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Effect of Postsurgical Systemic Doxycycline After Regenerative Periodontal Therapy (GTRDOXY)

This study has been terminated.
(shelf life of investigational drug ran out before 90 patients could be included)
Sponsor:
Collaborators:
University of Heidelberg
Dr. August Wolff GmbH & Co. KG Arzneimittel
Gaba International AG
Information provided by (Responsible Party):
Peter Eickholz, Johann Wolfgang Goethe University
ClinicalTrials.gov Identifier:
NCT01030666
First received: December 10, 2009
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Periodontitis
 Drug: Doxycycline
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Postsurgical Systemic Doxycycline After Regenerative Periodontal Therapy. A Randomized Placebo-controlled Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Goethe University:

Primary Outcome Measures:
  • Vertical Clinical Attachment (PAL-V) Gain 6 Months After Surgery [ Time Frame: Baseline to 6 months after surgery ] [ Designated as safety issue: No ]
    Difference of PAL-V measurement at baseline and 6 months. PAL-V were measured to the nearest 0.5 mm using a straight manual periodontal probe (PCPUNC 15, Hu Friedy, Chicago, IL, USA). As reference for the PAL-V measurements, the cemento-enamel junction (CEJ) was used. If the CEJ is destroyed by a restoration (filling, crown) the margin of this restoration served as reference.


Secondary Outcome Measures:
  • Radiographic Bony Fill 12 Months After Surgery (Reduction of Distance Cemento-enamel Junction [CEJ] to Bony Defect [BD]) [ Time Frame: Baseline to 12 months after surgery ] [ Designated as safety issue: No ]
    If the CEJ was destroyed by the restorative treatment the margin of the restoration was taken as landmark. BD is defined as most coronal point where the periodontal ligament space shows a continuous width. If no periodontal ligament space could be identified, the point where the projection of the alveolar crest (AC) crossed the root surface was taken as a landmark. If both structures could be identified at one defect, the point defined by the periodontal ligament was used as BD and the crossing of the silhouette of the alveolar crest with the root surface was defined as AC. If several bony contours could be identified, the most apical one that crossed the root was defined as the BD and the most coronal one as AC.


Enrollment: 61
Study Start Date: April 2007
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: doxycycline
The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects
 Drug: Doxycycline
The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects.
Other Name: Doxy-Wolff 200
Placebo Comparator: placebo
The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect
 Drug: Placebo
The patients of the doxycycline group will take 200 mg placebo once a day for 7 days after regenerative therapy of an infrabony defects.
Other Name: n.a.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030666

Locations
Germany
Dept. of Periodontology, Center of Dental, Oral, and Maxillofacial Medicine, Johann Wolfgang Goethe-University
Frankfurt am Main, Germany, 60590
Section of Periodontology, University Hospital Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Peter Eickholz
University of Heidelberg
Dr. August Wolff GmbH & Co. KG Arzneimittel
Gaba International AG
Investigators
Principal Investigator: Peter Eickholz, Prof Dr Dept. of Periodontology, Center for Dental, Oral, and Maxillofacial Medicine, Johann Wolfgang Goethe-University
  More Information

No publications provided

Responsible Party: Peter Eickholz, Prof. Dr. med. dent., Johann Wolfgang Goethe University
ClinicalTrials.gov Identifier: NCT01030666     History of Changes
Other Study ID Numbers: DoxP-01/2006
Study First Received: December 10, 2009
Results First Received: September 22, 2012
Last Updated: November 27, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Goethe University:
periodontal regeneration
radiographic bone fill
infrabony defects
randomized placebo-controlled clinical trial
guided tissue regeneration, periodontal

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 16, 2013