficacy of Non-Surgical Treatment Approaches in the Treatment of Peri-implantitis
- ClinicalTrials.gov ID
- NCT05201443
- Acronym / sponsor ID
- KA-19059
- Conditions
- Peri-Implantitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 21 Jan 2022 (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.
Peri-implantitis is a pathological condition associated with plaque that develops around dental implants, characterized by inflammation and progressive bone loss in the peri-implant area. Bleeding on probing, suppuration, increased pathological pocket depths and/or mucosal recessions are seen with radiographic bone loss in peri-implantitis. When evaluated histologically, the lesion extends to the apical part of the pocket epithelium and contains a large amount of plasma cells, macrophages and neutrophils. In the Peri-implant crevicular fluid analysis, which is one of the most important parameters that enable the biochemical and immunological evaluation of the inflammatory state in the peri-implant region, information about the current inflammatory situation can be obtained by evaluating the content of an osmotic inflammatory exudate originating from the vessels in the gingival plexus. Many surgical and non-surgical methods have been proposed for the treatment of peri-implantitis. Mechanical surface debridement, laser application and air abrasives are a part of non-surgical treatment of peri-implantitis. In this study, we examined the effectiveness of diode laser in addition to mechanical debridement with titanium curettes. In our study, we aimed to compare these two treatments biochemically by determining the changes in interleukin-1β, Interleukin-10, Interleukin-17, RANKL, osteoprotegerin, TWEAK and sclerostin biomarkers in Peri-implant crevicular fluid and clinically.
Detailed description
Primary outcome measures (probing depth as clinical parameter) and secondary outcome measures ( collection of gingival crevicular fluid, gingival bleeding time index, gingival index, plaque index and clinical attachment level) asre recorded in baseline, third and sixth month. The change between these parameters is observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diode Laser | Experimental | Device: Diode laser, Device: Titanium curettesAt baseline, diode laser is applied to one group. |
| Titanium curettes | Active comparator | Device: Titanium curettesAt baseline, titanium curettes are used to both of the groups |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of 5mm or more peri-implant pockets
- Not having periodontal treatment in the last 3 months,
- The informed consent form must be approved,
- At least 18 years old.
Key exclusion criteria (8 listed)
- Presence of systemic disease,
- Smoking,
- Regular use of non-steroidal anti inflammatory drugs,
- Having been treated with antibiotics in the last 3 months,
- Individuals in need of pre-treatment antibiotic prophylaxis,
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 |
|---|---|---|
| Diode laserDiode Laser is applied to one group as an adjunctive therapy. | Device | Diode Laser |
| Titanium curettesNon-surgical treatment with titanium curettes were administrated to both groups. | Device | Diode Laser, Titanium curettes |
Primary outcome
Clinical parameter probing depth
Time frame: Baseline, 3 months and 6 months
The primary outcome of the study was the control examination performed 3 months after the first examination. Probing depth was measured with a periodontal probe by the distance between gingival margin and the base of the pocket. The change between these time frames are recorded.
5 secondary outcomes
Another outcome of the study is the collection of gingival crevicular fluid samples in the 3rd month.
Time frame: Baseline, 3 months and 6 months
Gingival bleeding time index
Time frame: Baseline, 3 months and 6 months
Gingival index
Time frame: Baseline, 3 months and 6 months
Plaque index
Time frame: Baseline, 3 months and 6 months
Clinical attachment level
Time frame: Baseline, 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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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.
Güliz Nigar Güncü contact
Güliz Nigar GÜNCÜ, Prof. Dr. study director
study director
Abdullah Cevdet AKMAN, Prof Dr principal investigator
Principal Investigator
Rahime Meral NOHUTCU principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diode laser and Titanium curettes in people with Peri-Implantitis, run by Hacettepe 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 4 inclusion and 8 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 2 Mar 2022. 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 Nazan Ece ERDURAN (00905541900462, nazaneceerduran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical parameter probing depth (time frame: Baseline, 3 months and 6 months). 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 2 Mar 2022.