title: Two multi-center studies evaluating locally delivered doxycycline hyclate, placebo control, oral hygiene, and scaling and root planing in the treatment of periodontitis.
abstract: 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 > or =5 mm that bled on probing. At least 2 of the pockets were > or =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 > or =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 > or =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.
authors.affiliation: Atrix Laboratories, Inc., Fort Collins, CO 80525, USA.
authors.forename: S
authors.initials: S
authors.lastname: Garrett
authors.forename: L
authors.initials: L
authors.lastname: Johnson
authors.forename: C H
authors.initials: CH
authors.lastname: Drisko
authors.forename: D F
authors.initials: DF
authors.lastname: Adams
authors.forename: C
authors.initials: C
authors.lastname: Bandt
authors.forename: B
authors.initials: B
authors.lastname: Beiswanger
authors.forename: G
authors.initials: G
authors.lastname: Bogle
authors.forename: K
authors.initials: K
authors.lastname: Donly
authors.forename: W W
authors.initials: WW
authors.lastname: Hallmon
authors.forename: E B
authors.initials: EB
authors.lastname: Hancock
authors.forename: P
authors.initials: P
authors.lastname: Hanes
authors.forename: C E
authors.initials: CE
authors.lastname: Hawley
authors.forename: R
authors.initials: R
authors.lastname: Kiger
authors.forename: W
authors.initials: W
authors.lastname: Killoy
authors.forename: J T
authors.initials: JT
authors.lastname: Mellonig
authors.forename: A
authors.initials: A
authors.lastname: Polson
authors.forename: F J
authors.initials: FJ
authors.lastname: Raab
authors.forename: M
authors.initials: M
authors.lastname: Ryder
authors.forename: N H
authors.initials: NH
authors.lastname: Stoller
authors.forename: H L
authors.initials: HL
authors.lastname: Wang
authors.forename: L E
authors.initials: LE
authors.lastname: Wolinsky
authors.forename: G H
authors.initials: GH
authors.lastname: Evans
authors.forename: C Q
authors.initials: CQ
authors.lastname: Harrold
authors.forename: R M
authors.initials: RM
authors.lastname: Arnold
authors.forename: G L
authors.initials: GL
authors.lastname: Southard
mesh_terms: D020341:Absorbable Implants; D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001672:Biocompatible Materials / Q000737:chemistry; D012534:Dental Scaling; D004318:Doxycycline / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016503:Drug Delivery Systems / Q000295:instrumentation; D005500:Follow-Up Studies; D005884:Gingival Hemorrhage / Q000188:drug therapy / Q000628:therapy; D006801:Humans; D008875:Middle Aged; D009910:Oral Hygiene; D017622:Periodontal Attachment Loss / Q000188:drug therapy / Q000628:therapy; D010514:Periodontal Pocket / Q000188:drug therapy / Q000628:therapy; D010518:Periodontitis / Q000188:drug therapy / Q000628:therapy*; D010919:Placebos; D011091:Polyesters / Q000737:chemistry; D011760:Pyrrolidinones / Q000737:chemistry; D016745:Root Planing; D012449:Safety; D016037:Single-Blind Method
chemical_list: D000900:Anti-Bacterial Agents; D001672:Biocompatible Materials; D010919:Placebos; D011091:Polyesters; D011760:Pyrrolidinones; C033616:poly(lactide); C038678:N-methylpyrrolidone; D004318:Doxycycline