Laser Assisted Nonsurgical Periodontal Treatment

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Device: Ultrasonics; Device: Gracey Curettes; Device: Er:YAG Laser

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasonics & Gracey Curettes; Scaling and root planning is done with ultrasonics and gracey curettes in 24 hours with two visits.	Device: Ultrasonics; ultrasonic scalers; Device: Gracey Curettes; Spesific gracey curettes
Experimental: Ultrasonics & Gracey Curettes & Laser; Scaling and root planning is done with ultrasonics, gracey curettes and Er:YAG laser in 24 hours with two visits.	Device: Gracey Curettes; Spesific gracey curettes; Device: Er:YAG Laser; 2940 nm wavelenght Er:YAG laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing Pocket Depth 3	to measure the probing pocket depth of all teeth	3. month
Clinic Attachment Level 3	to measure the Clinic Attachment Level of all teeth	3. month
Subgingival Plak Sample 1	quantitative changes on red complex bacterias	1. month
Probing Pocket Depth 6	to measure theProbing Pocket Depth of all teeth	6. month
Clinic Attachment Level 6	to measure the Clinic Attachment Level of all teeth	6. month
Subgingival Plak Sample 3	quantitative changes on red complex bacterias	3. month
Subgingival Plak Sample 6	quantitative changes on red complex bacterias	6. month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding On Probing 3	to record the Bleeding On Probing of all teeth	3. month
Bleeding On Probing 6	to record the Bleeding On Probing of all teeth	6. month
Plak Index 3	to record the plak index of all teeth	3. month
Plak Index 6	to record the plak index of all teeth	6. month

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2016
• Primary Completion (Anticipated): January 20, 2018
• Study Completion (Anticipated): January 20, 2018

Study Registration Dates

• First Submitted: November 7, 2017
• First Submitted That Met QC Criteria: December 29, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): January 2, 2018
• Last Update Submitted That Met QC Criteria: December 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: chronic periodontitis, laser
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: LaserPerio001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No