Chronic PeriodontitisNCT03387371
Laser Assisted Nonsurgical Periodontal Treatment
A study testing Ultrasonics, Gracey Curettes and Er:YAG Laser in people with Chronic Periodontitis, run by Bezmialem Vakif University.
Trial summary
Periodontitis is a chronic inflammatory disease caused by mixed infections with the subgingival microbiota being organized as a biofilm that, if untreated, may result in breakdown of the periodontal tissues in susceptible individuals. Read more about this study
- Who is it for?
- Ages 28 to 58 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Ultrasonics, Gracey Curettes and Er:YAG Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 18 Jul 2016to 20 Jan 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 28 to 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Greater than 25 years, Clinical diagnosis of moderate to advanced chronic periodontitis, Pocket depth ≥ 5 mm or clinic attachment level ≥ 4 mm at least in two interproximal areas (not on the same tooth), Along with very good oral hygiene scores (GI≤1and PI≤1), At least 4 teeth in each quadrant, Teeth with subgingival plaque sample is collected has no restoration or prothesis
Who cannot join
- Periodontal treatment ( root planning or surgical periodontal treatment) had done before, Systemic disease that could influence the outcome of periodontal therapy, Prophylaxis regime mandatory during periodontal treatment, Use of any drug that could influence the outcome of periodontal therapy, Use of antibiotics within the last 3 months, Use of anti-inflammatory drugs within the last 3 months, Use of removable prothesis Pregnancy, lactation or use of hormone contraceptives, Smoking
About this study
Official title: Clinical and Microbiologic Effects of Nonsurgical Periodontal Treatment Combined With an Erbium: Yttrium Aluminium Garnet Laser
Periodontitis is a chronic inflammatory disease caused by mixed infections with the subgingival microbiota being organized as a biofilm that, if untreated, may result in breakdown of the periodontal tissues in susceptible individuals. Evidence from intervention studies shows that mechanical root debridement significantly improves periodontal health by halting the progression of periodontal tissue breakdown. In order to improve effectiveness and efficacy of the removal of the subgingival biofilm, Er:YAG laser therapy has recently been recommended as an alternative to conventional scaling procedures.
- Conditions
- Chronic Periodontitis
- Being tested
- Ultrasonics, Gracey Curettes, Er:YAG Laser
- Keywords
- chronic periodontitis, laser
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonicsDevice
ultrasonic scalers
Gracey CurettesDevice
Spesific gracey curettes
Er:YAG LaserDevice
2940 nm wavelenght Er:YAG laser
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonics & Gracey Curettes | Active comparator | Scaling and root planning is done with ultrasonics and gracey curettes in 24 hours with two visits. Receives: Device: Ultrasonics; Device: Gracey Curettes |
| Ultrasonics & Gracey Curettes & Laser | Experimental | Scaling and root planning is done with ultrasonics, gracey curettes and Er:YAG laser in 24 hours with two visits. Receives: Device: Gracey Curettes; Device: Er:YAG Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Pocket Depth 3
to measure the probing pocket depth of all teeth
Measured: 3. month
Clinic Attachment Level 3
to measure the Clinic Attachment Level of all teeth
Measured: 3. month
Subgingival Plak Sample 1
quantitative changes on red complex bacterias
Measured: 1. month
Probing Pocket Depth 6
to measure theProbing Pocket Depth of all teeth
Measured: 6. month
Clinic Attachment Level 6
to measure the Clinic Attachment Level of all teeth
Measured: 6. month
Subgingival Plak Sample 3
quantitative changes on red complex bacterias
Measured: 3. month
Subgingival Plak Sample 6
quantitative changes on red complex bacterias
Measured: 6. month
Secondary outcomes (4)
Bleeding On Probing 3
to record the Bleeding On Probing of all teeth
Measured: 3. month
Bleeding On Probing 6
to record the Bleeding On Probing of all teeth
Measured: 6. month
Plak Index 3
to record the plak index of all teeth
Measured: 3. month
Plak Index 6
to record the plak index of all teeth
Measured: 6. month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start18 Jul 2016
- Primary completion20 Jan 2018 (estimated)
- Study completion20 Jan 2018 (estimated)
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.
- More trials run by Bezmialem Vakif 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387371
- Sponsor's protocol ID
- LaserPerio001
- Status last verified
- Nov 2017
- First submitted
- 7 Nov 2017
- Last updated
- 2 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zengin Celik T, Saglam E, Ercan C, Akbas F, Nazaroglu K, Tunali M. Clinical and Microbiological Effects of the Use of Erbium: Yttrium-Aluminum-Garnet Laser on Chronic Periodontitis in Addition to Nonsurgical Periodontal Treatment: A Randomized Clinical Trial-6 Months Follow-Up. Photobiomodul Photomed Laser Surg. 2019 Mar;37(3):182-190. doi: 10.1089/photob.2018.4510. Epub 2019 Feb 21.
PubMed 31050949
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiologic Effects of Nonsurgical Periodontal Treatment Combined With an Erbium: Yttrium Aluminium Garnet Laser
- ClinicalTrials.gov ID
- NCT03387371
- Acronym / sponsor ID
- LaserPerio001
- Conditions
- Chronic Periodontitis
- Keywords
- chronic periodontitis, laser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 18 Jul 2016 (actual)
- Primary completion
- 20 Jan 2018 (estimated)
- Study completion
- 20 Jan 2018 (estimated)
- First posted
- 2 Jan 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.
Periodontitis is a chronic inflammatory disease caused by mixed infections with the subgingival microbiota being organized as a biofilm that, if untreated, may result in breakdown of the periodontal tissues in susceptible individuals. Evidence from intervention studies shows that mechanical root debridement significantly improves periodontal health by halting the progression of periodontal tissue breakdown. In order to improve effectiveness and efficacy of the removal of the subgingival biofilm, Er:YAG laser therapy has recently been recommended as an alternative to conventional scaling procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasonics & Gracey Curettes | Active comparator | Device: Ultrasonics, Device: Gracey CurettesScaling and root planning is done with ultrasonics and gracey curettes in 24 hours with two visits. |
| Ultrasonics & Gracey Curettes & Laser | Experimental | Device: Gracey Curettes, Device: Er:YAG LaserScaling and root planning is done with ultrasonics, gracey curettes and Er:YAG laser in 24 hours with two visits. |
Who may qualify
- Ages
- 28 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Greater than 25 years, Clinical diagnosis of moderate to advanced chronic periodontitis, Pocket depth ≥ 5 mm or clinic attachment level ≥ 4 mm at least in two interproximal areas (not on the same tooth), Along with very good oral hygiene scores (GI≤1and PI≤1), At least 4 teeth in each quadrant, Teeth with subgingival plaque sample is collected has no restoration or prothesis
Key exclusion criteria (1 listed)
- Periodontal treatment ( root planning or surgical periodontal treatment) had done before, Systemic disease that could influence the outcome of periodontal therapy, Prophylaxis regime mandatory during periodontal treatment, Use of any drug that could influence the outcome of periodontal therapy, Use of antibiotics within the last 3 months, Use of anti-inflammatory drugs within the last 3 months, Use of removable prothesis Pregnancy, lactation or use of hormone contraceptives, 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 |
|---|---|---|
| Ultrasonicsultrasonic scalers | Device | Ultrasonics & Gracey Curettes |
| Gracey CurettesSpesific gracey curettes | Device | Ultrasonics & Gracey Curettes, Ultrasonics & Gracey Curettes & Laser |
| Er:YAG Laser2940 nm wavelenght Er:YAG laser | Device | Ultrasonics & Gracey Curettes & Laser |
Primary outcome
Probing Pocket Depth 3
Time frame: 3. month
to measure the probing pocket depth of all teeth
Clinic Attachment Level 3
Time frame: 3. month
to measure the Clinic Attachment Level of all teeth
Subgingival Plak Sample 1
Time frame: 1. month
quantitative changes on red complex bacterias
Probing Pocket Depth 6
Time frame: 6. month
to measure theProbing Pocket Depth of all teeth
Clinic Attachment Level 6
Time frame: 6. month
to measure the Clinic Attachment Level of all teeth
Subgingival Plak Sample 3
Time frame: 3. month
quantitative changes on red complex bacterias
Subgingival Plak Sample 6
Time frame: 6. month
quantitative changes on red complex bacterias
4 secondary outcomes
Bleeding On Probing 3
Time frame: 3. month
Bleeding On Probing 6
Time frame: 6. month
Plak Index 3
Time frame: 3. month
Plak Index 6
Time frame: 6. month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Derived from this study: PubMed 31050949Zengin Celik T, Saglam E, Ercan C, Akbas F, Nazaroglu K, Tunali M. Clinical and Microbiological Effects of the Use of Erbium: Yttrium-Aluminum-Garnet Laser on Chronic Periodontitis in Addition to Nonsurgical Periodontal Treatment: A Randomized Clinical Trial-6 Months Follow-Up. Photobiomodul Photomed Laser Surg. 2019 Mar;37(3):182-190. doi: 10.1089/photob.2018.4510. Epub 2019 Feb 21.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonics, Gracey Curettes and Er:YAG Laser in people with Chronic Periodontitis, run by Bezmialem Vakif 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 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: status not confirmed, as of the sponsor's last update on 2 Jan 2018. 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?
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?
Probing Pocket Depth 3 (time frame: 3. month). The study lists 7 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 NCT03387371, 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 2 Jan 2018.