Chronic PeriodontitisNCT02817152
Low-level Laser Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics
A study testing Periodontal ultrasonic debridement and Debridement plus low-level laser therapy in people with Chronic Periodontitis and Diabetes Mellitus, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
Trial summary
The aim of this study was to investigate the local effect of adjunct low-level laser therapy (LLLT) for the treatment of moderate to severe chronic periodontitis in type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Chronic Periodontitis, Diabetes Mellitus
- What is being tested?
- Periodontal ultrasonic debridement and Debridement plus low-level laser therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Sep 2015
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 35; diagnosis of type 2 diabetes for ≥ 5 years; diabetes treatment with oral hypoglycemic agents or insulin supplementation and diet; glycated hemoglobin (HbA1c) levels from 6.5% to 11%; at least 15 teeth (excluding third molars and teeth indicated for extraction); and moderate to severe generalized chronic periodontitis.
Who cannot join
- The exclusion criteria were: medical conditions that required prophylactic antimicrobial coverage; periodontal mechanical therapy in the previous 6 months; antimicrobial therapies in the previous 6 months; anti-inflammatory therapies in the previous 6 months; systemic conditions other than diabetes that could affect the progression of chronic periodontitis; current use of medication that could interfere with periodontal response to treatment; pregnancy or lactation; and smoking.
About this study
Official title: Low-level Laser Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics: Split-mouth Double-blind Randomized Clinical Trial
The aim of this study was to investigate the local effect of adjunct low-level laser therapy (LLLT) for the treatment of moderate to severe chronic periodontitis in type 2 diabetic patients.
Read the detailed description
The aim of this study was to investigate the local effect of adjunct low-level laser therapy (LLLT) for the treatment of moderate to severe chronic periodontitis in type 2 diabetic patients. Twenty poorly-controlled type 2 diabetic patients with moderate to severe generalized chronic periodontitis were selected. Two periodontal pockets with Probing Depth (PD) and Clinical Attachment Level (CAL) ≥ 5mm received ultrasonic periodontal debridement (UPD) only (control group) or UPD with LLLT (test group). Clinical measures, such as PD, CAL, Gingival Recession (GR), Bleeding on Probing (BoP), and Plaque Index (PI), were collected and compared at baseline, 30, 90, and 180 days. The adjunct application of LLLT to UPD had no additional benefits for PD reduction and CAL gain, meaning that both investigated therapies were efficient for the treatment of chronic periodontitis in type 2 diabetics. Nevertheless, additional LLLT application showed better results for GR then UPD only.
- Conditions
- Chronic Periodontitis, Diabetes Mellitus
- Being tested
- Periodontal ultrasonic debridement, Debridement plus low-level laser therapy
- Keywords
- periodontal treatment, low-level light therapy
- Medical subject headings
- Chronic Periodontitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal ultrasonic debridementProcedure or surgery
Also called periodontal debridement, ultrasonic debridement
Periodontal pockets received periodontal ultrasonic debridement intervention.
Debridement plus low-level laser therapyDevice
Also called low-level light therapy, low-power laser therapy, low-intensity laser therapy
Ultrasonic debridement plus low-level laser therapy.
| Study group | Role | What they receive |
|---|---|---|
| Periodontal ultrasonic debridement | Sham comparator | Periodontal pockets received ultrasonic periodontal debridement intervention. Receives: Procedure: Periodontal ultrasonic debridement |
| Low-level laser therapy | Active comparator | Periodontal pockets received ultrasonic periodontal debridement plus low-level laser therapy intervention. Receives: Procedure: Periodontal ultrasonic debridement; Device: Debridement plus low-level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth change from baseline to 30, 90, and 180 days through periodontal probing
Measured: baseline, 30 days, 90 days, 180 days
Secondary outcomes (4)
Clinical attachment level change from baseline to 30, 90, and 180 days through periodontal probing
Measured: baseline, 30 days, 90 days, 180 days
Gingival recession change from baseline to 30, 90, and 180 days through periodontal probing
Measured: baseline, 30 days, 90 days, 180 days
Bleeding on probing change from baseline to 30, 90, and 180 days through periodontal probing
Measured: baseline, 30 days, 90 days, 180 days
Plaque index change from baseline to 30, 90, and 180 days through periodontal probing
Measured: baseline, 30 days, 90 days, 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startFeb 2014
- Primary completionSep 2015
- Study completionSep 2015
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 Chronic PeriodontitisStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Nídia Cristina Castro dos Santos, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Mauro P Santamaria, DDS, MS, PhD, Study director, UPECLIN HC FM Botucatu Unesp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817152
- Sponsor's protocol ID
- NCSlaser
- Status last verified
- Jul 2016
- First submitted
- 10 Jun 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Aykol G, Baser U, Maden I, Kazak Z, Onan U, Tanrikulu-Kucuk S, Ademoglu E, Issever H, Yalcin F. The effect of low-level laser therapy as an adjunct to non-surgical periodontal treatment. J Periodontol. 2011 Mar;82(3):481-8. doi: 10.1902/jop.2010.100195. Epub 2010 Oct 8.
PubMed 20932157
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-level Laser Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics: Split-mouth Double-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02817152
- Acronym / sponsor ID
- NCSlaser
- Conditions
- Chronic Periodontitis, Diabetes Mellitus
- Keywords
- periodontal treatment, low-level light therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Feb 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 29 Jun 2016 (estimated)
- 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 aim of this study was to investigate the local effect of adjunct low-level laser therapy (LLLT) for the treatment of moderate to severe chronic periodontitis in type 2 diabetic patients.
Detailed description
The aim of this study was to investigate the local effect of adjunct low-level laser therapy (LLLT) for the treatment of moderate to severe chronic periodontitis in type 2 diabetic patients. Twenty poorly-controlled type 2 diabetic patients with moderate to severe generalized chronic periodontitis were selected. Two periodontal pockets with Probing Depth (PD) and Clinical Attachment Level (CAL) ≥ 5mm received ultrasonic periodontal debridement (UPD) only (control group) or UPD with LLLT (test group). Clinical measures, such as PD, CAL, Gingival Recession (GR), Bleeding on Probing (BoP), and Plaque Index (PI), were collected and compared at baseline, 30, 90, and 180 days. The adjunct application of LLLT to UPD had no additional benefits for PD reduction and CAL gain, meaning that both investigated therapies were efficient for the treatment of chronic periodontitis in type 2 diabetics. Nevertheless, additional LLLT application showed better results for GR then UPD only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontal ultrasonic debridement | Sham comparator | Procedure: Periodontal ultrasonic debridementPeriodontal pockets received ultrasonic periodontal debridement intervention. |
| Low-level laser therapy | Active comparator | Procedure: Periodontal ultrasonic debridement, Device: Debridement plus low-level laser therapyPeriodontal pockets received ultrasonic periodontal debridement plus low-level laser therapy intervention. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age ≥ 35; diagnosis of type 2 diabetes for ≥ 5 years; diabetes treatment with oral hypoglycemic agents or insulin supplementation and diet; glycated hemoglobin (HbA1c) levels from 6.5% to 11%; at least 15 teeth (excluding third molars and teeth indicated for extraction); and moderate to severe generalized chronic periodontitis.
Key exclusion criteria (1 listed)
- The exclusion criteria were: medical conditions that required prophylactic antimicrobial coverage; periodontal mechanical therapy in the previous 6 months; antimicrobial therapies in the previous 6 months; anti-inflammatory therapies in the previous 6 months; systemic conditions other than diabetes that could affect the progression of chronic periodontitis; current use of medication that could interfere with periodontal response to treatment; pregnancy or lactation; and smoking.
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 |
|---|---|---|
| Periodontal ultrasonic debridementAlso: periodontal debridement, ultrasonic debridementPeriodontal pockets received periodontal ultrasonic debridement intervention. | Procedure or surgery | Low-level laser therapy, Periodontal ultrasonic debridement |
| Debridement plus low-level laser therapyAlso: low-level light therapy, low-power laser therapy, low-intensity laser therapyUltrasonic debridement plus low-level laser therapy. | Device | Low-level laser therapy |
Primary outcome
Probing depth change from baseline to 30, 90, and 180 days through periodontal probing
Time frame: baseline, 30 days, 90 days, 180 days
4 secondary outcomes
Clinical attachment level change from baseline to 30, 90, and 180 days through periodontal probing
Time frame: baseline, 30 days, 90 days, 180 days
Gingival recession change from baseline to 30, 90, and 180 days through periodontal probing
Time frame: baseline, 30 days, 90 days, 180 days
Bleeding on probing change from baseline to 30, 90, and 180 days through periodontal probing
Time frame: baseline, 30 days, 90 days, 180 days
Plaque index change from baseline to 30, 90, and 180 days through periodontal probing
Time frame: baseline, 30 days, 90 days, 180 days
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 12 Jul 2016.
- Results publication: PubMed 20932157Aykol G, Baser U, Maden I, Kazak Z, Onan U, Tanrikulu-Kucuk S, Ademoglu E, Issever H, Yalcin F. The effect of low-level laser therapy as an adjunct to non-surgical periodontal treatment. J Periodontol. 2011 Mar;82(3):481-8. doi: 10.1902/jop.2010.100195. Epub 2010 Oct 8.
- Individual participant dataSharing planned: Undecided
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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.
Mauro P Santamaria, DDS, MS, PhD study director
UPECLIN HC FM Botucatu Unesp
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal ultrasonic debridement and Debridement plus low-level laser therapy in people with Chronic Periodontitis and Diabetes Mellitus, run by Universidade Estadual Paulista Júlio de Mesquita Filho.
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 1 inclusion and 1 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 12 Jul 2016. 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. 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?
Probing depth change from baseline to 30, 90, and 180 days through periodontal probing (time frame: baseline, 30 days, 90 days, 180 days). 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 NCT02817152, 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 12 Jul 2016.