Low-level Laser Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics

NCT ID: NCT02817152

Last Updated: 2016-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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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. Twenty poorly-controlled type 2 diabetic patients with moderate to severe generalized chronic periodontitis were selected. Two periodontal pockets with Probing Depth (PD) and Clinical Attachment Level (CAL) ≥ 5mm received ultrasonic periodontal debridement (UPD) only (control group) or UPD with LLLT (test group). Clinical measures, such as PD, CAL, Gingival Recession (GR), Bleeding on Probing (BoP), and Plaque Index (PI), were collected and compared at baseline, 30, 90, and 180 days. The adjunct application of LLLT to UPD had no additional benefits for PD reduction and CAL gain, meaning that both investigated therapies were efficient for the treatment of chronic periodontitis in type 2 diabetics. Nevertheless, additional LLLT application showed better results for GR then UPD only.

Conditions

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Chronic Periodontitis Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Periodontal ultrasonic debridement

Periodontal pockets received ultrasonic periodontal debridement intervention.

Group Type SHAM_COMPARATOR

Periodontal ultrasonic debridement

Intervention Type PROCEDURE

Periodontal pockets received periodontal ultrasonic debridement intervention.

Low-level laser therapy

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

Group Type ACTIVE_COMPARATOR

Periodontal ultrasonic debridement

Intervention Type PROCEDURE

Periodontal pockets received periodontal ultrasonic debridement intervention.

Debridement plus low-level laser therapy

Intervention Type DEVICE

Ultrasonic debridement plus low-level laser therapy.

Interventions

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Periodontal ultrasonic debridement

Periodontal pockets received periodontal ultrasonic debridement intervention.

Intervention Type PROCEDURE

Debridement plus low-level laser therapy

Ultrasonic debridement plus low-level laser therapy.

Intervention Type DEVICE

Other Intervention Names

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periodontal debridement ultrasonic debridement low-level light therapy low-power laser therapy low-intensity laser therapy

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role lead

Responsible Party

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Nídia Cristina Castro dos Santos

DDS, MS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mauro P Santamaria, DDS, MS, PhD

Role: STUDY_DIRECTOR

UPECLIN HC FM Botucatu Unesp

References

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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.

Reference Type RESULT
PMID: 20932157 (View on PubMed)

Other Identifiers

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NCSlaser

Identifier Type: -

Identifier Source: org_study_id

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