Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.

NCT02487186 | Completed Phase 4 DMC

• 1 other identifier: 012/2009
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical study is to asses the effect of ultrasonic periodontal debridement associated to locally delivered doxycycline (20%) by PLGA microspheres on chronic generalized periodontitis treatment.

Conditions

Periodontal Disease

Keywords

Chronic periodontitis; Local doxycycline; Ultrasonic debridement; PLGA microspheres; Microbiologic assessment

Outcome Measures

Primary Outcomes (1)

• Probing depht (PD)

  Probing depth (PD) will be measured at six sites per tooth by a PCP-15 periodontal Probe (Hu-Friedy - Chicago, IL, USA); This measure will be performed with the use of a plastic stent, presenting edges for the positioning of the stent probe.

  6 months

Secondary Outcomes (1)

• Clinical attachment level (CAL)

  6 months

Study Arms (2)

Test group: DB+DOX

ACTIVE COMPARATOR

Test group: DB (full mouth debridment) +DOX (doxicicline) - 45 minutes of full-mouth debridement + subgingival application of PLGA microspheres loading doxycycline 10%.

Drug: Doxicicline; Procedure: Full-mouth debridment

Control group: DB alone

ACTIVE COMPARATOR

Control group: DB alone (Full-mouth debridment) Intervention: 45 minutes of full-mouth debridement + subgingival application of void PLGA microspheres.

Procedure: Full-mouth debridment

Interventions

Doxicicline DRUG

Association of doxycycline (DOX) encapsulated in PLGA microspheres to ultrasonic debridment for the treatment of patients with chronic generalized periodontitis.

Also known as: PLGA microspheres

Test group: DB+DOX

Full-mouth debridment PROCEDURE

The patients will be treated by a single-session of periodontal debridement during 45 minutes, using an ultrasonic instrument (Cavitron, Dentsply, Rio de Janeiro, Brazil), under irrigation with sterile saline solution 20. After the debridement, local administration of microspheres loading doxycycline (DOX) (test) or empty microspheres (control) was performed.

Control group: DB alone; Test group: DB+DOX

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chronic generalized periodontitis (AAP,1999);
• At least 7 sites with probing depths \>5mm, and 2 sites with probing depth \>7mm;
• At least 20 teeth present;
• Systemically healthy.

You may not qualify if:

• Had received periodontal care 6 months prior to the study;
• Had taken medications known to interfere with periodontal health and healing 6 months prior to the study;
• Pregnants or lactants;
• Smokers;
• Sensitive to doxycycline.

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Piracicaba Dental School, State University of Campinas

Piracicaba, São Paulo, 13414-903, Brazil

Location

MeSH Terms

Conditions

Periodontal Diseases; Chronic Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Enilson A Sallum, PhD

  University of Campinas, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, department of Periodontics, Piracicaba Dental School, State University of Campinas (UNICAMP), Piracicaba, São Paulo, Brazil

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: July 1, 2015
• Study Start: March 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: March 31, 2016

Record last verified: 2015-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)