NCT02851823

Brief Summary

The aim of the present study was to compare the effectiveness of combined Er:YAG and Nd:YAG laser therapy to that of scaling and root planning with hand instruments in nonsurgical treatment of chronic periodontitis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 7, 2017

Completed
Last Updated

November 7, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

July 25, 2016

Results QC Date

March 2, 2017

Last Update Submit

October 8, 2017

Conditions

Keywords

Er-YAG lasersNd-YAG laserschronic periodontitisnonsurgical periodontal debridement

Outcome Measures

Primary Outcomes (2)

  • Clinical Attachment Level Change for Moderately Deep Pockets (4 mm≤PD≤6 mm)

    Change in clinical attachment level for moderately deep pockets (4 mm≤PD≤6 mm) between baseline and 1 month Change in clinical attachment level for moderately deep pockets (4 mm≤PD≤6 mm) between baseline and 3 month

    Baseline, 1 and 3 months

  • Clinical Attachment Level Change for Deep Pockets (7 mm≤PD)

    Change in clinical attachment level for deep pockets (7 mm≤PD) between baseline and 1 month. Change in clinical attachment level for deep pockets (7 mm≤PD) between baseline and 3 month.

    Baseline, 1 and 3 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Mechanical periodontal treatment: Scaling and root planing were performed with periodontal curettes until the operator feels that root surface is clean, hard and smooth.

Device: Periodontal curettes

Test Group

EXPERIMENTAL

Combined laser therapy: An Er:YAG laser (160 mj/pulse, 10 Hz) (AT Fidelis Fotona, Ljubljana, Slovenia) with water irrigation was first used to remove subgingival calculus and infected cementum.The Er:YAG laser beam was delivered into the periodontal pockets using a chisel-shaped quartz tip in contact mode under water irrigation, from a coronal to an apical direction with the tip inclined at 10o to 15o to the root surfaces. After Er:YAG laser application, Nd:YAG laser treatment (AT Fidelis Fotona, Ljubljana, Slovenia) was performed at an energy level of 100 mJ/pulse, and 20 Hz for removing pocket epithelium and detoxification purpose. Irradiation was accomplished with a 320 μm fiber optic delivery system. The fiber was inserted into the periodontal pocket base in parallel alignment with the root surface, and the fiber was slowly moved from apical to coronal in a sweeping motion during the laser light emission.

Device: Er-YAG+Nd-YAG lasers

Interventions

Also known as: Hu-Friedy, Gracey curets No. 1/2, 3/4, 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA
Control Group
Also known as: AT Fidelis Fotona, Ljubljana, Slovenia
Test Group

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients had ≥4 teeth per quadrant with probing depth (PD) of ≥5 mm, clinical attachment level (CAL) of ≥4 mm, and radiographic signs of alveolar bone loss. These individuals also had bleeding on probing (BOP) at \>80% of the proximal sites.

You may not qualify if:

  • Periodontal treatment received for the last 1 year; systemic diseases that could influence the outcome of the therapy, pregnancy, smoking, immunosuppressive chemotherapy; and use of antibiotics and anti-inflammatory drugs for the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Assoc.Prof.Dr. Mehmet Sağlam
Organization
Izmir Katip Celebi University, Dentistry Faculty

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: split-mouth
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Department of Periodontology, Faculty of Dentistry, Izmir Katip Celebi University

Study Record Dates

First Submitted

July 25, 2016

First Posted

August 2, 2016

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

April 1, 2016

Last Updated

November 7, 2017

Results First Posted

November 7, 2017

Record last verified: 2017-10