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.

Conditions

• Periodontitis

Interventions

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.

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.

PROCEDURE

modified/simplified papilla preservation flap; scaling

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.

BIOLOGICAL

Prefgel/Emdogain

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.

DRUG

0.12% chlorhexidine gluconate solution

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.

DRUG

Ibuprofen 400 mg (if necessary)

400 mg ibuprofen qd was prescribed for patient's comfort if necessary.

DRUG

1% chlorhexidine gluconate gel (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

Sponsors & Collaborators

• Heidelberg University

  collaborator OTHER

• Dr. August Wolff GmbH & Co. KG Arzneimittel

  collaborator INDUSTRY

• Gaba International AG

  collaborator INDUSTRY

• Peter Eickholz

  lead OTHER

Principal Investigators

• Peter Eickholz, Prof Dr · Dept. of Periodontology, Center for Dental, Oral, and Maxillofacial Medicine, Johann Wolfgang Goethe-University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-04-30

Primary Completion

2011-01-31

Completion

2011-02-28

Countries

• Germany

Study Locations