Periodontitis is an opportunistic infectious disease that destroys the periodontal attachment and bone. Bacterial plaque (biofilm) on the teeth adjacent to the gingiva is the necessary cause gingival inflammation (gingivitis). To proceed from gingivitis to periodontitis further intrinsic and/or extrinsic (e.g. smoking) factores are required. In many cases periodontal destruction develops at different speed at different teeth. This generates so called infrabony defects. MedDRA version: 8.1 Level
Conditions
Interventions
Trade Name: Doxy-Wolff 200 mg
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Doxycycline
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutica
Sponsors
Prof. Dr. Peter Eickholz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - adult patients (at least 18 years of age) with moderate to severe periodontal disease (chronic and aggressive periodontitis) to be recruited from the Department of Periodontology, Centre for Dental, Oral, and Maxillofacial Medicine, Hospital of the Johann Wolfgang Goethe-University Frankfurt/Main and from the Section of Periodontology, Department of Conservative Dentistry, Clinic for Oral, Dental, and Maxillofacial Diseases, University Hospital Heidelberg - completed initial periodontal treatment consisting of oral hygiene instruction, scaling and root planing under local anesthesia according the concept of full-mouth disinfection and re evaluation of the tissue response and the patient's plaque control 3 months later. Sites with infrabony defects and persisting pockets (PD > 5 mm and bleeding on probing, BOP) that occur at re evaluation or supportive periodontal treatment (SPT) are subjected to surgical therapy. - at least one radiographically detectable infrabony lesion (Goldmann & Cohen 1957, Weinberg & Estrow 2000) - good physical health and with effective individual plaque control (Full-mouth-plaque score PCR /= 4 mm, vertical clinical attachment loss (CAL-V) > 6 mm and PPD >/= 6 mm - Only women in childbearing age (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - known allergies to tetracyclines or any components of the active drug or placebo - severe liver dysfunction - local or systemic antibiotic treatment during the last 3 months before surgery - ineffective individual plaque control (PCR > 30%) - liver and/or kidney dysfunction - medication with barbiturate, carbamazepin, diphenyhydantoine, sulfonyl-urea, methoxyfluran, ciclosporin A, theophylline, isotretionin - chronic alcohol abuse - anticoagulative therapy - need for antibiotic endocarditis prophylaxis - pregnancy - lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Hypothesis: Adjunctive systemic doxycycline rendered after regenerative periodontal surgery reduces postsurgical complications (e.g. membrane exposure and flap dehiscence) and improves clinical results. Assessment of clinical parameters after regenerative periodontal surgery with or without adjunctive systemic doxycycline. ;Secondary Objective: Assessment of immediate postsurgical wound healing after regenerative periodontal surgery with or without adjunctive systemic doxycycline.;Primary end point(s): difference between test (doxycycline) and control (placebo) regarding 1) Clinical parameters: clinical vertical attachment (CAL-V) gain 6 months after therapy 2) Radiographic parameters: bony fill 12 months after therapy 3) immediate postsurgical healing | — |
Countries
Germany
Outcome results
None listed