NCT03387371

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2018

Completed
Last Updated

January 2, 2018

Status Verified

November 1, 2017

Enrollment Period

1.5 years

First QC Date

November 7, 2017

Last Update Submit

December 29, 2017

Conditions

Chronic Periodontitis

Keywords

chronic periodontitis, laser

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (4)

  • Bleeding On Probing 3

    3. month

  • Bleeding On Probing 6

    6. month

  • Plak Index 3

    3. month

  • Plak Index 6

    6. month

Study Arms (2)

Ultrasonics & Gracey Curettes

ACTIVE COMPARATOR

Scaling and root planning is done with ultrasonics and gracey curettes in 24 hours with two visits.

Device: UltrasonicsDevice: Gracey Curettes

Ultrasonics & Gracey Curettes & Laser

EXPERIMENTAL

Scaling and root planning is done with ultrasonics, gracey curettes and Er:YAG laser in 24 hours with two visits.

Device: Gracey CurettesDevice: Er:YAG Laser

Interventions

UltrasonicsDEVICE

ultrasonic scalers

Ultrasonics & Gracey Curettes
Gracey CurettesDEVICE

Spesific gracey curettes

Ultrasonics & Gracey CurettesUltrasonics & Gracey Curettes & Laser
Er:YAG LaserDEVICE

2940 nm wavelenght Er:YAG laser

Ultrasonics & Gracey Curettes & Laser

Eligibility Criteria

Age28 Years - 58 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31050949DERIVED

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

UltrasonographyLasers, Solid-State

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisLasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2017

First Posted

January 2, 2018

Study Start

July 18, 2016

Primary Completion

January 20, 2018

Study Completion

January 20, 2018

Last Updated

January 2, 2018

Record last verified: 2017-11