NCT03142776

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 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

March 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
Last Updated

May 5, 2017

Status Verified

March 1, 2017

Enrollment Period

1.4 years

First QC Date

May 2, 2017

Last Update Submit

May 4, 2017

Conditions

Aggressive Periodontitis, Generalized

Keywords

clarithromycinphotodynamic therapyAntimicrobial therapyPeriodontal pocket

Outcome Measures

Primary Outcomes (1)

  • Clinical attachment level

    distance from bottom of pocket to the cement-enamel junction

    6 months

Secondary Outcomes (1)

  • Probing depth

    6 months

Study Arms (4)

Periodontal debridement

PLACEBO COMPARATOR

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

Procedure: periodontal debridement

Periodontal debridement + CLM

ACTIVE COMPARATOR

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

Procedure: periodontal debridementDrug: systemic clarithromycin

Periodontal debridement + PDT

ACTIVE COMPARATOR

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).

Procedure: periodontal debridementProcedure: photodynamic therapy

Periodontal debridement + CLM + PDT

ACTIVE COMPARATOR

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

Procedure: periodontal debridementProcedure: photodynamic therapyDrug: systemic clarithromycin

Interventions

periodontal debridementPROCEDURE
Also known as: Ultrassonic periodontal debridement
Periodontal debridementPeriodontal debridement + CLMPeriodontal debridement + CLM + PDTPeriodontal debridement + PDT
photodynamic therapyPROCEDURE
Also known as: antimicrobial photodynamic therapy
Periodontal debridement + CLM + PDTPeriodontal debridement + PDT
systemic clarithromycinDRUG
Also known as: antibiotic
Periodontal debridement + CLMPeriodontal debridement + CLM + PDT

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 24493231BACKGROUND

MeSH Terms

Conditions

Aggressive PeriodontitisPeriodontal Pocket

Interventions

Periodontal DebridementPhotochemotherapyAnti-Bacterial Agents

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental ProphylaxisPeriodonticsDentistryCombined Modality TherapyTherapeuticsDrug TherapyPhototherapyAnti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Mauro P Santamaria, DDS, PhD

    UPECLIN HC FM Botucatu Unesp

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Adjunct professor

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 5, 2017

Study Start

March 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

May 5, 2017

Record last verified: 2017-03