NCT02817152

Brief Summary

The aim of this study was to investigate the local effect of adjunct low-level laser therapy (LLLT) for the treatment of moderate to severe chronic periodontitis in type 2 diabetic patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 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

February 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

1.6 years

First QC Date

June 10, 2016

Last Update Submit

July 8, 2016

Conditions

Chronic PeriodontitisDiabetes Mellitus

Keywords

periodontal treatmentlow-level light therapy

Outcome Measures

Primary Outcomes (1)

  • Probing depth change from baseline to 30, 90, and 180 days through periodontal probing

    baseline, 30 days, 90 days, 180 days

Secondary Outcomes (4)

  • Clinical attachment level change from baseline to 30, 90, and 180 days through periodontal probing

    baseline, 30 days, 90 days, 180 days

  • Gingival recession change from baseline to 30, 90, and 180 days through periodontal probing

    baseline, 30 days, 90 days, 180 days

  • Bleeding on probing change from baseline to 30, 90, and 180 days through periodontal probing

    baseline, 30 days, 90 days, 180 days

  • Plaque index change from baseline to 30, 90, and 180 days through periodontal probing

    baseline, 30 days, 90 days, 180 days

Other Outcomes (1)

  • Glycated hemoglobin

    Baseline, 180 days

Study Arms (2)

Periodontal ultrasonic debridement

SHAM COMPARATOR

Periodontal pockets received ultrasonic periodontal debridement intervention.

Procedure: Periodontal ultrasonic debridement

Low-level laser therapy

ACTIVE COMPARATOR

Periodontal pockets received ultrasonic periodontal debridement plus low-level laser therapy intervention.

Procedure: Periodontal ultrasonic debridementDevice: Debridement plus low-level laser therapy

Interventions

Periodontal ultrasonic debridementPROCEDURE

Periodontal pockets received periodontal ultrasonic debridement intervention.

Also known as: periodontal debridement, ultrasonic debridement
Low-level laser therapyPeriodontal ultrasonic debridement
Debridement plus low-level laser therapyDEVICE

Ultrasonic debridement plus low-level laser therapy.

Also known as: low-level light therapy, low-power laser therapy, low-intensity laser therapy
Low-level laser therapy

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥ 35; diagnosis of type 2 diabetes for ≥ 5 years; diabetes treatment with oral hypoglycemic agents or insulin supplementation and diet; glycated hemoglobin (HbA1c) levels from 6.5% to 11%; at least 15 teeth (excluding third molars and teeth indicated for extraction); and moderate to severe generalized chronic periodontitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Aykol G, Baser U, Maden I, Kazak Z, Onan U, Tanrikulu-Kucuk S, Ademoglu E, Issever H, Yalcin F. The effect of low-level laser therapy as an adjunct to non-surgical periodontal treatment. J Periodontol. 2011 Mar;82(3):481-8. doi: 10.1902/jop.2010.100195. Epub 2010 Oct 8.

    PMID: 20932157RESULT

MeSH Terms

Conditions

Chronic PeriodontitisDiabetes Mellitus

Interventions

Periodontal DebridementDebridementLow-Level Light Therapy

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Dental ProphylaxisPeriodonticsDentistrySurgical Procedures, OperativeLaser TherapyTherapeuticsPhototherapy

Study Officials

  • Mauro P Santamaria, DDS, MS, PhD

    UPECLIN HC FM Botucatu Unesp

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, MS

Study Record Dates

First Submitted

June 10, 2016

First Posted

June 29, 2016

Study Start

February 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

July 12, 2016

Record last verified: 2016-07