Periodontal InflammationNCT04253613
Laser Biostimulation in Periodontal Treatment
An observational study of Periodontal Inflammation and Periodontal Diseases, run by Ondokuz Mayıs University.
Trial summary
The use of nonsurgical periodontal treatment, together with plaque control is considered the gold standart for the treatment of periodontal diseases; it produces beneficial effects such as reductions in clinical inflammation, decreases in pocket depth and increases in clinical attachment levels .However to modulate… Read more about this study
- Who is it for?
- Ages 35 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Periodontal Inflammation, Periodontal Diseases
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2013to 15 Jun 2014
- Phase
- Observational
- 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 35 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study was designed as a split-mouth, controlled, double-blind clinical study. Participants were recruited among patients admitted to the periodontology clinic in Ondokuz Mayıs university Dental Faculty. Periodontal status was assessed and diagnosed as generalized periodontitis. In the mouth of each patient in both diabetic and healthy population, two symmetrical teeth were assigned as one side to apply non-surgical periodontal treatment alone and the other side to apply laser biostimulation therapy adjunct to NSPT. Thus,15 diabetic and 15 systemically helathy subjects included in the split-mouth designed study and 4 groups were constituted as:periodontal therapy (n=15, Split-mouth); periodontal+laser therapy (n=15, Split-mouth); diabetic periodontal therapy (n=15, Split-mouth); diabetic periodontal+laser therapy(n=15, Split-mouth):
Who may be able to join
- Volunteering to participate in the study, being male and ≥ 35 years of age,
- Having been diagnosed as type 2 diabates mellitus (DM2) with the ADA criteria at least 2 years before the study and having an HbA1c value of ≥ 7 for DM2 group,
- Not having a systemic disease other than DM2 for diabetic group; and not having any systemical diseases for systemically healthy group,
- Not having any systemic complications of diabetes,
- Not smoking or consuming alcohol,
- Having at least 20 teeth,
- Having at least two single-rooted teeth (like one premolar or incisor tooth) representing symmetrical or same group teeth with gingival index≥2, bleeding on probing (+), probing pocket depth and/or clinical attachment lvel >5 mm as well as ≥30% radiographically observable alveolar bone loss, on the left and right area of mandibular,
- Being able to fulfill the instructions for oral hygiene training
Who cannot join
- using systemic antimicrobials, non-steroidal anti-inflammatory drugs and/or steroids during the 6 weeks prior to data collection
- received periodontal treatment in the 6 months prior to data collection
- having predisposing factors such as a dental crown, bridge, filling, or cavity on teeth from which the GCF was to be collected.
About this study
Official title: Laser Biostimulation in Periodontal Treatment of Diabetic and Systemically Healthy Periodontitis Patients
The use of nonsurgical periodontal treatment, together with plaque control is considered the gold standart for the treatment of periodontal diseases; it produces beneficial effects such as reductions in clinical inflammation, decreases in pocket depth and increases in clinical attachment levels .However to modulate the healing response additional protocols has been suggested to increase the efficacy of existing treatment protocols. Laser biostimulation therapy is highly preferred method used due to its healing acceleration effect on several wounds in medical field. Thus,the investigators aimed to evaluate the laser biostimulation therapy adjunct to non-surgical periodontal treatment in systemically healthy and uncontrolled type 2 diabetes mellitus patients with generalized periodontitis. The effects of laser irradiation with Nd-YAG laser at the 1064-nm wavelength as an adjunct to non-surgical periodontal treatment (NSPT) was analysed by means of IL-1β and IL-10 concentrations in gingival crevicular fluid and periodontal clinical measurements of systemically healthy and uncontroled DM2 patients with generalized periodontitis.
Read the detailed description
Today, the one that stands out the most among these protocols is laser application which was concluded to be a support or be an alternative treatment approach to standart periodontal treatments . As the laser biostimulation therapy(LBT) has been investigated by means of anti-inflammatory and healing promotion action on periodontal tissues, the LBT adjunct to non-surgical periodontal treatment of diabetic patients expected to create positive healing effects. The biostimulation effect of laser on tissue healing has drawn significant attention, not only in healthy individuals but also in patients with systemic problems causing impaired wound healing such as diabetes mellitus . Patients with poor metabolic control frequently present impaired wound healing and using LBT as a treatment method for diabetic ulcers have shown positive healing effects . However, there has been little knowledge about the additional benefits of LBT on healing proccess or inflammatory response among patients with uncontrolled diabetes mellitus type 2 receiving periodontal treatment.
In the light of the current knowledge, the impaired wound healing seen in diabetic patients may be a reason to require an additional approach in periodontal treatment like biostimulation of periodontal tissues by several ways. In order to determine the healing response, the investigators aimed to evaluate the effects of LBT irradiation with Nd-YAG laser at the 1064-nm wavelength as an adjunct to non-surgical periodontal treatment (NSPT) by means of periodontal clinical measurements and gingival crevicular fluid cytokine levels (IL-1β and IL-10) in systemically healthy and uncontroled DM2 patients with generalized periodontitis .
The study was designed as a split-mouth randomized, controlled, double-blind clinical study. The study protocol was approved by the Local Ethics Committee of Ondokuz Mayıs University and Turkey Ministry of Health, Drug and Medical Device Agency . The written informed consent was obtained from all study participants in accordance with the Helsinki Declaration .
All participants with periodontitis received NSPT. Non-surgical periodontal treatment consisted of conventional quadrant scaling in four session of 30 min, each on a weekly basis, using scalers, curettes and ultrasonic devices.
Laser Biostimulation treatment (LBT) and Sham application: Following NSPT, either the left or right side of each periodontitis patient was randomly selected (by coin toss) to receive LBT or sham treatment. LBT was performed six times (on the same day 30 which was the last scalling and root planning session and repeated weekly for 5 more times) using a 1064 nm Nd.YAG laser (Fotona AT Fidelis III,Ljubljana, Slovenia).
Clinical Measurements and Gingival creviculat fluid (GCF) Sampling Clinical measurements were performed before NSPT (baseline) and on days 30, 37 and 72 of the follow-up for both DM2 and SH groups. The following clinical periodontal measurements were recorded Silness \& Löe plaque index (PI), Löe \& Silness gingival index(GI), probing pocket depth (PPD); clinical attachment level (CAL); bleeding on probing (BOP). A Williams periodontal probe (Nordent Manufacturing Inc., Elk Grove Village, IL, USA) calibrated in mm was used to measure 6 sites on each selected tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations). For each tooth, the side with the highest PPD and CAL values were identified, and the additional clinical measurements and GCF sampling were performed on this side in both LBT and sham application of the patients. (total: 30 teeth in DM2 group, 30 teeth in SH group). GCF samples were collected before NSPT treatment(baseline) and on Days 30, 37 and 72 of follow-up. Sampling sites were isolated with cotton rolls, saliva was removed, and supragingival plaque, if present, was removed using a sterile curette. GCF was sampled by placing a strip of filter paper (Periopaper, ProFlow, Inc., Amityville, New York, USA) into the crevice until mild resistance was felt and then leaving it in position for 30 seconds. The GCF volume of each strip was determined by electronic impedance (Periotron 8000, ProFlow, Inc.), and samples were then placed in sterile polypropylene tubes and stored at -70°C until analysis.
Amounts of IL-1β and IL-10 in each GCF sample were evaluated using standard enzyme-linked immunosorbent assays (ELISA) according to the manufacturers' instructions.
- Conditions
- Periodontal Inflammation, Periodontal Diseases
- Keywords
- periodontitis, diabetes mellitus, periodontal treatment, laser biostimulation therapy
- Medical subject headings
- Periodontal Diseases, Periodontitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| periodontal therapy | Systemically healthy subjects with periodontitis that have the sides treated with non-surgical periodontal treatment (NSPT) split-mouth designed study | |
| periodontal+laser therapy | Systemically healthy subjects with periodontitis that have the contra-lateral sides treated with laser biostimulation therapy(LBT) adjunct to non-surgical periodontal treatment(NSPT) split-mouth designed study | |
| diabetic periodontal therapy | Type 2 diabetic(DM2) subjects with periodontitis that have the sides treated with non-surgical periodontal treatment (NSPT) split-mouth designed study | |
| diabetic periodontal+laser therapy | Type 2 diabetic(DM2) subjects with periodontitis that have the contra-lateral sides treated with laser biostimulation therapy(LBT) adjunct to non-surgical periodontal treatment (NSPT) split-mouth designed study |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-1β level in GCF
IL-1β is a cytokine present in gingival crevicular fluid (GCF). Its concentration is calculated as picogram/microliter and it changes due to the elimination of inflammation by periodontal therapy.
Measured: GCF sampling was performed prior to periodontal treatment and on days 30,37,72 of follow-up.
IL-10 level in GCF
IL-10 is a cytokine present in gingival crevicular fluid (GCF). Its concentration is calculated as picogram/microliter and it changes due to the elimination of inflammation by periodontal therapy.
Measured: GCF sampling was performed prior to periodontal treatment and on days 30,37,72 of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start15 Jan 2013
- Primary completion15 Jun 2014
- Study completion15 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal InflammationStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, muge lutfioglu, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253613
- Sponsor's protocol ID
- OMU KAEK2012/49
- Status last verified
- Jan 2020
- First submitted
- 31 Jan 2020
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Biostimulation in Periodontal Treatment of Diabetic and Systemically Healthy Periodontitis Patients
- ClinicalTrials.gov ID
- NCT04253613
- Acronym / sponsor ID
- OMU KAEK2012/49
- Conditions
- Periodontal Inflammation, Periodontal Diseases
- Keywords
- periodontitis, diabetes mellitus, periodontal treatment, laser biostimulation therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 15 Jan 2013 (actual)
- Primary completion
- 15 Jun 2014 (actual)
- Study completion
- 15 Jun 2014 (actual)
- First posted
- 5 Feb 2020 (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.
The use of nonsurgical periodontal treatment, together with plaque control is considered the gold standart for the treatment of periodontal diseases; it produces beneficial effects such as reductions in clinical inflammation, decreases in pocket depth and increases in clinical attachment levels .However to modulate the healing response additional protocols has been suggested to increase the efficacy of existing treatment protocols. Laser biostimulation therapy is highly preferred method used due to its healing acceleration effect on several wounds in medical field. Thus,the investigators aimed to evaluate the laser biostimulation therapy adjunct to non-surgical periodontal treatment in systemically healthy and uncontrolled type 2 diabetes mellitus patients with generalized periodontitis. The effects of laser irradiation with Nd-YAG laser at the 1064-nm wavelength as an adjunct to non-surgical periodontal treatment (NSPT) was analysed by means of IL-1β and IL-10 concentrations in gingival crevicular fluid and periodontal clinical measurements of systemically healthy and uncontroled DM2 patients with generalized periodontitis.
Detailed description
Today, the one that stands out the most among these protocols is laser application which was concluded to be a support or be an alternative treatment approach to standart periodontal treatments . As the laser biostimulation therapy(LBT) has been investigated by means of anti-inflammatory and healing promotion action on periodontal tissues, the LBT adjunct to non-surgical periodontal treatment of diabetic patients expected to create positive healing effects. The biostimulation effect of laser on tissue healing has drawn significant attention, not only in healthy individuals but also in patients with systemic problems causing impaired wound healing such as diabetes mellitus . Patients with poor metabolic control frequently present impaired wound healing and using LBT as a treatment method for diabetic ulcers have shown positive healing effects . However, there has been little knowledge about the additional benefits of LBT on healing proccess or inflammatory response among patients with uncontrolled diabetes mellitus type 2 receiving periodontal treatment.
In the light of the current knowledge, the impaired wound healing seen in diabetic patients may be a reason to require an additional approach in periodontal treatment like biostimulation of periodontal tissues by several ways. In order to determine the healing response, the investigators aimed to evaluate the effects of LBT irradiation with Nd-YAG laser at the 1064-nm wavelength as an adjunct to non-surgical periodontal treatment (NSPT) by means of periodontal clinical measurements and gingival crevicular fluid cytokine levels (IL-1β and IL-10) in systemically healthy and uncontroled DM2 patients with generalized periodontitis .
The study was designed as a split-mouth randomized, controlled, double-blind clinical study. The study protocol was approved by the Local Ethics Committee of Ondokuz Mayıs University and Turkey Ministry of Health, Drug and Medical Device Agency . The written informed consent was obtained from all study participants in accordance with the Helsinki Declaration .
All participants with periodontitis received NSPT. Non-surgical periodontal treatment consisted of conventional quadrant scaling in four session of 30 min, each on a weekly basis, using scalers, curettes and ultrasonic devices.
Laser Biostimulation treatment (LBT) and Sham application: Following NSPT, either the left or right side of each periodontitis patient was randomly selected (by coin toss) to receive LBT or sham treatment. LBT was performed six times (on the same day 30 which was the last scalling and root planning session and repeated weekly for 5 more times) using a 1064 nm Nd.YAG laser (Fotona AT Fidelis III,Ljubljana, Slovenia).
Clinical Measurements and Gingival creviculat fluid (GCF) Sampling Clinical measurements were performed before NSPT (baseline) and on days 30, 37 and 72 of the follow-up for both DM2 and SH groups. The following clinical periodontal measurements were recorded Silness \& Löe plaque index (PI), Löe \& Silness gingival index(GI), probing pocket depth (PPD); clinical attachment level (CAL); bleeding on probing (BOP). A Williams periodontal probe (Nordent Manufacturing Inc., Elk Grove Village, IL, USA) calibrated in mm was used to measure 6 sites on each selected tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations). For each tooth, the side with the highest PPD and CAL values were identified, and the additional clinical measurements and GCF sampling were performed on this side in both LBT and sham application of the patients. (total: 30 teeth in DM2 group, 30 teeth in SH group). GCF samples were collected before NSPT treatment(baseline) and on Days 30, 37 and 72 of follow-up. Sampling sites were isolated with cotton rolls, saliva was removed, and supragingival plaque, if present, was removed using a sterile curette. GCF was sampled by placing a strip of filter paper (Periopaper, ProFlow, Inc., Amityville, New York, USA) into the crevice until mild resistance was felt and then leaving it in position for 30 seconds. The GCF volume of each strip was determined by electronic impedance (Periotron 8000, ProFlow, Inc.), and samples were then placed in sterile polypropylene tubes and stored at -70°C until analysis.
Amounts of IL-1β and IL-10 in each GCF sample were evaluated using standard enzyme-linked immunosorbent assays (ELISA) according to the manufacturers' instructions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| periodontal therapy | – | –Systemically healthy subjects with periodontitis that have the sides treated with non-surgical periodontal treatment (NSPT) split-mouth designed study |
| periodontal+laser therapy | – | –Systemically healthy subjects with periodontitis that have the contra-lateral sides treated with laser biostimulation therapy(LBT) adjunct to non-surgical periodontal treatment(NSPT) split-mouth designed study |
| diabetic periodontal therapy | – | –Type 2 diabetic(DM2) subjects with periodontitis that have the sides treated with non-surgical periodontal treatment (NSPT) split-mouth designed study |
| diabetic periodontal+laser therapy | – | –Type 2 diabetic(DM2) subjects with periodontitis that have the contra-lateral sides treated with laser biostimulation therapy(LBT) adjunct to non-surgical periodontal treatment (NSPT) split-mouth designed study |
Who may qualify
- Ages
- 35 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study was designed as a split-mouth, controlled, double-blind clinical study. Participants were recruited among patients admitted to the periodontology clinic in Ondokuz Mayıs university Dental Faculty. Periodontal status was assessed and diagnosed as generalized periodontitis. In the mouth of each patient in both diabetic and healthy population, two symmetrical teeth were assigned as one side to apply non-surgical periodontal treatment alone and the other side to apply laser biostimulation therapy adjunct to NSPT. Thus,15 diabetic and 15 systemically helathy subjects included in the split-mouth designed study and 4 groups were constituted as:periodontal therapy (n=15, Split-mouth); periodontal+laser therapy (n=15, Split-mouth); diabetic periodontal therapy (n=15, Split-mouth); diabetic periodontal+laser therapy(n=15, Split-mouth):
Key inclusion criteria (8 listed)
- Volunteering to participate in the study, being male and ≥ 35 years of age,
- Having been diagnosed as type 2 diabates mellitus (DM2) with the ADA criteria at least 2 years before the study and having an HbA1c value of ≥ 7 for DM2 group,
- Not having a systemic disease other than DM2 for diabetic group; and not having any systemical diseases for systemically healthy group,
- Not having any systemic complications of diabetes,
- Not smoking or consuming alcohol,
Key exclusion criteria (3 listed)
- using systemic antimicrobials, non-steroidal anti-inflammatory drugs and/or steroids during the 6 weeks prior to data collection
- received periodontal treatment in the 6 months prior to data collection
- having predisposing factors such as a dental crown, bridge, filling, or cavity on teeth from which the GCF was to be collected.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IL-1β level in GCF
Time frame: GCF sampling was performed prior to periodontal treatment and on days 30,37,72 of follow-up.
IL-1β is a cytokine present in gingival crevicular fluid (GCF). Its concentration is calculated as picogram/microliter and it changes due to the elimination of inflammation by periodontal therapy.
IL-10 level in GCF
Time frame: GCF sampling was performed prior to periodontal treatment and on days 30,37,72 of follow-up.
IL-10 is a cytokine present in gingival crevicular fluid (GCF). Its concentration is calculated as picogram/microliter and it changes due to the elimination of inflammation by periodontal therapy.
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 6 Jul 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Inflammation and Periodontal Diseases, run by Ondokuz Mayıs University.
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 8 inclusion and 3 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 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
IL-1β level in GCF (time frame: GCF sampling was performed prior to periodontal treatment and on days 30,37,72 of follow-up.). The study lists 2 primary outcomes in all. 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 6 Jul 2022.