Adjunctive use of a subgingival controlled-release chlorhexidine chip reduces probing depth and improves attachment level compared with scaling and root planing alone

被引:130
作者
Jeffcoat, MK
Bray, KS
Ciancio, SG
Dentino, AR
Fine, DH
Gordon, JM
Gunsolley, JC
Killoy, WJ
Lowenguth, RA
Magnusson, NI
Offenbacher, S
Palcanis, KG
Proskin, HM
Finkelman, RD
Flashner, M
机构
[1] Univ Med & Dent New Jersey, Dept Oral Pathol, Newark, NJ 07103 USA
[2] Univ Med & Dent New Jersey, Dept Biol, Newark, NJ 07103 USA
[3] Univ Med & Dent New Jersey, Dept Diagnost Sci, Newark, NJ 07103 USA
[4] Univ Med & Dent New Jersey, Dent Res Ctr, Newark, NJ 07103 USA
[5] TKL Res Inc, Ctr Oral Hlth Res, Paramus, NJ USA
[6] Virginia Commonwealth Univ, Dept Periodont, Richmond, VA USA
[7] Eastman Dent Ctr, Dept Periodont, Rochester, NY USA
[8] Univ Florida, Dept Oral Biol, Gainesville, FL 32610 USA
[9] Univ N Carolina, Dept Periodont, Chapel Hill, NC USA
[10] Univ N Carolina, Sch Dent, Dept Dent Ecol, Chapel Hill, NC 27599 USA
[11] Univ N Carolina, Sch Dent, Dept Dent Res, Chapel Hill, NC 27599 USA
[12] Howard M Proskin & Associates, Rochester, NY USA
[13] Astra Pharmaceut LP, Med Affairs, Clin Res, Westborough, MA USA
[14] Perio Prod Ltd, Jerusalem, Israel
关键词
chlorhexidine therapeutic use; controlled clinical trials; delayed-action preparations; periodontitis/therapy; periodontal attachment;
D O I
10.1902/jop.1998.69.9.989
中图分类号
R78 [口腔科学];
学科分类号
1003 ;
摘要
THE PRESENT STUDIES EVALUATED the efficacy of a controlled-release biodegradable chlorhexidine (CHX) (2.5 mg) chip when used as an adjunct to scaling and root planing on reducing probing depth (PD) and improving clinical;attachment level (CAL) in adult periodontitis. Two double-blind, randomized, placebo-controlled multicenter clinical trials (5 centers each) were conducted; pooled data are reported from all 10 centers (447 patients). At baseline, following 1 hour of scaling and root planing (SRP) in patients free of supragingival calculus, the chip was placed in target sites with PD 5 to 8 mm which bled on probing. Chip placement was repeated at 3 and/or 6 months if PD remained greater than or equal to 5 mm. Study sites in active chip subjects received either CHX chip plus SRP or SRP alone (to maintain study blind). Sites in placebo chip subjects received either placebo chip plus SRP or SRP alone, Examinations were performed at baseline; 7 days; 6 weeks; and 3, 6, and 9 months. At 9 months significant reductions from baseline favoring the chlorhexidine chip compared with both control treatments were observed with respect to PD (chlorhexidine chip plus SRP, 0.95 +/- 0.05 mm; SRP alone, 0.65 +/- 0.05 mm, P < 0.001; placebo chip plus SRP, 0.69 +/- 0.05 mm, P < 0.001) and CAL (chlorhexidine chip plus SRP, 0.75 +/- 0.06 mm; SRP alone, 0.58 +/- 0.06 mm, P < 0.05; placebo chip plus SRP, 0.55 +/- 0.06 mm, P < 0.05). The proportion of patients who evidenced a PD reduction from baseline of 2 mm or more at 9 months was significantly greater in the chlorhexidine chip group (19%) compared with SRP controls (8%) (P < 0.05), Adverse effects were minor and transient toothache, including pain, tenderness, aching, throbbing, soreness, discomfort, or sensitivity was the only adverse effect that was higher in the chlorhexidine group as compared to placebo (P = 0.042). These data demonstrate that the adjunctive use of the chlorhexidine chip results in a significant reduction of PD when compared with both SRP alone or the adjunctive use of a placebo chip. These multi-center randomized control trials suggest that the chlorhexidine chip is a safe and effective adjunctive chemotherapy for the treatment of adult periodontitis.
引用
收藏
页码:989 / 997
页数:9
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