Effect of Postsurgical Systemic Doxycycline After Regenerative Periodontal Therapy (GTRDOXY)
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.
|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|
- 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.
- 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.
|Study Start Date:||April 2007|
|Study Completion Date:||February 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
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 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
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01030666
|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|
|Principal Investigator:||Peter Eickholz, Prof Dr||Dept. of Periodontology, Center for Dental, Oral, and Maxillofacial Medicine, Johann Wolfgang Goethe-University|