- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05217823
Er:YAG Laser Treatment of Moderate Chronic Periodontitis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- periodontal treatment in the last 12 months;
- systemic diseases;
- systemic medication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Er:YAG laser
Teeth treated with Er:YAG laser
|
Other Names:
|
Active Comparator: Hand instruments
Teeth treated with Gracey curettes
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gingival recession
Time Frame: 1 year
|
Change in GR (measured as a distance between the gingival margin and the cement-enamel junction) using computerised periodontal probe
|
1 year
|
Clinical attachment level
Time Frame: 1 year
|
Change of CAL (measured as a distance between the cement-enamel junction and the depth of the pocket) using computerised periodontal probe
|
1 year
|
Bleeding on probing
Time Frame: 1 year
|
Change in BoP
|
1 year
|
Plaque level
Time Frame: 1 year
|
Change of Plaque index
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Er:YAG - chronic periodontitis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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