E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034539 |
E.1.2 | Term | Periodontitis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
Assessment of immediate postsurgical wound healing after regenerative periodontal surgery with or without adjunctive systemic doxycycline. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 </= 30% [O’Leary et al. 1972]) - interproximal angular defects on single-rooted teeth or multi-rooted teeth without furcation involvement, radiographic infrabony component >/= 4 mm, vertical clinical attachment loss (CAL-V) > 6 mm and PPD >/= 6 mm - Only women in childbearing age (< 45 years) who provide contraception from screening to U2- informed written consent
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial will be finished when the last patient that was treated has had the 24 months re examination. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |