PeriodontitisNCT04908098
Diode Laser Application With Non-Surgical Periodontal Treatment
A study testing diode laser and scaling - root planning in people with Periodontitis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Periodontitis is an infectious disease that causes destruction of periodontal tissues with complex etiology that develops due to local and systemic factors. Host-derived enzymes, cytokines and proinflammatory markers are the main elements that play a role in this degradation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- diode laser and scaling - root planning
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2019to 10 Aug 2021
- 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 periodontal pockets on one or more surfaces in periodontal tissues,
- 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.
About this study
Official title: Clinical and Biochemical Evaluation of the Effectiveness of Diode Laser Application With Non-Surgical Periodontal Treatment
Periodontitis is an infectious disease that causes destruction of periodontal tissues with complex etiology that develops due to local and systemic factors. Host-derived enzymes, cytokines and proinflammatory markers are the main elements that play a role in this degradation. New techniques such as non-surgical or surgical methods combined with laser application are used for its treatment.
The subjects were divided into two groups as "Individuals Applied with Diode Laser in Addition to Non-Surgical Periodontal Treatment" (Laser group) and "Individuals with Non-Surgical Periodontal Treatment (SRP)" (Control group). While only non-surgical periodontal treatment was applied to individuals in the control group; In the laser group, diode laser was applied in addition to this treatment. All individuals were examined 1 and 3 months after treatment.The scaling root planing (SRP) procedure was performed mechanically with gracey curettes under local anesthesia. The diode laser applied to the study group was applied parallel to the gingival sulcus at 0.80W power, 940 nm wavelength and 0.80 J / s energy level in continuous phase. Gingival crevicular fluid (GCF) samples were taken without any procedure in order not to change the amount and content. All clinical parameters were also measured by the same investigator before SRP and in all participants. After this treatment, the participants were re-examined in the 1st and 3rd months for control purposes and GCF samples were taken from the same regions again and the clinical parameters were measured again by the same researcher. GCF samples were stored at -20 degrees Celsius until ELISA studies were performed. Clinical parameters (pocket depth, clinical attachment loss, bleeding on probing, gingival index, plaque index) and gingival crevicular fluid (GCF) sampling were obtained at each control. IL-1β, IL-10, IL-17, OPG, RANKL, TWEAK, Sclerostin levels in GCF samples were measured with ELISA method.
The aim of this study is to evaluate the effectiveness of diode laser application in addition to non-surgical treatment in periodontitis treatment clinically and biochemically and to assess the potential biomarkers for use.
- Conditions
- Periodontitis
- Being tested
- diode laser, scaling - root planning
- Keywords
- periodontitis, Gingival crevicular fluid, diode laser, sclerostin, TWEAK
- Medical subject headings
- Periodontitis, Sclerosteosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diode laserDevice
It is the application of the laser tip parallel to the inner surface of the periodontal pocket
scaling - root planningProcedure or surgery
Scaling is the removal of calculus and other deposits in the root of the tooth.Root planning is the removal of necrotic cementum on the tooth root surface. Scaler and gracey curettes are used for these operations.
| Study group | Role | What they receive |
|---|---|---|
| Laser group | Experimental | Root-planning was performed using Gracey curettes in the areas where periodontal pockets were diagnosed after scaling. Laser application was then applied to the areas where root planning was applied. Laser was applied in continuous phase at 0.80W power, 940 nm wavelength and 0.80 J / s energy level. Receives: Device: diode laser; Procedure: scaling - root planning |
| Control group | Active comparator | Root-planning was performed using Gracey curettes in the areas where periodontal pockets were diagnosed after scaling. Receives: Procedure: scaling - root planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the study was the control examination performed 3 months after the first examination. At the 3rd month control, the same researcher measured clinical parameters from all patients
Probing depth is the measurement from the free gingival margin, to the base of the pocket in millimeters of the distance. Periodontal probe is used.
Measured: 3 months
Secondary outcomes (5)
The secondary outcome of the study is the recording of bleeding index in the 3rd month.
The bleeding index is evaluated as positive if there is bleeding in the gingiva during probing.
Measured: 3 months
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.
Measured: 3 months
The secondary outcome of the study is a measure of the clinical attachment level.
The distance in millimeters from the cemento enamel junction to the bottom of the pocket.
Measured: 3 months
The secondary outcome of the study is the recording of gingival index in the 3rd month.
The gingival index is graded as follows:
0 = Normal gingiva
- = Mild inflammationslight 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: 3 months
The secondary outcome of the study is the recording of plaque index in the 3rd month.
The plaque index is graded as follows:
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: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start10 Nov 2019
- Primary completion10 Aug 2020
- Study completion10 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Model description
- Participants were divided into two groups as study and control.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Tugrul Gur, Hacettepe University
- Investigators
- Ali Tuğrul Gür, Dentist, Principal investigator, Principal InvestigatorGüliz Nigar Güncü, Professor, Study director, study directorAbdullah Cevdet Akman, professor, Principal investigator, Study principal investigatorRahime Meral Nohutcu, professor, Principal investigator, study principal investigatorAslı Pınar, Professor, Principal investigator, biochemistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908098
- Sponsor's protocol ID
- TSA-2019-18111
- Status last verified
- May 2021
- First submitted
- 8 May 2021
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual data of the participants will not be shared. Statistical analysis of the study will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biochemical Evaluation of the Effectiveness of Diode Laser Application With Non-Surgical Periodontal Treatment
- ClinicalTrials.gov ID
- NCT04908098
- Acronym / sponsor ID
- TSA-2019-18111
- Conditions
- Periodontitis
- Keywords
- periodontitis, Gingival crevicular fluid, diode laser, sclerostin, TWEAK
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 10 Nov 2019 (actual)
- Primary completion
- 10 Aug 2020 (actual)
- Study completion
- 10 Aug 2021 (estimated)
- First posted
- 1 Jun 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.
Periodontitis is an infectious disease that causes destruction of periodontal tissues with complex etiology that develops due to local and systemic factors. Host-derived enzymes, cytokines and proinflammatory markers are the main elements that play a role in this degradation. New techniques such as non-surgical or surgical methods combined with laser application are used for its treatment.
The subjects were divided into two groups as "Individuals Applied with Diode Laser in Addition to Non-Surgical Periodontal Treatment" (Laser group) and "Individuals with Non-Surgical Periodontal Treatment (SRP)" (Control group). While only non-surgical periodontal treatment was applied to individuals in the control group; In the laser group, diode laser was applied in addition to this treatment. All individuals were examined 1 and 3 months after treatment.The scaling root planing (SRP) procedure was performed mechanically with gracey curettes under local anesthesia. The diode laser applied to the study group was applied parallel to the gingival sulcus at 0.80W power, 940 nm wavelength and 0.80 J / s energy level in continuous phase. Gingival crevicular fluid (GCF) samples were taken without any procedure in order not to change the amount and content. All clinical parameters were also measured by the same investigator before SRP and in all participants. After this treatment, the participants were re-examined in the 1st and 3rd months for control purposes and GCF samples were taken from the same regions again and the clinical parameters were measured again by the same researcher. GCF samples were stored at -20 degrees Celsius until ELISA studies were performed. Clinical parameters (pocket depth, clinical attachment loss, bleeding on probing, gingival index, plaque index) and gingival crevicular fluid (GCF) sampling were obtained at each control. IL-1β, IL-10, IL-17, OPG, RANKL, TWEAK, Sclerostin levels in GCF samples were measured with ELISA method.
The aim of this study is to evaluate the effectiveness of diode laser application in addition to non-surgical treatment in periodontitis treatment clinically and biochemically and to assess the potential biomarkers for use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were divided into two groups as study and control.
| Arm | Type | Receives |
|---|---|---|
| Laser group | Experimental | Device: diode laser, Procedure: scaling - root planningRoot-planning was performed using Gracey curettes in the areas where periodontal pockets were diagnosed after scaling. Laser application was then applied to the areas where root planning was applied. Laser was applied in continuous phase at 0.80W power, 940 nm wavelength and 0.80 J / s energy level. |
| Control group | Active comparator | Procedure: scaling - root planningRoot-planning was performed using Gracey curettes in the areas where periodontal pockets were diagnosed after scaling. |
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 periodontal pockets on one or more surfaces in periodontal tissues,
- 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 laserIt is the application of the laser tip parallel to the inner surface of the periodontal pocket | Device | Laser group |
| scaling - root planningScaling is the removal of calculus and other deposits in the root of the tooth.Root planning is the removal of necrotic cementum on the tooth root surface. Scaler and gracey curettes are used for these operations. | Procedure or surgery | Control group, Laser group |
Primary outcome
The primary outcome of the study was the control examination performed 3 months after the first examination. At the 3rd month control, the same researcher measured clinical parameters from all patients
Time frame: 3 months
Probing depth is the measurement from the free gingival margin, to the base of the pocket in millimeters of the distance. Periodontal probe is used.
5 secondary outcomes
The secondary outcome of the study is the recording of bleeding index in the 3rd month.
Time frame: 3 months
Another outcome of the study is the collection of gingival crevicular fluid samples in the 3rd month.
Time frame: 3 months
The secondary outcome of the study is a measure of the clinical attachment level.
Time frame: 3 months
The secondary outcome of the study is the recording of gingival index in the 3rd month.
Time frame: 3 months
The secondary outcome of the study is the recording of plaque index in the 3rd month.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Individual participant dataSharing planned: No. The individual data of the participants will not be shared. Statistical analysis of the study will be shared.
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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.
Ali Tuğrul Gür, Dentist principal investigator
Principal Investigator
Güliz Nigar Güncü, Professor study director
study director
Abdullah Cevdet Akman, professor principal investigator
Study 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 scaling - root planning in people with Periodontitis, 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 1 Jun 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?
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?
The primary outcome of the study was the control examination performed 3 months after the first examination. At the 3rd month control, the same researcher measured clinical parameters from all patients (time frame: 3 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 1 Jun 2021.