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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03387371
Other study ID # LaserPerio001
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 7, 2017
Last updated December 29, 2017
Start date July 18, 2016
Est. completion date January 20, 2018

Study information

Verified date November 2017
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 38
Est. completion date January 20, 2018
Est. primary completion date January 20, 2018
Accepts healthy volunteers No
Gender All
Age group 28 Years to 58 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ultrasonics
ultrasonic scalers
Gracey Curettes
Spesific gracey curettes
Er:YAG Laser
2940 nm wavelenght Er:YAG laser

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Outcome

Type Measure Description Time frame Safety issue
Primary Probing Pocket Depth 3 to measure the probing pocket depth of all teeth 3. month
Primary Clinic Attachment Level 3 to measure the Clinic Attachment Level of all teeth 3. month
Primary Subgingival Plak Sample 1 quantitative changes on red complex bacterias 1. month
Primary Probing Pocket Depth 6 to measure theProbing Pocket Depth of all teeth 6. month
Primary Clinic Attachment Level 6 to measure the Clinic Attachment Level of all teeth 6. month
Primary Subgingival Plak Sample 3 quantitative changes on red complex bacterias 3. month
Primary Subgingival Plak Sample 6 quantitative changes on red complex bacterias 6. month
Secondary Bleeding On Probing 3 to record the Bleeding On Probing of all teeth 3. month
Secondary Bleeding On Probing 6 to record the Bleeding On Probing of all teeth 6. month
Secondary Plak Index 3 to record the plak index of all teeth 3. month
Secondary Plak Index 6 to record the plak index of all teeth 6. month
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