Effect of Postsurgical Systemic Doxycycline After Regenerative Periodontal Therapy

• Status: Terminated
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Study Hypothesis: The administration of 200 mg doxycycline once a day for 7 days after regenerative periodontal therapy of infrabony defects improves the results of therapy (clinical vertical attachment gains [CAL-V], bony fill) and reduces postoperative flap dehiscence and defect exposure.

In each of 90 patients one infrabony defect shall be treated by regenerative techniques (guided tissue regeneration [GTR], enamel matrix derivative [EMD]). Prior to , 6, 12, and 24 months after surgery clinical measurements (Plaque Index [PlI], probing depth [PD], vertical clinical attachment level [CAL-V], Gingival Index [GI]) and standardized radiographs are obtained.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peter Eickholz
• Collaborators: Dr. August Wolff GmbH & Co. KG Arzneimittel; Gaba International AG; Heidelberg University
• Treatments: Chlorhexidine; Chlorhexidine gluconate; Doxycycline; Ibuprofen; Pharmaceutical Solutions

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 Dept. of Periodontology, Centre for Dental, Oral, and Maxillofacial Medicine, Hospital of the Johann Wolfgang Goethe-University Frankfurt/Main and from the Section of Periodontology, Dept. 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

• 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

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%)

• kidney dysfunction

• medication with barbiturate, carbamazepin, diphenyhydantoine, sulfonyl-urea, methoxyflurane, ciclosporin A, theophylline, isotretionin

• chronic alcohol abuse

• anticoagulative therapy

• need for antibiotic endocarditis prophylaxis

• pregnancy

• lactation