Adjunctive Antimicrobial Therapy of Periodontitis: Long-Term Effects on Disease Progression and Oral Microbiological Colonization

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00707369
• Date of registration: 24/06/2008
• Primary sponsor: University Hospital Muenster
• Public title: Adjunctive Antimicrobial Therapy of Periodontitis: Long-Term Effects on Disease Progression and Oral Microbiological Colonization ABPARO-Studie
• Scientific title: Adjunctive Antimicrobial Therapy of Periodontitis: Long-Term Effects on Disease Progression and Oral Microbiological Colonization
• Date of first enrolment: October 2008
• Target sample size: 500
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00707369
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Germany

Contacts

• Name: Benjamin - Ehmke, PhD
• Affiliation: University Hospital Muenster, Dept. of Periodontology

Key inclusion & exclusion criteria

Inclusion Criteria:

- periodontal screening index (PSI) of IV in at least one sextant;

- range from 18 to 75 years of age;

- clinical and radiographic signs of moderate (clinical attachment loss [CAL] of 3 to 4
mm) to severe (CAL 5 mm or more) chronic or aggressive periodontitis;

- at least 10 natural teeth in situ;

- pocket probing depths (PPDs) of = 6 mm at a minimum of four teeth;

- willingness to participate and to be available at all times required for
participation;

- willingness to abstain from using antimicrobial mouth-rinses during the study except
for those explicitly prescribed;

- informed consent signed by the patient;

- sufficient knowledge of German language.

Exclusion Criteria:

- if they (or parents or siblings) show confirmed or assumed allergies or
hyper-sensitive skin reactions against amoxicillin (or other penicillins or other
ingredients of Amoxicillin-ratiopharm® 500mg as listed in the "summary of product
characteristics, Version Juli 2005"), metronidazole (or other 5-nitroimidazoles and
ingredients of Flagyl® 400mg as listed in the "summary of product characteristics,
Version Juli 2007"), systemic diseases or conditions as listed in the above mentioned
"summary of product characteristics", or show confirmed lactose intolerance;

- have Down's syndrome;

- known AIDS/HIV;

- regularly take systemic medication affecting the periodontal conditions, e.g.
phenytoin, nifedipine, and/or steroid drugs;

- professional periodontal therapy during 6 months prior to baseline;

- require antibiotic treatment for dental appointments;

- are undergoing or require extensive dental or orthodontic treatment;

- are pregnant or breastfeeding;

- have rampant caries;

- any oral or extraoral piercing in or around the oral cavity with ornaments or
accessory jewelry;

- are dental students or dental professionals;

- have participated in a clinical dental trial in the six months preceding the study;

- cognitive deficits.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Periodontitis

Intervention(s)

Drug: Amoxicillin and Metronidazole

Drug: Placebo

Primary Outcome(s)

Percentage of sites showing attachment loss = 1.3 mm over a 27.5-months period [Time Frame: 27.5-months period (six measurements)]

Secondary Outcome(s)

Subjective perception of treatment outcome, attachment gain, pocket probing depths, bleeding on probing, and full mouth plaque score. Microbial colonization dynamic. [Time Frame: over a 27.5-months period]

Secondary ID(s)

DFG grant: EH 365/1-1

EH 365/1-1

ISRCTN : 64254080

Source(s) of Monetary Support

Please refer to primary and secondary sponsors