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Soskolne WA, Heasman PA, Stabholz A, Smart GJ,
Palmer M, Flashner M, Newman HN.
Hebrew University-Hadassah Faculty of Dental Medicine, Jerusalem,
Israel.
The safety and efficacy of a degradable, subgingivally placed drug
delivery system containing 2.5 mg chlorhexidine (CHX) were evaluated
in a randomized, blinded, multi-center study of 118 patients with
moderate periodontitis. A split-mouth design was used to compare the
treatment outcomes of scaling and root planing (SRP) alone with the
combined use of SRP and the CHX in pockets with probing depths of 5 to
8 mm. The two maxillary quadrants were used for the two treatment arms
of the study. Scaling and root planing was performed at baseline only,
while the CHX was inserted both at baseline and at 3 months. Clinical
and safety measurements including probing depth (PD), clinical
attachment level (CAL), and bleeding on probing (BOP) as well as
gingivitis, plaque, and staining indices were recorded at baseline,
and at 1, 3, and 6 months. The average PD reduction in the CHX-treated
sites was significantly greater than in the sites receiving SRP alone
at both 3 and 6 months with a mean difference of 0.42 mm (P < or =
0.01) at 6 months. The reduction in CAL at the treated sites was
greater than at the SRP sites, although the difference was
statistically significant at the 6-month visit only. An analysis of
patients with initial probing depths of 7 to 8 mm (n = 56) revealed a
significantly greater reduction in PD and CAL in those pockets treated
with CHX compared to SRP at both 3 and 6 months. The mean differences
between test and control sites at 6 months were 0.71 mm and 0.56 mm PD
and CAL respectively.
Publication Types:
- Clinical trial
- Multicenter study
- Randomized controlled trial
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