Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.

• Register: ClinicalTrials.gov
• Last refreshed on: 11 April 2016
• Main ID: NCT02487186
• Date of registration: 26/06/2015
• Prospective Registration: No
• Primary sponsor: University of Campinas, Brazil
• Public title: Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.
• Scientific title: Evaluation of PLGA Microspheres Loaded With Doxycycline Associated to Periodontal Debridement in the Treatment of Chronic Advanced Periodontitis.
• Date of first enrolment: March 2010
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02487186
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Brazil

Contacts

• Name: Enilson A Sallum, PhD
• Affiliation: University of Campinas, Brazil

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.



Age minimum: 35 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Periodontal Disease

Intervention(s)

Procedure: Full-mouth debridment

Drug: Doxicicline

Primary Outcome(s)

Probing depht (PD) [Time Frame: 6 months]

Secondary Outcome(s)

Clinical attachment level (CAL) [Time Frame: 6 months]

Secondary ID(s)

012/2009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors