Chronic Periodontitis, Generalized, ModerateNCT05217823
Er:YAG Laser Treatment of Moderate Chronic Periodontitis
A study testing Er:YAG laser and hand instruments in people with Chronic Periodontitis, Generalized, Moderate, run by Plovdiv Medical University.
Trial summary
The Er:YAG laser possesses specific characteristics allowing to be used in non-surgical periodontal treatment. The aim of the resent study was to evaluate the long-term clinical effectiveness of Er:YAG laser monotherapy in the treatment of moderate chronic periodontitis and to compare it with conventional hand… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis, Generalized, Moderate
- What is being tested?
- Er:YAG laser and hand instruments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Feb 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least two teeth per quadrant with PPD between 3,6 mm and 6,4 mm;
- loss of clinical attachment up to 4 mm
- bleeding on probing
Who cannot join
- periodontal treatment in the last 12 months;
- systemic diseases;
- systemic medication
About this study
Official title: Long-term Stability of Er:YAG Laser Non-surgical Periodontal Treatment
The Er:YAG laser possesses specific characteristics allowing to be used in non-surgical periodontal treatment. The aim of the resent study was to evaluate the long-term clinical effectiveness of Er:YAG laser monotherapy in the treatment of moderate chronic periodontitis and to compare it with conventional hand instrumentation.
MATERIALS AND METHODS: 451 teeth (1,099 periodontal pockets) from 30 patients with moderate chronic periodontitis (initial probing pocket depth 4 to 6 mm) were allocated for subgingival scaling and root planing in two groups - hand instrumentation (control) and Er:YAG laser instrumentation with 100mJ/15Hz (test). Using a computerized periodontal probe, patients were examined for probing pocket depth (PPD), gingival recession (GR), clinical attachment level (CAL), bleeding on probing (BOP), plaque presence (FMPS) at baseline, one, three, six and 12 months after instrumentation.
- Being tested
- Er:YAG laser, hand instruments
- Keywords
- Lasers, Periodontitis, Root planing, Treatment outcome
- Medical subject headings
- Chronic Periodontitis, Lymphoma, Follicular, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er:YAG laserDevice
Also called Er:YAG laser, LiteTouch, Light Instruments, Israel
hand instrumentsOther
Also called Gracey curettes
| Study group | Role | What they receive |
|---|---|---|
| Er:YAG laser | Experimental | Teeth treated with Er:YAG laser Receives: Device: Er:YAG laser |
| Hand instruments | Active comparator | Teeth treated with Gracey curettes Receives: Other: hand instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth
Change in PPD (measured as a distance between the gingival margin and the depth of the pocket) using computerised periodontal probe
Measured: 1 year
Secondary outcomes (4)
Gingival recession
Change in GR (measured as a distance between the gingival margin and the cement-enamel junction) using computerised periodontal probe
Measured: 1 year
Clinical attachment level
Change of CAL (measured as a distance between the cement-enamel junction and the depth of the pocket) using computerised periodontal probe
Measured: 1 year
Bleeding on probing
Change in BoP
Measured: 1 year
Plaque level
Change of Plaque index
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study startJan 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Periodontitis, Generalized, ModerateStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Plovdiv Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blagovesta Yaneva, Plovdiv Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217823
- Sponsor's protocol ID
- Er:YAG - chronic periodontitis
- Status last verified
- Feb 2022
- First submitted
- 4 Jan 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Stability of Er:YAG Laser Non-surgical Periodontal Treatment
- ClinicalTrials.gov ID
- NCT05217823
- Acronym / sponsor ID
- Er:YAG - chronic periodontitis
- Keywords
- Lasers, Periodontitis, Root planing, Treatment outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Plovdiv Medical UniversityUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 1 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 Er:YAG laser possesses specific characteristics allowing to be used in non-surgical periodontal treatment. The aim of the resent study was to evaluate the long-term clinical effectiveness of Er:YAG laser monotherapy in the treatment of moderate chronic periodontitis and to compare it with conventional hand instrumentation.
MATERIALS AND METHODS: 451 teeth (1,099 periodontal pockets) from 30 patients with moderate chronic periodontitis (initial probing pocket depth 4 to 6 mm) were allocated for subgingival scaling and root planing in two groups - hand instrumentation (control) and Er:YAG laser instrumentation with 100mJ/15Hz (test). Using a computerized periodontal probe, patients were examined for probing pocket depth (PPD), gingival recession (GR), clinical attachment level (CAL), bleeding on probing (BOP), plaque presence (FMPS) at baseline, one, three, six and 12 months after instrumentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Er:YAG laser | Experimental | Device: Er:YAG laserTeeth treated with Er:YAG laser |
| Hand instruments | Active comparator | Other: hand instrumentsTeeth treated with Gracey curettes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least two teeth per quadrant with PPD between 3,6 mm and 6,4 mm;
- loss of clinical attachment up to 4 mm
- bleeding on probing
Key exclusion criteria (3 listed)
- periodontal treatment in the last 12 months;
- systemic diseases;
- systemic medication
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 |
|---|---|---|
| Er:YAG laserAlso: Er:YAG laser, LiteTouch, Light Instruments, Israel | Device | Er:YAG laser |
| hand instrumentsAlso: Gracey curettes | Other | Hand instruments |
Primary outcome
Probing pocket depth
Time frame: 1 year
Change in PPD (measured as a distance between the gingival margin and the depth of the pocket) using computerised periodontal probe
4 secondary outcomes
Gingival recession
Time frame: 1 year
Clinical attachment level
Time frame: 1 year
Bleeding on probing
Time frame: 1 year
Plaque level
Time frame: 1 year
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 2022.
- 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 Er:YAG laser and hand instruments in people with Chronic Periodontitis, Generalized, Moderate, run by Plovdiv Medical 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 3 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 23 Feb 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?
Probing pocket depth (time frame: 1 year). 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 2022.