Two Multi‐Center Studies Evaluating Locally Delivered Doxycycline Hyclate, Placebo Control, Oral Hygiene, and Scaling and Root Planing in the Treatment of Periodontitis

Background: The clinical efficacy and safety of doxycycline hyclate (8.5% w/w) delivered subgingivally in a biodegradable polymer (DH) was compared to placebo control (VC), oral hygiene (OH), and scaling and root planing (SRP) in 2 multi‐center studies. Methods: Each study entered 411 patients who d...

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Published in:Journal of periodontology (1970) 1999-05, Vol.70 (5), p.490-503
Main Authors: Garrett, Steven, Johnson, Lonnie, Drisko, Connie Hastings, Adams, Donald F., Bandt, Carl, Beiswanger, Bradley, Bogle, Gary, Donly, Kevin, Hallmon, William W., Hancock, E. Brady, Hanes, Philip, Hawley, Charles E., Kiger, Robert, Killoy, William, Mellonig, James T., Polson, Alan, Raab, Frank J., Ryder, Mark, Stoller, Norman H., Wang, Hom‐Lay, Wolinsky, Lawrence E., Evans, Gerald H., Harrold, Charles Q., Arnold, Ralph M., Atack, David F., Fitzgerald, Bryan, Hill, Margaret, Isaacs, Roger L., Nasi, Hisham F., Newell, Donald H., MacNeil, R. Lamont, MacNeill, Simon, Spolsky, Vladimir W., Duke, Susan P., Polson, Anne, Southard, G. Lee
Format: Article
Language:English
Subjects:
Absorbable Implants
Administration, Topical
Adult
Aged
Anti-Bacterial Agents - administration & dosage
Anti-Bacterial Agents - therapeutic use
Biocompatible Materials - chemistry
Dental Scaling
Dentistry
Doxycycline - administration & dosage
Doxycycline - analogs & derivatives
Doxycycline - therapeutic use
Drug delivery systems
Drug Delivery Systems - instrumentation
Follow-Up Studies
Gingival Hemorrhage - drug therapy
Gingival Hemorrhage - therapy
Humans
Middle Aged
multi‐center studies
Oral Hygiene
Periodontal Attachment Loss - drug therapy
Periodontal Attachment Loss - therapy
Periodontal Pocket - drug therapy
Periodontal Pocket - therapy
Periodontitis - drug therapy
Periodontitis - therapy
Placebos
Polyesters - chemistry
Pyrrolidinones - chemistry
Root Planing
Safety
Single-Blind Method
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Summary:Background: The clinical efficacy and safety of doxycycline hyclate (8.5% w/w) delivered subgingivally in a biodegradable polymer (DH) was compared to placebo control (VC), oral hygiene (OH), and scaling and root planing (SRP) in 2 multi‐center studies. Methods: Each study entered 411 patients who demonstrated moderate to severe periodontitis. Patients had 2 or more quadrants each with a minimum of 4 qualifying pockets ≥5 mm that bled on probing. At least 2 of the pockets were ≥7 mm. Treatment with DH, VC, OH, or SRP was provided at baseline and again at month 4. Clinical parameters were recorded monthly. Results: DH and SRP resulted in nearly identical clinical changes over time in both studies. Mean 9 month clinical attachment level gain (ALG) was 0.8 mm for the DH group and 0.7 mm for the SRP group in Study 1, and 0.8 mm (DH) and 0.9 mm (SRP) in Study 2. Mean probing depth (PD) reduction was 1.1 mm for the DH group and 0.9 mm for the SRP group in Study 1 and 1.3 mm for both groups in Study 2. Frequency distributions showed an ALG ≥2 mm in 29% of DH sites versus 27% of SRP sites in Study 1 and 31% of DH sites versus 34% of SRP sites in Study 2. PD reductions ≥2 mm were seen in 32% of DH sites versus 31% of SRP sites in Study 1 and 41% of DH sites versus 43% of SRP sites in Study 2. Comparisons between DH, VC, and OH treatment groups showed DH treatment to be statistically superior to VC and OH. Safety data demonstrated a benign safety profile with use of the DH product. Conclusions: Results of this trial demonstrate that treatment of periodontitis with subgingivally delivered doxycycline in a biodegradable polymer is equally effective as scaling and root planing and superior in effect to placebo control and oral hygiene in reducing the clinical signs of adult periodontitis over a 9‐month period. This represents positive changes resulting from the use of subgingivally applied doxycycline as scaling and root planing was not limited regarding time of the procedure or use of local anesthesia. J Periodontol 1999;70:490‐503.
ISSN:0022-3492
1943-3670
DOI:10.1902/jop.1999.70.5.490