Diabetes MellitusNCT03444363
Periodontal Treatment With Diode Laser in the Patients With Diabetes Melitus
A study testing Laser group in people with Diabetes Mellitus and Periodontal Disease, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the effects of diode laser (DL) in addition to non-surgical periodontal treatment on periodontal parameters, systemic inflammatory response, and serum hemoglobin A1c (HbA1c) level in patients with uncontrolled type 2 diabetes mellitus (T2DM) and chronic periodontitis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Periodontal Disease
- What is being tested?
- Laser group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2013to 23 Dec 2014
- 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
- Having a diagnosis of type-2 DM according to the ADA criteria for at least two years before the study, HbA1c⩾7%,28
- Having no change in antidiabetic drugs in the last 3 months,
- Having no major diabetes complications (because chronic complications of diabetes complicate metabolic control),
- Presence of generalized CP,29
- Presence of an area with a pocket depth of 4-7 mm in at least four teeth in the upper jaw,
- Presence of at least 20 teeth in the mouth,
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- Having no any systemic illness except for DM,
- Having no smoke,
- Receiving no periodontal treatment in the last 12 months,
- Receiving no antibiotics or anti-inflammatory drugs for a long period in the last 6 months,
- Not being pregnant or not to breastfeed,
- Having no third molars.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Long-Term Effects of Diode Laser Application on Periodontal Healing, Serum C-Reactive Protein and HbA1c Levels in Periodontal Treatment of Uncontrolled Type-2 Diabetic Subjects With Chronic Periodontitis
This study aimed to investigate the effects of diode laser (DL) in addition to non-surgical periodontal treatment on periodontal parameters, systemic inflammatory response, and serum hemoglobin A1c (HbA1c) level in patients with uncontrolled type 2 diabetes mellitus (T2DM) and chronic periodontitis.
Read the detailed description
This study was designed as a randomized, controlled, full-mouth, 6-month clinical trial. 37 patients (20 women and 17 men) with uncontrolled T2DM and chronic periodontitis who were selected from among those admitting to Dentistry Faculty of Inonu University and Turgut Ozal Medical Center completed this study. The patients were divided into two groups. The individuals in the control group underwent placebo laser treatment in addition to scaling and root planing (SRP). The individuals in the study group underwent DL (1 W power) in addition to SRP. Clinical index measurements were performed before treatment (T0), 3 months after treatment (T1), and 6 months after treatment (T2). Plaque index (PI), gingival index (GI), bleeding on probing (BOP), clinical attachment level (CAL), and probing depth (PD) were measured to determine periodontal status. HbA1c and C-reactive protein (CRP) levels were also analyzed using blood samples.
- Conditions
- Diabetes Mellitus, Periodontal Disease
- Being tested
- Laser group, Control group
- Keywords
- laser, periodontal treatment, systemic inflammation, glycemic control
- Medical subject headings
- Diabetes Mellitus, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser groupDevice
Also called Gigaa Laser
Laser application in addition to SRP
Control groupDevice
Placebo laser application in addition to SRP
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | SRP plus diode laser (810 nm wavelength, 1 W power) Receives: Device: Laser group |
| Control group | Active comparator | SRP plus placebo Receives: Device: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory findings
Serum HbA1c levels were measured using the high-performance liquid chromatography method.
Measured: Six months
Secondary outcomes (1)
Clinical findings
Probing depth (PD) was measured the distance between the gingival margin and the deepest aspect of the pocket (mm).
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start20 Sep 2013
- Primary completion15 Feb 2014
- Study completion23 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- This study was designed as a randomized, controlled.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abubekir Eltas, Çanakkale Onsekiz Mart University
- Investigators
- Mustafa O Uslu, Dr., Study chair, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444363
- Sponsor's protocol ID
- 2013/104
- Status last verified
- Feb 2018
- First submitted
- 15 Feb 2018
- Last updated
- 23 Feb 2018
- 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 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Long-Term Effects of Diode Laser Application on Periodontal Healing, Serum C-Reactive Protein and HbA1c Levels in Periodontal Treatment of Uncontrolled Type-2 Diabetic Subjects With Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT03444363
- Acronym / sponsor ID
- 2013/104
- Conditions
- Diabetes Mellitus, Periodontal Disease
- Keywords
- laser, periodontal treatment, systemic inflammation, glycemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 20 Sep 2013 (actual)
- Primary completion
- 15 Feb 2014 (actual)
- Study completion
- 23 Dec 2014 (actual)
- First posted
- 23 Feb 2018 (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.
This study aimed to investigate the effects of diode laser (DL) in addition to non-surgical periodontal treatment on periodontal parameters, systemic inflammatory response, and serum hemoglobin A1c (HbA1c) level in patients with uncontrolled type 2 diabetes mellitus (T2DM) and chronic periodontitis.
Detailed description
This study was designed as a randomized, controlled, full-mouth, 6-month clinical trial. 37 patients (20 women and 17 men) with uncontrolled T2DM and chronic periodontitis who were selected from among those admitting to Dentistry Faculty of Inonu University and Turgut Ozal Medical Center completed this study. The patients were divided into two groups. The individuals in the control group underwent placebo laser treatment in addition to scaling and root planing (SRP). The individuals in the study group underwent DL (1 W power) in addition to SRP. Clinical index measurements were performed before treatment (T0), 3 months after treatment (T1), and 6 months after treatment (T2). Plaque index (PI), gingival index (GI), bleeding on probing (BOP), clinical attachment level (CAL), and probing depth (PD) were measured to determine periodontal status. HbA1c and C-reactive protein (CRP) levels were also analyzed using blood samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study was designed as a randomized, controlled.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Laser groupSRP plus diode laser (810 nm wavelength, 1 W power) |
| Control group | Active comparator | Device: Control groupSRP plus placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Having a diagnosis of type-2 DM according to the ADA criteria for at least two years before the study, HbA1c⩾7%,28
- Having no change in antidiabetic drugs in the last 3 months,
- Having no major diabetes complications (because chronic complications of diabetes complicate metabolic control),
- Presence of generalized CP,29
- Presence of an area with a pocket depth of 4-7 mm in at least four teeth in the upper jaw,
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Laser groupAlso: Gigaa LaserLaser application in addition to SRP | Device | Study group |
| Control groupPlacebo laser application in addition to SRP | Device | Control group |
Primary outcome
Laboratory findings
Time frame: Six months
Serum HbA1c levels were measured using the high-performance liquid chromatography method.
1 secondary outcome
Clinical findings
Time frame: Six months
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 23 Feb 2018.
- 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.
Mustafa O Uslu, Dr. study chair
Inonu 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 Laser group in people with Diabetes Mellitus and Periodontal Disease, run by Çanakkale Onsekiz Mart 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 12 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 23 Feb 2018. 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?
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?
Laboratory findings (time frame: Six 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 23 Feb 2018.