NCT03034824

Brief Summary

The aim of our study is to determine the interleukin-1βeta (IL-1β), interleukin-8 (IL-8) and tumor necrosis factor-αlfa (Tnf-α) levels in gingival crevicular fluid (GCF) and clinical periodontal parameters following the treatment with Erbium,Chromium:Yttrium-Scandium-Gallium-Garnet (Er,Cr:YSGG) and diode lasers in adjunct to scaling and root planing (SRP) in patients with generalized aggressive periodontitis (GAgP). Twenty-six patients with GAgP (n=26) were enrolled in the study. The study was designed as a "split-mouth" study. In each patient, three quadrants were randomly determined as SRP-control, SRP+Er,Cr:YSGG and SRP+Diode laser. Clinical periodontal measurements were recorded at the baseline and third month after the treatment. Cytokines levels in GCF were determined by enzyme-linked immunosorbent assay (ELISA).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Status
completed

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

January 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

8 months

First QC Date

December 21, 2016

Last Update Submit

February 22, 2017

Conditions

Aggressive Periodontitis

Keywords

diode laserEr,Cr:YSGG laserAggressive PeriodontitisClinical periodontal parametersGingival crevicular fluid cytokines levels

Outcome Measures

Primary Outcomes (5)

  • Periodontal Clinical Indices

    Bleeding on probing

    1 year

  • Periodontal Clinical Indices

    Plaque index

    1 year

  • Periodontal Clinical Indices

    Gingival index

    1 year

  • Periodontal Clinical Indices

    Probing pocket depth

    1 year

  • Periodontal Clinical Indices

    Clinical attachment level

    1 year

Secondary Outcomes (3)

  • Cytokines levels in gingival crevicular fluids

    1 year

  • Cytokines levels in gingival crevicular fluids

    1 year

  • Cytokines levels in gingival crevicular fluids

    1 year

Study Arms (3)

Scaling and root planing (SRP)-Control

EXPERIMENTAL

Only non-surgical initial periodontal treatment (scaling and root planing)

Procedure: Scaling and root planing (SRP)-Control

SRP+940±15 nm diode laser

EXPERIMENTAL

In addition to non-surgical initial periodontal treatment (scaling and root planing), individuals received 940±15 nm Diode laser

Procedure: SRP+940±15 nm diode laser

SRP+Er,Cr:YSGG laser

EXPERIMENTAL

In addition to non-surgical initial periodontal treatment (scaling and root planing), individuals received Er,Cr:YSGG laser

Procedure: SRP+Er,Cr:YSGG laser

Interventions

SRP+940±15 nm diode laserPROCEDURE

In addition to Non-surgical periodontal treatment, the individuals diagnosed with Generalized Aggressive Periodontitis were applied the 940±15 nm diode laser.

SRP+940±15 nm diode laser
SRP+Er,Cr:YSGG laserPROCEDURE

In addition to Non-surgical periodontal treatment, the individuals diagnosed with Generalized Aggressive Periodontitis were applied the Er,Cr:YSGG laser.

SRP+Er,Cr:YSGG laser
Scaling and root planing (SRP)-ControlPROCEDURE

Only Non-surgical periodontal treatment

Scaling and root planing (SRP)-Control

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • No systemic diseases
  • Not used antibiotics or any other medication affecting the immune system in the previous six months
  • Non-smokers
  • Have at least 16 teeth in their mouth
  • Have not received any periodontal treatment in the previous 6 months

You may not qualify if:

  • Under 18 age
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hakki SS, Korkusuz P, Berk G, Dundar N, Saglam M, Bozkurt B, Purali N. Comparison of Er,Cr:YSGG laser and hand instrumentation on the attachment of periodontal ligament fibroblasts to periodontally diseased root surfaces: an in vitro study. J Periodontol. 2010 Aug;81(8):1216-25. doi: 10.1902/jop.2010.090715.

    PMID: 20476883RESULT

MeSH Terms

Conditions

Aggressive Periodontitis

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Ahmet C Talmac, PhD

    Researcher

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Dr. Dt.

Study Record Dates

First Submitted

December 21, 2016

First Posted

January 27, 2017

Study Start

January 1, 2014

Primary Completion

September 1, 2014

Study Completion

August 1, 2015

Last Updated

February 24, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share