Safety and efficacy of a novel nasal spray for maxillary dental anesthesia.

This study examines the efficacy, safety, and tolerability of a nasal spray to induce anesthesia of maxillary teeth. Forty-five healthy adults requiring restoration of one maxillary tooth were randomized in a 1:2 ratio to receive (1) an intra-oral lidocaine-epinephrine injection with buffered saline nasal spray bilaterally, or (2) a tetracaine hydrochloride-oxymetazoline hydrochloride nasal spray bilaterally with sham injection. Primary endpoints were use of rescue anesthesia and patient global pain assessment. Secondary outcomes included vital sign changes, soft-tissue anesthesia, and treatment-emergent adverse events. In intent-to-treat analysis, 25 of 30 patients given nasal spray (83.3%) did not require rescue anesthesia. Proportion of anesthesia successes for nasal spray was significantly different from the hypothesized placebo anesthesia success of 30% (one-sided p value < .0001 by exact binomial test). Mean duration of soft-tissue anesthesia did not differ significantly by treatment for 3 of 4 sites assessed. No serious adverse events or systemic effects were observed. Tetracaine hydrochloride-oxymetazoline nasal spray appears to provide adequate and safe anesthesia for the majority of maxillary dental procedures. Based on the results from this Phase 2 study, pivotal trials are warranted to validate these findings in an expanded patient population.

Metabolomics reveals elevated macromolecular degradation in periodontal disease.

Periodontitis is a chronic inflammatory disease characterized by tissue destruction. In the diseased oral environment, saliva has primarily been considered to act as a protectant by lubricating the tissue, mineralizing the bones, neutralizing the pH, and combating microbes. To understand the metabolic role that saliva plays in the diseased state, we performed untargeted metabolomic profiling of saliva from healthy and periodontitic individuals. Several classes of biochemicals, including dipeptide, amino acid, carbohydrate, lipids, and nucleotide metabolites, were altered, consistent with increased macromolecular degradation of proteins, triacylglycerol, glycerolphospholipids, polysaccharides, and polynucleotides in the individuals with periodontal disease. These changes partially reflected the enhanced host-bacterial interactions in the diseased state as supported by increased levels of bacterially modified amino acids and creatine metabolite. More importantly, the increased lipase, protease, and glycosidase activities associated with periodontitis generated a more favorable energy environment for oral bacteria, potentially exacerbating the disease state.

Clinical effectiveness and soft tissue compatibility of a temporary restorative material.

OBJECTIVE: The purpose of this six-week study was to evaluate in vivo the effectiveness of Systemp.inlay as a temporary restorative material. METHOD: Subjects with the proper indication for a class II restoration were entered into the study. Twenty-three subjects and twenty-nine temporary restorations were evaluated at time of placement, three and six weeks. Two faculty members were calibrated to evaluate the material. Following the six-week trial, the temporary restorative material was removed and the test teeth were restored with a definitive restorative material. RESULTS: The temporary restorative material provided mechanical and anticariogenic protection of tooth structure while preventing dental sensitivity and patient discomfort. It promoted soft tissue health as evidenced by the enhanced plaque and gingival indices found associated with the temporarily restored teeth. Its ease of placement and removal makes it an attractive alternative for the dental practitioner. The change in color of the material over the six-week duration of the study may limit its use to posterior teeth and to lingual/palatal surfaces of anterior teeth. CONCLUSION: Ease of placement and removal and retention of the temporary restorative material were extremely good. Marginal and surface integrity of the material was maintained and no or minimal sensitivity was reported throughout the study. The material did not promote the accumulation of plaque nor result in gingival inflammation. The color change noted was not of clinical importance. Therefore, this temporary restorative material was demonstrated to be clinically effective in Class II cavity preparations.

Dentinal hypersensitivity: review of aetiology, differential diagnosis, prevalence, and mechanism.

Dentinal hypersensitivity is a painful response to a non-noxious stimulus applied to exposed dentine in the oral environment. Dentine exposure results from a combination of two or more aetiological factors that lead to loss of enamel and/or loss of cementum. The hydrodynamic theory is the most accepted theory that explains the excitement of pulpal nerve fibres by a stimulus applied to the exposed dentine. Dentinal hypersensitivity had been reported to affect middle age people most often with no gender differences and has been shown to be influenced by tooth location.

Clinical evaluation of an automatic flossing device vs. manual flossing.

The aim of this study was to compare the effectiveness of an automatic flossing device to manual flossing. A total of seventy adult subjects (20 males and 50 females) were stratified into two groups balanced for age, sex, modified gingival index (MGI), plaque index (PI) and bleeding sites (Eastman Bleeding Index) using screening data. One group was randomly assigned the automatic power flosser and the other group was assigned manual dental floss. The subjects were instructed to brush their teeth twice a day (in the morning and before bedtime) for 30 seconds using the provided manual toothbrush and toothpaste. They were also to use their assigned dental floss or automatic power flosser once in the morning following toothbrushing. There was no significant difference between manual flossing and automatic flossing with respect to the MGI and the BI. There was, however, a significant difference at day 15 in the PI; however, this difference was only 0.73%. There was no significant difference in the PI at day 30 between the two techniques. The statistically significant difference noted in the interproximal PI at both day 15 and day 30 was less than 2%. Since the differences in plaque scores between the groups were so small, there was no apparent impact on gingival health since both flossers resulted in similar health benefits. Since there was a marked preference for the automatic flosser, patient compliance with the automatic flossing device may be better than with manual floss. Therefore, overall gingival health may benefit from this device.

Subantimicrobial dose doxycycline as an adjunct to scaling and root planing: post-treatment effects.

BACKGROUND/OBJECTIVE: Subantimicrobial dose doxycycline (SDD 20 mg bid) plus scaling and root planing (SRP) significantly improved clinical attachment level (CAL) and reduced probing depth (PD) compared with placebo plus SRP in a double-blind, placebo-controlled, multicenter study of patients with adult periodontitis (AP). In a study conducted as a follow-up, the post-treatment effects of SDD were assessed in patients who completed the SRP study. METHODS: The SRP study was a 9-month, active-treatment study and the follow-up was a 3-month, no-treatment study. In the SRP study, tooth sites in qualifying quadrants were scaled and root planed and patients were randomized to receive twice daily SDD 20 mg or placebo. In the follow-up, patients received no study drug; investigators and patients remained blinded to the previous treatment group assignments. Efficacy measures included the change in CAL and PD from baseline values determined at the start of the SRP study in tooth sites stratified by baseline PD (i.e., 0-3 mm, 4-6 mm, > or =7 mm). Safety was evaluated using adverse event data and the results of clinical laboratory tests, oral pathology examinations, and microbiological assessments. RESULTS: Within each disease stratum, the incremental improvements in PD and CAL demonstrated in the SDD group over 9 months of active treatment were maintained through 3 additional months of no treatment. Treatment cessation did not result in an accelerated regression of periodontal health. No differences in the incidence of adverse events (including those related to infection) or laboratory or microbiological parameters were noted between the SDD group and the placebo group. CONCLUSIONS: The administration of SDD 20 mg bid for a period of up to 9 months is not associated with rebound effects or delayed or negative after-effects for a 3-month period after cessation of therapy.

Treatment with subantimicrobial dose doxycycline improves the efficacy of scaling and root planing in patients with adult periodontitis.

BACKGROUND: In a previous study, subantimicrobial dose doxycycline (SDD) significantly improved clinical parameters associated with periodontal health in patients with adult periodontitis (AP) when used as an adjunct to a maintenance schedule of supragingival scaling and dental prophylaxis. In this double-blind, placebo-controlled, parallel-group, multicenter study, the efficacy and safety of SDD were evaluated in conjunction with scaling and root planing (SRP) in patients with AP. METHODS: Patients (n = 190) received SRP at the baseline visit and were randomized to receive either SDD 20 mg bid or placebo bid for 9 months. Efficacy parameters included the per-patient mean changes in clinical attachment level (CAL) and probing depth (PD) from baseline, the per-patient percentages of tooth sites with attachment loss (AL) > or = 2 mm and > or = 3 mm from baseline, and the per-patient percentage of tooth sites with bleeding on probing. Prior to analysis, tooth sites were stratified by the degree of disease severity evident at baseline RESULTS: In tooth sites with mild to moderate disease and severe disease (n = 183, intent-to-treat population), improvements in CAL and PD were significantly greater with adjunctive SDD than with adjunctive placebo at 3, 6, and 9 months (all P <0.05). In tooth sites with severe disease, the per-patient percentage of sites with AL > or = 2 mm from baseline to month 9 was significantly lower with adjunctive SDD than with adjunctive placebo (P<0.05). Improvements in clinical outcomes occurred without detrimental shifts in the normal periodontal flora or the acquisition of doxycycline resistance or multiantibiotic resistance. SDD was well tolerated, with a low incidence of discontinuations due to adverse events. CONCLUSIONS: The adjunctive use of SDD with SRP is more effective than SRP alone and may represent a new approach in the long-term management of AP.

Antiseptics and antibiotics as chemotherapeutic agents for periodontitis management.

Antiseptics and antibiotics have both been used to treat periodontal infections. Although antiseptics and antibiotics have antibacterial properties, they represent two distinct and separate categories for agents. Sustained-release delivery systems have made it possible to use these agents to augment the beneficial effects of mechanical periodontal therapy. This article provides an overview of antiseptics and antibiotics, and compares and makes recommendations for the use of these agents in periodontics. The objective of this article is to provide an understanding of the distinct properties of each of these categories of antimicrobial agents.

Furcation involvement in posterior teeth.

This article presents two cases in which different treatments were used for mandibular molars with furcation lesions. In the first case, a conventional amputation treatment of the distal root was performed to save the mesial root as a terminal tooth, which was used as a partial denture abutment. The second case describes a relatively new technique in which a root perforation was filled with graft material (synthetic bioglass) and covered with a resorbable membrane to treat an iatrogenic furcation lesion adjacent to the mesial root. Twelve months after surgery, periapical radiographs of both treated cases showed increased bone density. Follow-up in both cases--30 months in the first case and 12 months in the second--showed no pathological recurrence or clinical dysfunction. Root amputation may provide an alternative to extraction in periodontally involved molars. Synthetic bone replacement materials combined with guided tissue regeneration may also help to correct osseous defects incurred by recent furcation perforations with associated bone loss.

Local delivery of chlorhexidine.

Clinicians are always looking for new ways to enhance patient care and expand their practices. When evaluating the value of new products on the market, it is important for clinicians to look at what is available, carefully evaluate what is necessary for their patient, and then determine what is best for the practice, the clinician, and the patient. This article discusses the use of chlorhexidine for gaining new attachment and reducing pocket depth. More specifically, the article describes the usefulness, efficacy, and safety of the PerioChip, a chlorhexidine chip that is placed in the periodontal pocket.

Site specific delivery of antimicrobial agents for periodontal disease.

Controlled release delivery systems have become available for the sustained delivery of antimicrobial agents directly to the periodontal pocket. These systems have shown clinical efficacy in periodontal therapy both as adjunctive treatments and as stand-alone therapies. A review of the current state-of-the-art of site specific delivery of antimicrobial agents for the treatment of periodontal disease is provided.

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.

Medications as a risk factor for caries and periodontal disease.

Since our population is aging, patients will present to our offices with more medications than in the past. Although these medications may benefit their general health, they may adversely affect their dental health. Although most medications discussed increase the risk for caries and periodontal disease, a few may actually decrease the risk.

Results of limited initial periodontal therapy in smokers and non-smokers.

Eighty-seven adult patients (54 non-smokers and 33 smokers) with moderate to advanced periodontitis were treated with 1-hour full-mouth subgingival scaling and root planing, with no maintenance recalls, during this 9-month study. Clinical parameters assessed at target sites included probing depth, clinical attachment level, bleeding on probing, gingival index, and plaque index. Data were collected at baseline, and 3, 6, and 9 months. Baseline probing depth for non-smokers was 5.46 +/- .46 mm and for smokers 5.70 +/- 0.66 mm. Data analysis (t test) revealed that both non-smokers and smokers had a statistically significant decrease (P < 0.05) in probing depth at 3 months which was maintained throughout the study. At 9 months non-smokers maintained a mean decrease in probing depth of 0.60 mm and smokers a mean decrease of 0.65 mm. Both smokers and non-smokers displayed a significant gain (P < 0.05) in clinical attachment level after initial therapy when compared to baseline readings. At 9 months the mean gain in clinical attachment level for non-smokers was 0.47 mm and 0.59 mm for smokers. Plaque index scores remained consistent for smokers and non-smokers for the duration of the study. The gingival index at baseline was significantly (P < 0.05) lower in smokers (1.32 +/- 0.45) than non-smokers (1.45 +/- 0.40). By 9 months only the gingival index of non-smokers decreased significantly compared to baseline (1.26 +/- 0.37). Bleeding on probing was a prerequisite for target sites at baseline. At 9 months both smokers (0.67 +/- 0.39) and non-smokers (0.78 +/- 0.30) had a significant decrease in bleeding on probing compared to baseline. At 9 months there were no significant differences between smokers and non-smokers comparing probing depth, clinical attachment level, plaque index, bleeding on probing, and gingival index. The data have shown that smokers and non-smokers responded similarly after 9 months to the limited amount of initial therapy provided.

A clinical comparison of 2 electric toothbrush designs.

A single blind 30 day study compared the reduction of plaque and gingivitis for the Hapika Powerbrush to the Interplak ultra 10 tuft. A longitudinal parallel group design was utilized and screening evaluation was performed to determine patient eligibility prior to study enrollment, 66 subjects were entered into the study and assigned to 1 of 2 groups, each using one of the toothbrushes. At baseline, subjects received an oral soft tissue exam, a dental hard tissue exam, and were scored by the Lobene modification of the Löe and Silness gingival index (GI). Plaque was then disclosed and scored both pre and post brushing using the modified Turesky plaque/debris examination and an interproximal bleeding examination was performed post-brushing. On days 15 and 30, after an oral soft tissue and GI examination, plaque was graded by the Modified Turesky plaque/debris exam. Subjects then brushed and were graded by the Modified Turesky plaque/debris examination and an interproximal bleeding index examination. The results showed that both brushes provided a similar change in clinical indices. All produced a statistically significant reduction from baseline to day 30 for the gingival index (26.5-29.1%), the bleeding index (13.8-24.1%), and the plaque index (16.9-19.4%). A comparison of pre and post brushing scores for the plaque index at 30 showed that both brushes reduced plaque similarly with a statistically significant reduction (P < 0.05) from their pre-brushing plaque index scores at all time periods.

Effects of subgingival chlorhexidine irrigation on peri-implant maintenance.

PURPOSE: To evaluate the effect of irrigation with 0.06% chlorhexidine (PerioGard) (CHX) using a powered oral irrigator (Water Pik) with a special subgingival irrigating tip (Pik Pocket Subgingival Tip) compared to rinsing with 0.12% chlorhexidine gluconate once daily. MATERIALS AND METHODS: Following a prophylaxis, patients were randomly assigned to an irrigation or a rinse group. The following clinical parameters were measured at baseline and at the 3-month end of the study: Modified Gingival Index (MGI), Plaque Index (PI), Bleeding Index (BI), and Calculus Index (CI). Also, a Stain Index (SI) was measured at 3 months. RESULTS: Patients irrigating with diluted CHX showed a statistically significant reduction (P < 0.05) from their baseline in the MGI, PI, BI, and CI scores at 3 months. In the rinse group both MGI and BI showed statistically significant reduction from their baseline (P < 0.05) at 3 months. The rinse group showed a nonsignificant (P > 0.05) increase from baseline in CI and a nonsignificant decrease in PI. Intergroup comparisons showed that CHX irrigation produced statistically significantly greater reductions than CHX rinsing in the PI, MGI, and SI. The irrigation group also showed a greater reduction in BI and CI than the rinsing group but these differences were not statistically significant (P = 0.12). The results of this study suggest that use of diluted 0.06% CHX when used in a powered irrigator may be a valuable adjunct to oral health in patients with implants.