Use of a biodegradable chlorhexidine chip in the treatment of adult periodontitis: clinical and radiographic findings.

BACKGROUND: Previous multi-center trials demonstrated the efficacy of a biodegradable chlorhexidine-gelatin chip (CHX) in reducing probing depth in patients with periodontitis. The present study utilized a subset of subjects from the parent study to determine if the CHX chip was effective in maintaining alveolar bone over a 9-month period. METHODS: Forty-five subjects with at least four 5 to 8 mm pockets, stratified by smoking status, were enrolled in this double-blind controlled, placebo-controlled trial. Control groups received either placebo chip plus scaling and root planing (SRP) or SRP alone. Test group subjects received active CHX chip or SRP alone (to maintain the blind). Standardized radiographs were taken for quantitative digital subtraction radiography at baseline and 9 months. RESULTS: At 9 months, 15% of SRP treated subjects experienced loss of bone in 1 or more sites, no subject treated with active chip plus SRP lost bone (P <0.01). At 9 months, significant differences in the change in probing depth and clinical attachment levels favoring the active chip over SRP alone or SRP plus CHX chip were also observed (P <0.05). CONCLUSIONS: These data indicate that the CHX chip, when used as an adjunct to scaling and root planing, significantly reduces loss of alveolar bone.

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

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 multi-center 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 > or = 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.

A comparison of manual and controlled-force attachment-level measurements.

This study compared the intra-examiner and inter-examiner error of 2 constant force probes to the reading of a conventional manual probe. 3 examiners made repeated examinations of attachment level using a modified Florida probe and a manual North Carolina probe (read to 1 mm or 0.5 mm); relative attachment level measurements were made using a Florida disk probe. One probe was used in each quadrant in 8 subjects with moderate to advanced periodontitis. Error was calculated as the mean of the absolute value of the difference between each examination, and the correlation between values at each examination calculated. Statistically-significant differences between probe type, examiners, and sites were detected using a repeated measures ANOVA accounting for the nesting within subjects. There was a significant difference in error by probe type (modified Florida probe 0.62 +/- 0.03 mm, r = 0.86; Florida stent probe 0.55 +/- 0.05 mm, r = 0.82; manual probe to 1 mm 0.39 +/- 0.02 mm, r = 0.88; manual probe to 0.5 mm 0.40 +/- 0.02 mm, r = 0.89; (p < 0.001). Significant differences were observed by examiners (p < 0.01). These data indicate that both manual and controlled-force probes can provide measurement within less than 1 mm of error; however, individual calibration of examiners remains important in the reduction of error.

Efficacy of meclofenamate sodium (Meclomen) in the treatment of rapidly progressive periodontitis.

This 6-month, double-blind, controlled clinical trial determined the efficacy of the non-steroidal anti-inflammatory drug, meclofenamate sodium (Meclomen), as an adjunct to scaling and root planing in the treatment of rapidly progressive periodontitis (RPP). 22 subjects (7 male, 15 female) aged 36.5 +/- 7.88 years with RPP and disease-active sites as determined by pretreatment bone scan had standardized radiographs at baseline and 6 months, and clinical measurements at baseline, 3 and 6 months. Following full-mouth scaling and root planing, subjects were randomly assigned to either a placebo, 50 or 100 mg meclofenamate sodium bid group. Bone change over the 6-month period as assessed by subtraction radiography was the primary efficacy determinant. Specialized software was used to isolate the lesion from the subtraction image and to measure bone change along the root surface. ANOVA using the subject as the unit of analysis revealed a significant dose response (p < 0.001) with the placebo group having a mean bone loss of 0.42 +/- 0.06 mm and the low and high dose groups having mean bone gains of 0.07 +/- 0.05 and 0.20 +/- 0.07 mm, respectively. These findings indicate that meclofenamate sodium may be a useful adjunct in the treatment of rapidly progressive periodontitis.

Elastase as an indicator of periodontal disease progression.

THIS STUDY SOUGHT TO EVALUATE the ability of gingival crevicular fluid (GCF) elastase to predict attachment and bone loss in human periodontitis. Thirty subjects who were medically healthy and had a history of progressive periodontitis were studied with an automated probe. Five sites in each patient were monitored bi-monthly for a 6-month period for attachment loss. Subtraction radiography was utilized at the beginning and end of the study to monitor bone loss. GCF elastase was measured at 0 month and then bi-monthly by collecting GCF on paper strips impregnated with PMN leukocyte elastase substrate inserted into the gingival crevice for 15 seconds. After 8 minutes of reaction time, the strips were scored relative to fluorescent standards in an ultraviolet view box. Strips were then eluted in methanol and total elastase measured by spectrofluorometry. Total elastase was significantly higher in sites demonstrating progressive attachment loss than in inactive sites (2.81 +/- .29 versus 2.03 +/- .07, P less than 0.0005) and sites demonstrating bone loss (2.32 +/- .17 versus 2.01 +/- .08 P less than 0.05). When considering the joint presence of bone loss and attachment loss of 1.0 mm or greater in the 6-month period following a visual elastase kit score of 2 or greater, the test kit shows a sensitivity and specificity of 82% and 66%, respectively. This study demonstrated that GCF elastase levels are significantly higher in sites demonstrating progressive periodontal attachment and bone loss assessed 6 months later and may serve as a predictor of future bone and attachment loss.

The use of repeated measures analysis of variance for plaque and gingival indices.

Clinical trials for anti-gingivitis and anti-plaque agents commonly use the mean of Silness and Löe plaque indices and Löe and Silness gingival indices as response variables. The aim of this report is to determine if data from anti-plaque and anti-gingivitis clinical trials using Silness and Löe plaque indices and Löe and Silness gingival indices satisfy conditions necessary for the use of the univariate or multivariate approach to repeated measures. These conditions are multivariate normality, homogeneity of variance-covariance matrices, and for the univariate approach, a type-H variance-covariance matrix. Data from 5 separate clinical trials representing a wide range in sample size, pretreatment mean gingival and plaque indices and treatment effects were used to test these conditions. Either the univariate or multivariate approach to repeated measures was found to be appropriate for both responses of the 5 clinical trials. Thus, means of Silness & Löe and Löe and Silness gingival indices meet the necessary conditions for use of either the univariate and/or multivariate approach to repeated measures. However, significant time-treatment interactions are a common occurrence in these types of clinical trials and must be evaluated carefully. The analyses in this study were carried out using SAS. Other mainframe statistical software packages and many micro-computer statistical software packages have routines to analyze repeated measures experiments with analysis of variance methods. However, some of the packages may omit the multivariate approach to repeated measures or may not include interactions between within-subject and between-subject effects. These packages should be used with caution.

Rapidly progressive periodontitis. Report of a case.

A nineteen year old white female was referred for an evaluation of severe, rapidly progressive periodontitis. Although the patient was physically healthy and did not demonstrate any remarkable abnormalities in routine laboratory tests or upon physical examination, a detailed immune profile elucidated abnormal findings. Additionally, the patient demonstrated a poor healing response after tooth removal and a continued loss of bone following insertion of dentures.

A longitudinal evaluation of varying widths of attached gingiva.

32 patients with bilateral areas of inadequate attached gingiva on the facial surface of homologous contralateral teeth have been followed for 6 years. Treatment consisted of scaling, root planing, oral hygiene and maintenance at 3- to 6-month intervals or as needed to control inflammation. A free gingival graft was placed on one side (experimental), while the other side served as the unoperated control. Areas of inadequate attached gingiva on control sides, to include those with recession and no attached gingiva, did not demonstrate additional recession or further loss of attachment. Gingival inflammation and plaque were significantly reduced. On experimental sides, the dimension of keratinized and attached gingiva increased and was stable over 6 years. Areas which began with recession and no attached gingiva exhibited a reduction in recession and gain in clinical attachment following the placement of a gingival graft. Examination of patients who had discontinued participation in the study for a period of 5 years revealed a re-establishment of gingival inflammation on the control sides associated with additional recession. Similar changes were not observed in areas treated by a free graft. The findings demonstrate that it is possible to maintain periodontal health and attachment through control of gingival inflammation despite the absence of attached gingiva.

A clinical trial of phenoxymethyl penicillin for adjunctive treatment of juvenile periodontitis.

A double-blind clinical trial of oral penicillin as an adjunct to conventional treatment of localized juvenile periodontitis (JP) was conducted. Sixteen subjects with JP were paired on the basis of general similarity of disease, and within each pair the persons were assigned randomly, one to a placebo group and one to a penicillin group. Neither patients nor therapist/examiner were aware of whether placebo or penicillin was being taken. All subjects received an initial scaling and root planing of all teeth and flap surgery of all affected sites. Every 12 weeks after surgery through Week 62 of the study, root planing and oral hygiene instructions were repeated. Phenoxymethyl penicillin (250 mg qid) or placebo was started the day of surgery and each recall visit and lasted for 10 days. Clinical measurements were made at the beginning of the study and at each recall visit. In both groups there was a significant decrease in plaque scores, gingival inflammation, gingival bleeding and probeable depths for all sites and for affected sites. Similarly there was a significant increase in attachment level and radiographic bone height, and a total elimination of suppuration. The favorable changes were apparent at the first postsurgical recall (Week 26 of the study) and remained essentially the same through Week 62. The magnitude of change in these parameters was similar to that reported by others for treatment regimes including tetracycline therapy. However, there were no differences in any parameters between the placebo and penicillin groups. Half of the subjects (4 in each group) were continued in the study for another 9 months (Week 98).(ABSTRACT TRUNCATED AT 250 WORDS)

Serum antibody reactive with predominant organisms in the subgingival flora of young adults with generalized severe periodontitis.

In the present study we sought to determine whether serum antibody was present against microorganisms which predominate in the subgingival flora of young adults with generalized severe periodontitis (SP). Subjects with SP were often seropositive for Eubacterium brachy, Fusobacterium nucleatum E3C22, and Peptostreptococcus micros, whereas subjects with juvenile periodontitis (JP) and subjects with healthy periodontium (HP) were not. Both SP and JP subjects were more frequently seropositive for Bacteroides gingivalis, F. nucleatum D52B16, and F. nucleatum E1D1 than were HP subjects. The data were most striking for B. gingivalis, for which both the incidence and the magnitude of specific antibody was clearly elevated for SP and JP subject groups. However, SP subjects generally had either a high antibody titer or no detectable titer. In contrast, JP and HP subjects generally had at least very small amounts of antibody. Except at very low levels of antibody, neither SP nor JP groups differed significantly from the HP group for antibody to Eubacterium nodatum, Bacteroides intermedius (homology group 4197 or 8944), or Lactobacillus minutus antibody. There was a high frequency of antibody to E. nodatum, with very high titers in all groups despite the fact that this organism is rarely found in HP subjects. For Eubacterium timidum, the JP group was clearly more frequently seropositive than the HP group. Despite high levels of L. minutus in subgingival flora, none of the 50 SP subjects had a detectable antibody titer, and only four of the HP and JP subjects had detectable antibody. These results indicate that many organisms in the subgingival flora elicit antibody responses. B. gingivalis is probably the best example among the species tested. However, some organisms that are present in high concentration, e.g., L. minutus, apparently fail to induce significant antibody responses.

Comparative bacteriology of juvenile periodontitis.

Statistical comparisons of the floras associated with juvenile periodontitis, severe periodontitis, and moderate periodontitis indicated that differences in the bacterial compositions of affected sites in these populations were not statistically significant. The subgingival flora of affected juvenile periodontitis sites was statistically significantly different from the adjacent supragingival flora and from the subgingival floras of people with healthy gingiva and of children with developing (experimental) gingivitis. However, the subgingival flora of affected juvenile periodontitis sites was not significantly different from the flora of sites with gingival index scores of 1 or 2 in adults with developing (experimental) gingivitis. Of 357 bacterial taxa among over 18,000 isolates, 54 non-treponemal species, 2 treponemal species, and mycoplasma were most associated with diseased periodontal sulci. These species comprised an increasing proportion of the flora during developing gingivitis and constituted over half of the cultivable flora of diseased sites.

Variation in periodontal floras.

Statistical analyses indicated (i) that the floras of individual samples taken from the depth of sulci with nickel-plated Morse 00 scalers were highly reproducible and representative of the flora present at any given time, (ii) that the different compositions of floras of different people with similar clinical signs were statistically highly significant, and (iii) that floras of different affected sites may differ significantly in some (two of three) people at any one time or may differ from week to week in other people (one of three). Thus the flora composition of individual sites appears to be in dynamic flux, probably in response either to environmental changes or to host responses. There was no evidence that double sampling per se (two single passes with 00 scalers) changed the composition of the flora. Repeat samples taken after 1 week were slightly more similar to the initial samples than were samples taken after 3 weeks.

Bacteriology of experimental gingivitis in children.

Children are more resistant to gingivitis than are adults. To determine possible differences in their periodontal floras, an experimental gingivitis study, identical in design to one reported earlier with young adults, was conducted with four 4- to 6-year-old children. The incidence of sites that developed gingival index scores of 2 in children was less than one-third of the incidence observed in adults. The composition of the flora of each child was statistically significantly different from that of any other child or adult. The floras of the children as a group were statistically significantly different from those of the adults. Children had 3-fold greater proportions of Leptotrichia species, 2.5-fold greater proportions of Capnocytophaga species, 2.3-fold greater proportions of Selenomonas species, 2-fold greater proportions of bacterial species that require formate and fumarate, and 1.5-fold greater proportions of Bacteroides species. Adults had greater proportions of Fusobacterium, Eubacterium, and Lactobacillus species. Fusobacterium nucleatum, Actinomyces WVa 963, Selenomonas D04, and Treponema socranskii were predominant species that correlated with increasing gingival index scores in both children and adults.