Two Multi-Center Studies Evaluating Locally Delivered Doxycycline Hyclate, Placebo Control, Oral Hygiene, and Scaling and Root Planing in the Treatment of Periodontitis
| Autor: | Vladimir W. Spolsky, R. Lamont MacNeil, Frank J. Raab, Lonnie R. Johnson, Donald H. Newell, Steven Garrett, Charles Q. Harrold, Bradley Beiswanger, Norman H. Stoller, Lawrence E. Wolinsky, William W. Hallmon, Bryan Fitzgerald, Hom-Lay Wang, James T. Mellonig, David F. Atack, Alan M. Polson, G. Lee Southard, Margaret Hill, Ralph M. Arnold, William J. Killoy, Anne P. Polson, Kevin J. Donly, Donald F. Adams, Gerald H. Evans, Philip J. Hanes, Hisham F. Nasi, Mark I. Ryder, Susan P. Duke, Gary Bogle, E. Brady Hancock, Connie Hastings Drisko, Robert Kiger, Carl L. Bandt, R.L. Isaacs, Charles E. Hawley, Simon R. MacNeill |
|---|---|
| Rok vydání: | 1999 |
| Předmět: |
Adult
Moderate to severe Administration Topical Polyesters Dentistry Biocompatible Materials Placebo environment and public health Oral hygiene Doxycycline Hyclate Root Planing law.invention Placebos Drug Delivery Systems Scaling and root planing Randomized controlled trial law Absorbable Implants Periodontal Attachment Loss medicine Humans Periodontal Pocket Single-Blind Method Clinical efficacy Periodontitis Aged business.industry Middle Aged Oral Hygiene medicine.disease Pyrrolidinones Anti-Bacterial Agents Doxycycline Dental Scaling Periodontics Safety Gingival Hemorrhage business Follow-Up Studies |
| Zdroj: | Journal of Periodontology. 70:490-503 |
| ISSN: | 1943-3670 0022-3492 |
| DOI: | 10.1902/jop.1999.70.5.490 |
| Popis: | 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.Each study entered 411 patients who demonstrated moderate to severe periodontitis. Patients had 2 or more quadrants each with a minimum of 4 qualifying pocketsor =5 mm that bled on probing. At least 2 of the pockets wereor =7 mm. Treatment with DH, VC, OH, or SRP was provided at baseline and again at month 4. Clinical parameters were recorded monthly.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 ALGor =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 reductionsor =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.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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Plný text