Effect of Postsurgical Systemic Doxycycline After Regenerative Periodontal Therapy
Condition: Periodontitis
MeSH terms: Periodontitis
Intervention: Doxycycline; Placebo; modified/simplified papilla preservation flap; scaling; Prefgel/Emdogain; 0.12% chlorhexidine gluconate solution; Ibuprofen 400 mg (if necessary); 1% chlorhexidine gluconate gel (if necessary)
Intervention description: The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects.; The patients of the doxycycline group will take 200 mg placebo once a day for 7 days after regenerative therapy of an infrabony defects.; Following an intra-crevicular incision a mucoperiosteal flap was reflected to a height of 5 mm exposing the bony margin of the defect and allowing complete visualization of the infrabony lesion. The flap was designed according to the modified or simplified papilla preservation technique to obtain primary closure of the wound and the membrane respectively. The flap was extended at least one tooth mesially and distally of the defect side. After complete removal of inflammatory granulation tissue, the root surfaces were thoroughly scaled and root planed.; When using EMD the root surfaces facing the infrabony defect were conditioned with EDTA (prefgel; Institut Straumann AG, Basel, Switzerland) for 2 min. first. Then the EDTA was washed out with plenty of saline. After drying the surfaces EMD was applied starting at the bottom of the defect and proceeding coronally.; Furthermore, all patients were advised to rinse with a 0.12% chlorhexidine gluconate solution (ParoEx; Butler, Kriftel, Germany) for 2 min. twice daily for 5-7 weeksafter surgery.; 400 mg ibuprofen qd was prescribed for patient's comfort if necessary.; If soft tissue dehiscence was noted the patient was advised to use a 1% chlorhexidine gluconate gel (Chlorhexamed 1% Gel; GlaxoSmithKline, Bühl, Germany) twice daily
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Doxycycline; Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: periodontal regeneration; radiographic bone fill; infrabony defects; randomized placebo-controlled clinical trial; guided tissue regeneration, periodontal

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.
    

Eligibility 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 </= 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

        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