Periodontal DiseasesNCT05233501
Low-level Laser Therapy as an Adjunct to Non-surgical Periodontal Treatment
A study testing low level laser therapy and non-surgical periodontal treatment in people with Periodontal Diseases and Periodontal Attachment Loss, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial summary
The present study aimed to investigate the effects of low-level laser therapy (LLLT) as an adjunct to non-surgical periodontal treatment (NSPT) on the plasminogen-activating system in Stage 3-4, Grade C periodontitis patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Periodontal Attachment Loss, Periodontal Disease, AVDC Stage 3
- What is being tested?
- low level laser therapy and non-surgical periodontal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2017to 30 Aug 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Stage 3-4, Grade C periodontitis (at least one site with probing depth (PD) and clinical attachment level (CAL) ≥5 mm in their incisors and/or first molars and at least 6 other teeth with similar PD and CAL measurements, with alveolar bone loss confirmed by radiography; familial aggregation;
- presence of ≥16 teeth;
- no periodontal treatment in the 6 months prior to data collection;
- non-smoker
Who cannot join
- systemic problems, including a medical history of cancer, rheumatoid arthritis, diabetes mellitus, or cardiovascular disease;
- compromised immune system;
- pregnancy, menopause, or lactation;
- ongoing drug therapy that might affect the clinical characteristics of periodontitis;
- use of systemic antimicrobials during the 6 weeks prior to data collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Low-level Laser Therapy on Levels of Tissue Plasminogen Activator and Plasminogen Activator Inhibitor 1 in Gingival Crevicular Fluid of Stage 3-4, Grade C Periodontitis Patients Received Non-surgical Periodontal Treatment.
The present study aimed to investigate the effects of low-level laser therapy (LLLT) as an adjunct to non-surgical periodontal treatment (NSPT) on the plasminogen-activating system in Stage 3-4, Grade C periodontitis patients.
Read the detailed description
Limited data is available regarding the effects of various periodontal treatment protocols on GCF t-PA and PAI-1 levels, and the extent to which LLLT in conjunction with NSPT affects these levels in patients with Stage 3-4, Grade C periodontitis is unknown. Therefore, this study measured standard clinical outcomes and GCF t-PA and PAI-1 levels in patients with Stage 3-4 Grade, C periodontitis in order to assess the use of LLLT as an adjunct to standard NSPT.
This split-mouth study was conducted with 15 Stage 3-4, Grade C periodontitis patients and 15 healthy individuals matched for age and sex. Participants were grouped as follows: Periodontitis/NSPT (Sham); Periodontitis/NSPT+LLLT (LLLT); Periodontally Healthy (Control). LLLT was applied following NSPT and again on post-treatment Days 2 and 7. Clinical parameters were recorded at baseline (i.e. before NSPT) and on Day 30. Gingival crevicular fluid (GCF) samples were collected at baseline and during follow-up visits on Days 7, 14 and 30. GCF t-PA and PAI-1 levels were measured with ELISA.
- Conditions
- Periodontal Diseases, Periodontal Attachment Loss, Periodontal Disease, AVDC Stage 3, Periodontal Inflammation, Periodontal Disease, AVDC Stage 4
- Being tested
- low level laser therapy, non-surgical periodontal treatment
- Keywords
- periodontitis, lasers, prospective, plasminogen activator inhibitor 1, tissue plasminogen activator, low-level laser therapy, periodontal treatment
- Medical subject headings
- Periodontal Diseases, Periodontal Attachment Loss, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laser therapyProcedure or surgery
adjunctive application of low level laser therapy to non-surgical periodontal treatment
non-surgical periodontal treatmentProcedure or surgery
standart periodontal therapy
| Study group | Role | What they receive |
|---|---|---|
| non-surgical perıodontal treatment | Sham comparator | Not described Receives: Procedure: non-surgical periodontal treatment |
| non-surgical treatment+ low level laser therapy | Experimental | Not described Receives: Procedure: low level laser therapy; Procedure: non-surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in GCF tissue plasminogen activator
Gingival crevicular fluid (GCF) samples were collected before SRP treatment and on days 7, 14 and 30 of follow- up and the change of the related mediator at those time points. The Amount of the related mediator were evaluated using enzyme- linked immunosorbent assay [ELISA] kit.
Total amounts (pg/30 s) of the mediator collected from each sample in a 30- second period were calculated and recorded for analysis.
Measured: baseline and during follow-up visits on Days 7, 14 and 30.
the change in GCF plasminogen activator inhibitor 1
Gingival crevicular fluid (GCF) samples were collected before SRP treatment and on days 7, 14 and 30 of follow- up and the change of the related mediator at those time points. The Amount of the related mediator were evaluated using enzyme- linked immunosorbent assay [ELISA] kit.
Total amounts (pg/30 s) of the mediator collected from each sample in a 30- second period were calculated and recorded for analysis.
Measured: baseline and during follow-up visits on Days 7, 14 and 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Jan 2017
- Primary completion30 Sep 2017
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies 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
- Model description
- a split-mouth randomized controlled clinical study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferda Pamuk Özer, University of Beykent
- Investigators
- Ferda Pamuk Özer, Principal investigator, Beykent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233501
- Sponsor's protocol ID
- interventional
- Status last verified
- Jan 2022
- First submitted
- 13 Jan 2022
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pamuk F, Lutfioglu M, Paksoy T, Koyuncuoglu CZ, Polat NG, Cifcibasi E, Yildirim S, Kantarci A. Impact of low-level laser therapy as an adjunct to non-surgical periodontal treatment on the levels of tissue plasminogen activator and plasminogen activator inhibitor 1 in Stage 3-4, Grade C periodontitis patients: a split-mouth, randomized control study. Clin Oral Investig. 2023 Nov;27(11):6439-6449. doi: 10.1007/s00784-023-05248-z. Epub 2023 Sep 15.
PubMed 37709984
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low-level Laser Therapy on Levels of Tissue Plasminogen Activator and Plasminogen Activator Inhibitor 1 in Gingival Crevicular Fluid of Stage 3-4, Grade C Periodontitis Patients Received Non-surgical Periodontal Treatment.
- ClinicalTrials.gov ID
- NCT05233501
- Acronym / sponsor ID
- interventional
- Conditions
- Periodontal Diseases, Periodontal Attachment Loss, Periodontal Disease, AVDC Stage 3, Periodontal Inflammation, Periodontal Disease, AVDC Stage 4
- Keywords
- periodontitis, lasers, prospective, plasminogen activator inhibitor 1, tissue plasminogen activator, low-level laser therapy, periodontal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 10 Feb 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.
The present study aimed to investigate the effects of low-level laser therapy (LLLT) as an adjunct to non-surgical periodontal treatment (NSPT) on the plasminogen-activating system in Stage 3-4, Grade C periodontitis patients.
Detailed description
Limited data is available regarding the effects of various periodontal treatment protocols on GCF t-PA and PAI-1 levels, and the extent to which LLLT in conjunction with NSPT affects these levels in patients with Stage 3-4, Grade C periodontitis is unknown. Therefore, this study measured standard clinical outcomes and GCF t-PA and PAI-1 levels in patients with Stage 3-4 Grade, C periodontitis in order to assess the use of LLLT as an adjunct to standard NSPT.
This split-mouth study was conducted with 15 Stage 3-4, Grade C periodontitis patients and 15 healthy individuals matched for age and sex. Participants were grouped as follows: Periodontitis/NSPT (Sham); Periodontitis/NSPT+LLLT (LLLT); Periodontally Healthy (Control). LLLT was applied following NSPT and again on post-treatment Days 2 and 7. Clinical parameters were recorded at baseline (i.e. before NSPT) and on Day 30. Gingival crevicular fluid (GCF) samples were collected at baseline and during follow-up visits on Days 7, 14 and 30. GCF t-PA and PAI-1 levels were measured with ELISA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- a split-mouth randomized controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| non-surgical perıodontal treatment | Sham comparator | Procedure: non-surgical periodontal treatment |
| non-surgical treatment+ low level laser therapy | Experimental | Procedure: low level laser therapy, Procedure: non-surgical periodontal treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Stage 3-4, Grade C periodontitis (at least one site with probing depth (PD) and clinical attachment level (CAL) ≥5 mm in their incisors and/or first molars and at least 6 other teeth with similar PD and CAL measurements, with alveolar bone loss confirmed by radiography; familial aggregation;
- presence of ≥16 teeth;
- no periodontal treatment in the 6 months prior to data collection;
- non-smoker
Key exclusion criteria (5 listed)
- systemic problems, including a medical history of cancer, rheumatoid arthritis, diabetes mellitus, or cardiovascular disease;
- compromised immune system;
- pregnancy, menopause, or lactation;
- ongoing drug therapy that might affect the clinical characteristics of periodontitis;
- use of systemic antimicrobials during the 6 weeks prior to data collection
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 |
|---|---|---|
| low level laser therapyadjunctive application of low level laser therapy to non-surgical periodontal treatment | Procedure or surgery | non-surgical treatment+ low level laser therapy |
| non-surgical periodontal treatmentstandart periodontal therapy | Procedure or surgery | non-surgical perıodontal treatment, non-surgical treatment+ low level laser therapy |
Primary outcome
the change in GCF tissue plasminogen activator
Time frame: baseline and during follow-up visits on Days 7, 14 and 30.
Gingival crevicular fluid (GCF) samples were collected before SRP treatment and on days 7, 14 and 30 of follow- up and the change of the related mediator at those time points. The Amount of the related mediator were evaluated using enzyme- linked immunosorbent assay [ELISA] kit. Total amounts (pg/30 s) of the mediator collected from each sample in a 30- second period were calculated and recorded for analysis.
the change in GCF plasminogen activator inhibitor 1
Time frame: baseline and during follow-up visits on Days 7, 14 and 30.
Gingival crevicular fluid (GCF) samples were collected before SRP treatment and on days 7, 14 and 30 of follow- up and the change of the related mediator at those time points. The Amount of the related mediator were evaluated using enzyme- linked immunosorbent assay [ELISA] kit. Total amounts (pg/30 s) of the mediator collected from each sample in a 30- second period were calculated and recorded for analysis.
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 10 Feb 2022.
- Derived from this study: PubMed 37709984Pamuk F, Lutfioglu M, Paksoy T, Koyuncuoglu CZ, Polat NG, Cifcibasi E, Yildirim S, Kantarci A. Impact of low-level laser therapy as an adjunct to non-surgical periodontal treatment on the levels of tissue plasminogen activator and plasminogen activator inhibitor 1 in Stage 3-4, Grade C periodontitis patients: a split-mouth, randomized control study. Clin Oral Investig. 2023 Nov;27(11):6439-6449. doi: 10.1007/s00784-023-05248-z. Epub 2023 Sep 15.
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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.
Ferda Pamuk Özer principal investigator
Beykent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low level laser therapy and non-surgical periodontal treatment in people with Periodontal Diseases and Periodontal Attachment Loss, run by University of Beykent 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 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: finished, as of the sponsor's last update on 10 Feb 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. Some participants in this study may receive a placebo. 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?
the change in GCF tissue plasminogen activator (time frame: baseline and during follow-up visits on Days 7, 14 and 30.). 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?
On the ClinicalTrials.gov record for NCT05233501, which also lists 1 linked publication.
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 10 Feb 2022.