Benefit of adjunctive systemic postsurgical doxycycline in regenerative periodontal surgery - Effect of postsurgical systemic doxycycline after regenerative periodontal therapy. A randomized pla

• Conditions: 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: 8.1Level: LLTClassification code 10034539Term: Periodontitis

• Registration Number: EUCTR2006-001367-36-DE
• Lead Sponsor: Prof. Dr. Peter Eickholz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-29
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

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 - 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified