Non-surgical periodontal therapy with adjunctive topical doxycycline: a double-blind randomized controlled multicenter study.
OBJECTIVE
Evaluation of the clinical effect of topical application of doxycycline adjunctive to non-surgical periodontal therapy.


METHODS
A total of 111 patients suffering from untreated or recurrent moderate to severe periodontitis at 3 different centers (Heidelberg, Frankfurt, Nijmegen) were treated in this double-blind split-mouth study. In each patient, 3 different treatment modalities were assigned randomly to 3 test teeth: scaling and root planing alone (SRP), SRP with subgingival vehicle control (VEH), and SRP with subgingival application of a newly developed biodegradable 15% doxycycline gel (DOXI). At baseline, clinical parameters were measured at all single rooted teeth using a reference splint: PlI, PPD, relative attachment level (RAL-V), GI. 3 strata were generated according to baseline PPD: (i) 5-6 mm, (ii) 7-8 mm, (iii) > or =9 mm. Not more than 50% active smokers were allowed to each stratum. 3 and 6 months after therapy re-examination was performed by examiners blinded to baseline data and test sites. The statistical comparison of RAL-V gain and PPD reduction between the treatments was based on a repeated measures ANOVA with correction according to Huynh & Feldt. The comparison of SRP versus DOXI was considered as the main study question.


RESULTS
110 patients finished the 3 months and 108 the 6 months examination. The study did not show adverse effects of VEH or DOXI except for one singular inflammation that occurred 2 months after application of the doxycycline gel. DOXI provided statistically significantly more favorable PPD reduction (SRP: -2.4+/-1.4 mm, VEH: -2.7+/-1.6 mm, DOXI: -3.1+/-1.2 mm; SRP versus DOXI p=0.0001, VEH versus DOXI p=0.0066) and RAL-V gain (SRP: 1.6+/-1.9 mm, VEH: 1.6+/-2.2 mm, DOXI: 2.0+/-1.7 mm; SRP versus DOXI p=0.027, VEH versus DOXI p=0.038) than SRP and VEH after 6 months.


CONCLUSIONS
Adjunctive topical subgingival application of a biodegradable 15% doxycycline gel was safe and provided more favorable RAL-V gain and PPD reduction than SRP alone and VEH. Thus, by use of topical doxycycline the threshold for surgical periodontal therapy might be moved toward deeper pockets.
Eickholz
Peter
P
Department of Operative Dentistry and Periodontology, Section of Periodontology, University Dental Clinic, Ruprecht-Karls-University Heidelberg, Im Neuenheimer Feld 400, D-69120 Heidelberg, Germany. peter_eickholz@med.uni-heidelberg.de
Kim
Ti-Sun
TS
Bürklin
Thomas
T
Schacher
Beate
B
Renggli
Heinz H
HH
Schaecken
Matthijs T
MT
Holle
Rolf
R
Kübler
Alexander
A
Ratka-Krüger
Petra
P
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003774:Dental Plaque Index; D012534:Dental Scaling; D004311:Double-Blind Method; D004318:Doxycycline / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; D006801:Humans; D008297:Male; D016555:Matched-Pair Analysis; D008875:Middle Aged; D017622:Periodontal Attachment Loss / Q000188:drug therapy / Q000628:therapy; D010512:Periodontal Index; D010514:Periodontal Pocket / Q000188:drug therapy / Q000628:therapy; D010518:Periodontitis / Q000188:drug therapy / Q000628:therapy*; D014677:Pharmaceutical Vehicles; D015203:Reproducibility of Results; D016745:Root Planing; D018401:Sample Size; D012907:Smoking
D000900:Anti-Bacterial Agents; D005782:Gels; D014677:Pharmaceutical Vehicles; D004318:Doxycycline