N/A
N=52
Treatment of Periodontitis With Er:YAG Laser
Generalized Moderate Chronic Periodontitis · Generalized Severe Chronic Periodontitis · Periodontal Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03628872 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Change in Clinical Attachment Level (CAL) — 3.5; 3.4 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Scaling and root planing (Procedure); Er:YAG Laser (Device); Hand instruments (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Clinical Attachment Level (CAL) |
3.5; 3.4 | — |
| PRIMARY Change in Pocket Depth (PD) |
3.12; 3.13 | — |
| SECONDARY Plaque Index (PI) |
61.16; 65.22 | — |
| SECONDARY Bleeding on Probing (BoP) |
29.21; 31.34 | — |
| SECONDARY Average Duration of Treatment |
92.04; 54.15 | — |
| SECONDARY Number of Participants Who Preferred Modality |
21; 21; 0; 0; 5; 5 | — |
| SECONDARY Number of Patients Who Experienced a Better Improvement in Sensitivity |
0; 17 | — |
Summary
The purpose of this research project is to gain information on the best and most comfortable way to treat the periodontal disease. The main objective is to compare the efficacy of conventional scaling and root planning compared to laser scaling for the non-surgical treatment of periodontal disease. Both therapies have shown to be effective and are regularly used in the dental clinic.
Eligibility Criteria
Inclusion Criteria
- Signed and dated Informed Consent
- Good general health
- Participants > 18 years of age
- Participants with > 20 teeth with 5 teeth, including at least 1 molar, in each quadrant of the mouth
- Participants with > 30% of the present teeth with Probing depths of > 4mm and Bleeding on Probing
- Non-smoker and former smokers (stopped smoking > 1 year)
- Participants that have not received any periodontal treatment in the past 3 months
Exclusion Criteria
- Participants with uncontrolled systemic diseases that could affect the treatment outcome such as Diabetes with HbA1c > 7.0 percent, rheumatoid arthritis, immunosuppression, HIV with detectable viral loads
- Participants requiring antibiotic prophylaxis for any cardiovascular conditions or after any transplant and/or replacement procedures
- Pregnant women
- Patients treated with systemic antibiotic therapy of periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration
- Patients being chronically (two weeks or more) treated with any NSAIDs, steroids or any medications known to affect soft tissue condition (excluding treatment with Acetylsalicylic acid < 100 mg/day)
- Presence of orthodontic appliances, or any removable appliances that impinges on the tissues being assessed.
- Presence of soft or hard tissue tumors of the oral cavity
- The presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study
Data sourced from ClinicalTrials.gov (NCT03628872). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.