Periodontitis Clinical Trial
— ABPARO-StudieOfficial title:
Adjunctive Antimicrobial Therapy of Periodontitis: Long-Term Effects on Disease Progression and Oral Microbiological Colonization
The purpose of this study is to determine the size of the benefit of an adjunctive empiric antibiotic therapy compared to standard mechanical debridement and oral hygiene instructions in a representative sample of German periodontitis patients.
Status | Completed |
Enrollment | 540 |
Est. completion date | January 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Medizinische Fakultät der Humboldt Universität Berlin (Charité) | Berlin | |
Germany | Universitätsklinikum Carl Gustav Carus, Zentrum für Zahn-, Mund- und Kieferheilkunde | Dresden | |
Germany | Zentrum der Zahn-, Mund- und Kieferheilkunde (Carolinum), Poliklinik für Parodontologie | Frankfurt | |
Germany | Justus-Liebig-Universität Gießen, Poliklinik für Parodontologie | Giessen | |
Germany | Universitätsklinikum Greifswald, Poliklinik für Zahnerhaltung, Parodontologie und Kinderzahnheilkunde | Greifswald | |
Germany | Universitätsklinikum Heidelberg, Poliklinik für Zahnerhaltungskunde, Sektion Parodontologie | Heidelberg | |
Germany | University Hospital Muenster, Dept. of Periodontology | Muenster | |
Germany | Universität Würzburg, Poliklinik für Parodontologie | Würzburg |
Lead Sponsor | Collaborator |
---|---|
University Hospital Muenster |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of sites showing attachment loss = 1.3 mm over a 27.5-months period | 27.5-months period (six measurements) | No | |
Secondary | Subjective perception of treatment outcome, attachment gain, pocket probing depths, bleeding on probing, and full mouth plaque score. Microbial colonization dynamic. | over a 27.5-months period | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04712630 -
Non-Incised Papillae Surgical Approach (NIPSA) With and Without Graft
|
N/A | |
Completed |
NCT06127069 -
Treatment of Residual Pockets in Periodontal Patients Using an Oscillating Chitosan Device
|
N/A | |
Completed |
NCT04964167 -
Indocyanine-green Mediated Photosensitizer VS Aloe Vera Gel: Adjunct Therapy to Scaling and Root Planing in Patients With Chronic Periodontitis
|
Phase 4 | |
Completed |
NCT05906797 -
Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis.
|
N/A | |
Recruiting |
NCT03997552 -
NIPSA Versus Marginal Approach by Palatal Incision and MIST in Periodontal Regeneration
|
N/A | |
Completed |
NCT05530252 -
Effects of AMP Application After Non-surgical Periodontal Therapy on Treatment of Periodontitis
|
Phase 4 | |
Completed |
NCT04881357 -
Antiplaque/Antigingivitis Effect of Lacer Oros Integral
|
N/A | |
Recruiting |
NCT03790605 -
A Clinical Trial to Study the Effect of a Drug, Curcumin in Patients With Periodontitis
|
Phase 3 | |
Enrolling by invitation |
NCT04971174 -
Outcomes of Periodontal Regenerative Treatment
|
||
Not yet recruiting |
NCT05568290 -
Interleukin-38 Levels in Individuals With Periodontitis
|
||
Completed |
NCT04383561 -
Relationship Between LRG and Periodontal Disease
|
N/A | |
Recruiting |
NCT03997578 -
Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Emdogain for Periodontal Defects
|
N/A | |
Completed |
NCT03901066 -
Smoking Dependence and Periodontitis
|
||
Enrolling by invitation |
NCT04956211 -
Periodontal Treatment and Ischemic Stroke
|
N/A | |
Recruiting |
NCT05971706 -
Ozone Application in Periodontal Treatment
|
N/A | |
Recruiting |
NCT06099574 -
A Study on the Oral Health Status of Pregnant Women With Gestational Diabetes and Its Correlation With Oral Flora
|
||
Completed |
NCT04402996 -
Meteorin-like Levels in Individuals With Periodontitis
|
||
Active, not recruiting |
NCT05311657 -
Oral Health and Severe COPD
|
||
Not yet recruiting |
NCT06453278 -
(DDS) in India: a Screening Tool to Identify Prediabetes and Undiagnosed Type 2 Diabetes in Dental Settings
|
||
Not yet recruiting |
NCT05643287 -
The Effect of Time on the Outcome of Periodontal Treatment.
|
N/A |