Effect of Postsurgical Systemic Doxycycline After Regenerative Periodontal Therapy
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.
Timeline
- Start
- 2007-04
- Primary completion
- 2011-01
- Completion
- 2011-02
Outcome
Missed primary endpoint
Stopped: “shelf life of investigational drug ran out before 90 patients could be included”
paper failed to result in better PPD reduction and PAL-V gain compared with PLAC PMID 22385260 ↗
Publications
- Results Rollke L, Schacher B, Wohlfeil M, Kim TS, Kaltschmitt J, Krieger J, Krigar DM, Reitmeir P, Eickholz P. Regenerative therapy of infrabony defects with or without systemic doxycycline. A randomized placebo-controlled trial. J Clin Periodontol. 2012 May;39(5):448-56. doi: 10.1111/j.1600-051X.2012.01861.x. Epub 2012 Mar 4.
- Results Eickholz P, Rollke L, Schacher B, Wohlfeil M, Dannewitz B, Kaltschmitt J, Krieger JK, Krigar DM, Reitmeir P, Kim TS. Enamel matrix derivative in propylene glycol alginate for treatment of infrabony defects with or without systemic doxycycline: 12- and 24-month results. J Periodontol. 2014 May;85(5):669-75. doi: 10.1902/jop.2013.130290. Epub 2013 Sep 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxycycline | Small molecule | 200 mg | Oral |
| Background | Chlorhexidine gluconate | Other / unclassified | 0.12 % | — |
| Background | Chlorhexidine gluconate | Other / unclassified | 1 % | — |
| Background | Emdogain | Other / unclassified | — | — |
| Background | Ibuprofen | Small molecule | 400 mg | — |
| Background | prefgel | Unknown | — | — |