Nonsurgical Periodontal Treatment Associated or Not With Systemic Antibiotics and Photodynamic Therapy

NCT ID: NCT03142776

Last Updated: 2017-05-05

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-08-31

Brief Summary

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To assess the local effect of the antimicrobial therapy using clarithromycin association with photodynamic therapy (PDT) in the treatment of generalized aggressive periodontitis (GAgP).

Detailed Description

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The aim of the present study was to evaluate the local effect of the antimicrobial therapy using clarithromycin (CLM) association with photodynamic therapy (PDT) in the treatment of generalized aggressive periodontitis (GAgP). Sixty periodontal pockets were select and randomly assigned into four groups: Periodontal Debridement (PD) (n=15): periodontal pockets that received periodontal debridement (PD) with placebo; PD+CLM (n=15): periodontal pockets that received periodontal debridement associated with clarithromycin; PD+PDT (n=15): periodontal pockets that received periodontal debridement associated with photodynamic therapy; PD+CLM+PDT (n=15): periodontal pockets that received periodontal debridement associated with clarithromycin and photodynamic therapy. Probing depth (PD),gain in clinical attachment level (CAL) and bleeding on probing (BOP) were evaluated at baseline, 3 and 6 months post- operatively.

Conditions

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Aggressive Periodontitis, Generalized

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Periodontal debridement

Periodontal pockets that received periodontal debridement associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).

Group Type PLACEBO_COMPARATOR

periodontal debridement

Intervention Type PROCEDURE

Periodontal debridement + CLM

Periodontal pockets that received periodontal debridement associated with systemic clarithromycin (500 mg - 12/12 hours) for 3 days.

Group Type ACTIVE_COMPARATOR

periodontal debridement

Intervention Type PROCEDURE

systemic clarithromycin

Intervention Type DRUG

Periodontal debridement + PDT

Periodontal pockets that received periodontal debridement associated with placebo (members took with placebo 500 mg b.i.d. for 3 days) and a single application of PDT (Photodynamic Therapy).

Group Type ACTIVE_COMPARATOR

periodontal debridement

Intervention Type PROCEDURE

photodynamic therapy

Intervention Type PROCEDURE

Periodontal debridement + CLM + PDT

Periodontal pockets that received periodontal debridement associated with systemic clarithromycin (500 mg - 12/12 hours for 3 days) and single application of PDT.

Group Type ACTIVE_COMPARATOR

periodontal debridement

Intervention Type PROCEDURE

photodynamic therapy

Intervention Type PROCEDURE

systemic clarithromycin

Intervention Type DRUG

Interventions

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periodontal debridement

Intervention Type PROCEDURE

photodynamic therapy

Intervention Type PROCEDURE

systemic clarithromycin

Intervention Type DRUG

Other Intervention Names

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Ultrassonic periodontal debridement antimicrobial photodynamic therapy antibiotic

Eligibility Criteria

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Inclusion Criteria

* diagnosis of GagP
* presence of ≥20 teeth
* \<35 years of age
* periodontal pockets with probing depth (PD) and Clinical Attachment Level (CAL) ≥ 5mm with concomitant bleeding on probing (BOP) in single-rooted teeth from different quadrants - agree to participate in the study and sign a written consent.

Exclusion Criteria

* pregnant or lactating
* suffering from any other systemic disease (e.g. cardiovascular, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease
* received antimicrobials in the previous 6 months
* taking long-term anti-inflammatory drugs
* received a course of periodontal treatment within the last 12 months
* smoked
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role lead

Responsible Party

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Mauro Pedrine Santamaria

PhD, Adjunct professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mauro P Santamaria, DDS, PhD

Role: STUDY_DIRECTOR

UPECLIN HC FM Botucatu Unesp

References

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Arweiler NB, Pietruska M, Pietruski J, Skurska A, Dolinska E, Heumann C, Auschill TM, Sculean A. Six-month results following treatment of aggressive periodontitis with antimicrobial photodynamic therapy or amoxicillin and metronidazole. Clin Oral Investig. 2014 Dec;18(9):2129-35. doi: 10.1007/s00784-014-1193-6. Epub 2014 Feb 4.

Reference Type BACKGROUND
PMID: 24493231 (View on PubMed)

Other Identifiers

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CLMPDT

Identifier Type: -

Identifier Source: org_study_id

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