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Objective Nutraceutical agents have been demonstrated as adjuncts for the treatment of several inflammatory diseases. The present study analyzed and compared new nutraceutical agent as an adjunct to Scaling and root planing (SRP) versus SRP alone for the treatment of periodontitis. Materials and methods Sixty-six patients with moderate periodontitis were enrolled. Through a randomized design, the patients were randomly assigned to SRP + nutraceutical agent (test group) or SRP alone (control group). Patients were regularly examined the clinical, inflammatory mediators and visual analogue scale (VAS) changes over a 6-month period. Clinical attachment level (CAL) was the primary outcome variable chosen. Gingival crevicular fluid (GCF) inflammatory mediator change and the impact of treatment on VAS were evaluated through a linear regression model. Results Both treatments demonstrated an improvement in periodontal parameters compared with baseline. After 6 months of treatment, compared with the control group, the test group determined a significant probing depth (PD) ( p  = 0.003) and bleeding on probing (BOP) reduction ( p  < 0.001), while CAL gain was significantly obtained at 30 and 60 days after treatment ( p  < 0.05). In the test group, the level of inflammatory mediators was significantly reduced compared with the control group ( p  < 0.05). The linear regression analysis demonstrated that the nutraceutical agent exerted, in the test group, a significant influence on VAS at 6, 12, 24, and 48 h after treatment ( p  < 0.05). Conclusions Nutraceutical agent resulted in a more significant reduction in clinical, inflammatory mediators and short-term pain compared with SRP alone. Clinical relevance Nutraceutical agent, when combined with SRP, was demonstrated to be effective in reducing periodontal parameters and controlling the levels of inflammatory mediators and pain in patients with periodontitis.

Background The gold standard in treatment of periodontitis is mechanical removing of dental biofilm but using local delivery drugs as adjunctive to SRP is widely used to modulate inflammatory host and eradicate microbes. Tea tree oil (TTO) has a broad-spectrum antimicrobial, anti-inflammatory, antifungal, antiviral, antioxidant effect. This study aimed to assess clinically and biochemically the effect of intrapocket application of TTO ( Melaleuca alternifolia ) gel adjunctive to scaling and root planing (SRP) in the treatment of stage 2 (moderate) periodontitis and to correlate the biochemical levels with clinical response. Methods A randomized, controlled clinical trial was conducted on thirty patients with stage 2 periodontitis. Patients were equally divided into two groups: Control Group treated with (SRP) alone and Test Group treated with SRP and locally delivered 5% TTO gel. Clinical assessment included pocket probing depth (PPD), clinical attachment loss (CAL), gingival index (GI) and bleeding on probing (BOP) measured at baseline and after 3 and 6 months. The level of matrix metalloproteinase-8 (MMP-8), in the gingival crevicular fluid (GCF) was also assessed at baseline and after1, 3 and 6 months by Enzyme-linked immunosorbent assay (ELISA) kit. Chi-square, Student t- tests, Mann–Whitney U test and Spearman correlation were the statistical tests used in the study. Results An improvement of all clinical and biochemical parameters was observed (at p  < 0.001) in both groups. A significant difference between the two groups was found in both clinical and biochemical parameters. Conclusion The local delivery of TTO gel adjunctive to SRP proved to be effective in the treatment of stage II periodontitis. Trial registration The study was retrospectively registered at clinicaltrials.gov NCT04769271, on 24/2/2021.

Objectives To determine whether azithromycin (AZI) as an adjunct to scaling and root planing (SRP), when compared to placebo, decreases the number of sites demonstrating pocket depth (PD) ≥ 5 mm and bleeding on probing (BOP) 12 months post-treatment in stage III/IV periodontitis patients. Materials and methods In a double-blind randomized parallel-arm placebo-controlled trial, 40 stage III/IV periodontitis patients received steps 1 and 2 of periodontal treatment in two sessions within 7 days. Patients then received systemic antibiotic therapy ( n = 20; AZI 500 mg/day, 3 days) or placebo ( n = 20). Additional instrumentation of residual diseased sites (DS) — sites with PD ≥ 5 mm and BOP — was performed at the 3-, 6- and 9-month follow-ups. The primary outcome variable was the number of DS at the 12-month re-evaluation. Using a multivariate multilevel logistic regression model, the effects of gender, age, antibiotic therapy, presence of Porphyromonas gingivalis or Aggregatibacter actinomycetemcomitans , smoking, tooth being a molar and interdental location were evaluated. Results The number of DS after 12 months was similar in the test (median (Me) = 4, interquartile range (IQR) = 0–6) and control (Me = 3, IQR = 1–6.5) groups. Both groups showed substantial but equivalent improvements in periodontal parameters, with no intergroup differences at initially shallow or deep sites. The logistic regression showed a lower odds ratio (OR) for the healing of DS on molars (OR = 0.29; p < 0.001) and in smokers (OR = 0.36; p = 0.048). Conclusion Stage III/IV periodontitis patients showed significant but comparable improvements in periodontal parameters and the number of residual DS at the 12-month revaluation regardless of treatment type. This may have been the result of the additional instrumentation received by patients at residual DS in both treatment groups. Clinical relevance Treatment with AZI + SRP provided no additional benefits after 12 months in terms of periodontal parameters or the number of persisting sites with PD ≥ 5 mm + BOP as compared to SRP plus placebo. Trial registration EUDRA-CT: 2015-004306-42; https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-004306-42/SI , registered 17. 12. 2015.

BackgroundGingivitis and periodontitis are prevalent inflammatory diseases of the periodontal tissues. Current treatments are often ineffective or do not prevent disease recurrence. Uncontrolled complement activation and the resulting chronic gingival inflammation are hallmarks of periodontal diseases. We determined the efficacy and safety of a complement 3-targeted therapeutic, AMY-101, which was locally administered to adult patients with periodontal inflammation.MethodsThirty-two patients with gingival inflammation were enrolled in a randomized, placebo-controlled, double-blind, split-mouth phase IIa trial that followed a dose escalation study to select a safe and effective dose in an additional 8 patients. Half of the patient's mouth was randomly assigned to AMY-101 (0.1 mg/site) or placebo injections at sites of inflammation, administered on days 0, 7, and 14, and then evaluated for safety and efficacy outcomes on days 28, 60, and 90. The primary efficacy outcome was a change in gingival inflammation, measured by a modified gingival index (MGI), and secondary outcomes included changes in bleeding on probing (BOP), the amount of plaque, pocket depth, clinical attachment level, and gingival crevicular fluid levels of matrix metalloproteinases (MMPs) over 90 days.ResultsA once-weekly intragingival injection of AMY-101 for 3 weeks was safe and well tolerated in all participants and resulted in significant (P < 0.001) reductions in clinical indices measuring gingival inflammation (MGI and BOP). AMY-101 significantly (P < 0.05) reduced MMP-8 and MMP-9 levels, indicators of inflammatory tissue destruction. These therapeutic effects persisted for at least 3 months after treatment.ConclusionAMY-101 treatment resulted in a significant and sustainable reduction in gingival inflammation without adverse events and, we believe, merits further investigation for the treatment of periodontitis and other oral or peri-implant inflammatory conditions.Trial registrationClinicalTrials.gov identifier NCT03694444.FundingAmyndas Pharmaceuticals.

Background: The development of periodontal disease has been thought to be associated with several restricted members of the oral anaerobic species, such as black-pigmented Porphyromonas species and Actinobacillus actinomycetemcomitans (Aa), in the subgingival environment. Apart from bacteria, certain viruses and fungi that are associated with periodontal disease are also present in the subgingival plaque. Materials and Methods: A randomized, double-blind, crossover split-mouth design was performed. A total of 16 patients suffering from generalized chronic periodontitis were selected for the study. The study period of 18 days was divided into two time-intervals, i.e. baseline (0 days) to 7 th day, with a washout period of 4 days followed by a second time interval of 7 days. The use of ozone and chlorhexidine gluconate (CHX) irrigation was randomized. Both the patient and the clinician evaluating the clinical parameters were blinded regarding the type of irrigation used. Results: The interpretation of clinical and microbial data is from baseline to 7 th day. A higher percentage of plaque index (12%), gingival index (29%) and bleeding index (26%) reduction was observed using ozone irrigation as compared to chlorhexidine. The percentile reduction of Aa (25%) using ozone was appreciable as compared to no change in Aa occurrence using chlorhexidine. By using O 3 and chlorhexidine, there was no antibacterial effect on Porphyromonas gingivalis (Pg) and Tannerella forsythensis. The antifungal effect of ozone from baseline (37%) to 7 th day (12.5%) was pronounced during the study period, unlike CHX, which did not demonstrate any antifungal effect. Conclusion: Ozone may be considered as an alternative management strategy due to its powerful ability to inactivate microorganisms. Also, there is growing evidence that ozone can be employed as a useful therapeutic agent in both dentistry and medicine.

This study aims to evaluate the efficacy of photodynamic therapy as an adjunct to conventional endodontic treatment in patients with apical periodontitis and fistulas. In this study, a fistula is characterized as a pathological conduit originating from the infected region at the root apex of the tooth, traversing the oral mucosa, and extending to the external surface of the gingiva. This pathological condition frequently complicates the management of endodontic infections, thereby necessitating the evaluation of supplementary therapeutic interventions. The standard treatment for endodontic infections involves thorough disinfection of the root canal system to remove microbial contamination from the canal and surrounding tissues. To potentially augment the efficacy of conventional treatment, aPDT is proposed as a supplementary, non-invasive technique. This innovative technique uses a photosensitizer, which is a light-sensitive dye, in combination with a light source to produce reactive oxygen species. Reactive oxygen species can effectively target and eliminate bacteria in the root canal system, potentially enhancing treatment outcomes. The study will involve 140 teeth with apical periodontitis and fistulas. The teeth will be randomly assigned to one of two treatment groups. Group I will receive only the conventional endodontic treatment, which includes root canal cleaning, shaping, and obturation. Group II will undergo the same conventional endodontic treatment, but with an additional step of aPDT. The aPDT procedure involves applying a photosensitizer to the root canal and irradiating it with light to produce reactive oxygen species. Each group will consist of 70 teeth to ensure adequate statistical power. The primary outcome is fistula resolution, assessed clinically at 15 and 30 days post-treatment. The secondary outcome is the comparison of apical radiolucency from periapical radiographs to evaluate healing and reduction of periapical pathology. The study aims to determine if adding aPDT significantly improves the management of apical periodontitis and overall success rates of endodontic treatment. The results will provide insights into the effectiveness of aPDT as an adjunctive treatment and its potential benefits in clinical practice.

Background: Periodontitis is a chronic disease with a complex etiology that includes bacterial colonization, excessive inflammation, and oxidative stress. The hormone melatonin has antioxidant properties and might contribute to alleviating chronic conditions by reducing oxidative stress. The aim of this study was to analyze the effect of exogenous melatonin on periodontitis in an animal model of the disease as well as in patients with periodontitis. Methods: In rats with ligature-induced periodontitis, melatonin was administered in drinking water for two weeks. In the human study, patients with treatment-resistant periodontitis were asked to rinse their mouths with a solution containing melatonin or placebo every evening for two weeks. Periodontal status as well as salivary markers of oxidative stress were assessed at the end of the study. Results: Neither radiography nor μCT revealed any significant effects of melatonin on alveolar bone loss. Gum recession was the only improved macroscopic measure in rats (p < 0.05). Analysis of salivary markers of oxidative stress revealed no effects of treatment in rats or humans despite clearly elevated melatonin concentrations in melatonin treated groups. Conclusion: Our results do not support the use of melatonin for the treatment of periodontitis. However, the negative outcome is limited by the short duration of the study and the chosen route of application as well as the dose of melatonin.

Patients with chronic periodontitis underwent periodontal surgery and received daily injections of teriparatide or placebo. The primary outcome was radiographic linear resolution of alveolar bone defects. Teriparatide was associated with improved outcomes. Periodontitis affects more than one in five American adults, is a major cause of tooth loss, and is associated with systemic disorders such as diabetes mellitus, preterm low birth weight, and cardiovascular disease. 1 – 5 Therefore, the development of predictable procedures to regenerate oral bone that is lost owing to developmental defects, trauma, or disease is desirable. A systemic anabolic agent to promote oral bone regeneration would be useful. Teriparatide, which consists of the first 34 amino acids of parathyroid hormone, is an anabolic agent approved by the Food and Drug Administration for the treatment of osteoporosis. Multiple clinical trials have . . .

The primary aim of the present study was to compare the reduction in periodontal probing depth after the use of either local or systemic adjuvant antibiotics during non-surgical periodontal therapy at baseline and the six-month follow-up. Secondary aims were to compare other clinical outcomes, total bacterial count, and relative expression levels of certain pro-inflammatory mediators following the use of locally and systemically delivered adjuvant antibiotics during the initial non-surgical periodontal therapy (NSPT). A total of 38 periodontitis stage III grade B or C patients were randomly and equally assigned to receive either local (LA) (tazobactam + piperacillin preparation) or systemic antibiotics (SA) (amoxicillin and metronidazole combination) during NSPT. Clinical periodontal parameters (periodontal probing depth, clinical attachment level, bleeding on probing, and plaque index), and microbiological and immunological parameters: total bacterial count, and relative expression levels of IL-17 and TNF-α were evaluated at baseline and six months after NSPT. Both LA and SA significantly improved all clinical parameters after six months (p<0.001 for all comparisons). While a significant decrease of total bacterial count was observed after LA (p=0.001) and SA treatment (p=0.013), the insignificant differences between the two groups were observed after the sixth-month follow-up (p>0.05). Conversely, relative gene expression levels of IL-17 and TNF-α did not differ significantly between LA and SA six months after the NSPT. The insignificant differences between these cytokines' relative levels were observed in both SA and LA between baseline and follow-up measurements. The adjuvant use of piperacillin + tazobactam led to the comparable improvement of clinical, microbiological and immunological parameters to the conventional use of amoxicillin and metronidazol combination six months following the initial therapy of periodontitis. Therefore, these locally delivered antibiotics might be a promising alternative to the standard use of systemic amoxicillin and metronidazol combination during initial therapy of stage III periodontitis.

Periodontal disease is among the sixth most common inflammatory diseases worldwide with high risk to promote complications from other inflammatory diseases including diabetes, cardiovascular disease and Alzheimer's Disease. Failure of active resolution of inflammation pathways is implicated in pathogenesis of periodontal diseases, including gingivitis. Lipoxin A4 (LXA4), a member of the specialized pro-resolving lipid mediators (SPMs) that drive resolution of inflammation GPC-receptor mediated pathways, offered therapeutic advantages in preclinical models of periodontitis. We conducted a randomized, placebo-controlled, parallel-group Phase 1 clinical trial to determine the safety and preliminary efficacy of an LXA4 analog in patients with gingival inflammation. One hundred twenty-seven (127) individuals were randomized to daily use of an oral rinse containing a LXA4 mimetic, methyl ester-benzo-lipoxin A4 (BLXA4), placebo rinse or a no-rinse control group for 28 days. Treatment emergent adverse events (TEAEs) were assessed for safety, the primary outcome. Secondary outcomes included the change in the level of gingival inflammation and periodontal pocket depth (PD). Serum SPMs were monitored using targeted lipid mediator lipidomics to assess potential systemic impact of BLXA4. The frequency of TEAEs was similar in BLXA4 and placebo-treated groups with no study-related SAEs. Once-daily rinsing with BLXA4 for 28-days resulted in a greater decrease in gingival inflammation compared to placebo rinse and no-rinse control groups (mean change: 0.26 GI unit 0.21 and 0.17, respectively). PD reduction was also greater with BLXA4 oral rinse compared to placebo and no-rinse groups (mean reduction: 1.23 mm . 0.71 mm and 0.46 mm, respectively). Topical application of BLXA4 increased serum levels of SPMs. Treatment with BLXA4 reduces local inflammation, and increases abundance of pro-resolution molecules systemically, which may dampen inflammation that can mediate progression and course of inflammatory diseases beyond periodontitis. ClinicalTrials.gov, identifier (NCT02342691).