Livionex Inc.’s groundbreaking technology has been developed over the last 12+ years in collaboration with two major US universities. Rigorous clinical studies conducted have documented Livionex’s superior efficacy at plaque reduction, inflammation reduction, decreased bleeding on probing and perio pocket depth reduction.

Livionex Dental Gel contains no abrasives, detergents or antimicrobials..

Published and completed study summaries are presented below.

 

Study 1

Plaque, Gingivitis and Gum Bleeding – Summary

A study was conducted at a clinical practice in Milpitas, California. Colgate Total (with Triclosan) dental gel was used as a control dentifrice. All samples were packaged in white tubes and randomly assigned per the protocol. The primary investigator (PI) dentist, hygienist and patient were blinded regarding the assignment of the toothpaste. A single hygienist performed all the measurements to reduce inter-measurement variability.

The measurement indices used were as follows:

Enrolled patients were randomized to either Livionex Dental Gel or Colgate Total. Each patient was instructed to brush twice a day with a soft toothbrush.

The study duration was 4 weeks, with 3 visits: baseline, 2 weeks and 4 weeks. After baseline measurements, the patient received a professional deep cleaning to remove any accumulation of supra- and subgingival plaque. Therefore, patients started with zero plaque after the baseline visit.

Comparison of baseline measurements to end of study (Week 4) measurements showed a statistically significant reduction of plaque, gingivitis and gum bleeding. The percentage reduction in the various indices is shown in Figure 1.

 

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Figure 1: Percentage reduction from baseline indices in a 4 week double blind randomized study conducted in the USA; comparing Livionex Dental Gel to Colgate Total.

Since all patients received a professional deep cleaning after baseline measurements, all started with a zero on the plaque index. As shown in Figure 1, the reduction of plaque measurements showed a reduction of 7% for plaque, which means that 93% of the plaque at baseline had returned at the end of 4 weeks in the Colgate Total group. This is compared to a reduction of 91% for plaque, which means that 9% of the plaque at baseline had returned at the end of 4 weeks in the Livionex Dental Gel group.

Reference: Ralston et al. Comparison of Plaque Removal Capabilities between Two Dentifrices, Oral Hyg Health 2014, 2: 157. doi: 10.4172/2332-0702.1000157.

 

STUDY 2

Plaque, Gingivitis and Gum Bleeding Summary

A double-blind randomized study was conducted at the Beckman Laser Institute at the University of California at Irvine, California. Colgate Total (with Triclosan) dental gel was used as a control dentifrice. All samples were packaged in white tubes and randomly assigned per the protocol. The primary investigator (PI) dentist, technician and patient were blinded regarding the assignment of the toothpaste. A single technician performed all the measurements to reduce inter-measurement variability.

The measurement indices used were as follows:

25 patients were enrolled, with 13 randomized to Livionex Dental Gel and 12 randomized to Colgate Total. Results were averaged on a per-mouth basis.

The study duration was 3 weeks, with 4 visits: baseline, week 1, week 2 and week 3 (end of study).

There was no professional cleaning provided to the patients at baseline. Each patient was provided with brushing instructions and a standard soft toothbrush. All patients were instructed to brush twice a day.

A comparison of baseline measurements to end of study (Week 3) measurements showed a statistically significant reduction of plaque, gingivitis and gum bleeding. The reduction in the various indices is shown in Figure 2 below.

 

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Figure 2: Percentage reduction from baseline indices in a 3 week double blind randomized study conducted in the USA; comparing Livionex Dental Gel to Colgate Total.

References:

  1. Multimodality imaging of the effects of a novel dentifrice on oral biofilm, Ajdaharian J. et al, Lasers Surg Med 2014. PMID: 24916419

  2. Effects of a Novel Dental Gel on Plaque and Gingivitis: A Comparative Study. Dadkhah M, et al. Dentistry 4:239, 2014. doi: 10.4172/2161-1122.1000239

Meta-Analysis: Reduction in Plaque and Inflammation Compared to Other Dental Products

The following methodology was used to conduct a comparative analysis:

  1. Used results from both studies conducted above where a Triclosan/copolymer based anti-plaque, anti-gingivitis toothpaste (Colgate Total) was used as a control..

  2. Used the Standard Differences of plaque Index and gingival index that measured relative efficacy in Triclosan/copolymer based toothpaste (Colgate Total) as a benchmark to compare to a toothpaste containing Stannous Fluoride (Crest).

  3. Reference: Gunsolley, John C., A meta-analysis of six-month studies of antiplaque and antigingivitis agents, JADA, Vol. 137 December 2006, 1649-1657

  4. Compared the standard differences from our studies to the standard difference published in the meta study to calculate relative efficacy of Livionex Dental Gel.

  5. Triclosan/copolymer toothpaste (Colgate Total) is used as a benchmark, and all efficacies are compared to the efficacy of Colgate Total.

  6. Results are shown in Figure 3 below

 

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Figure 3: * The relative numbers represent the standardized mean effect (active agent minus control divided by the standard deviation), which is the relative strength of the active agent in comparison to Colgate Total.

 

STUDY 3

Remineralization

The protocol followed was similar to the published protocol by Maggio, et al.: Evaluation of mouthrinse and dentifrice regimens in an in situ erosion remineralisation model, J Dent. 2010 Nov.

The study utilized 5 subjects. Each subject wore a palatal appliance with 8 enamel blocks and used Livionex Dental Gel as the test dentifrice. All testing was done in a blinded manner, i.e., neither the test subject nor the measuring technician was aware of the gel being tested.

Surface Micro Hardness Remineralization (SMHR) was measured using the Knoop Microhardness test protocol. Livionex dental gel results are compared to results in the Maggio paper in Figure 4 below:

 

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Figure 4: Percentage of surface microhardness recovery 4 hours after brushing. Knoop microhardness test was used. 

 

STUDY 4

In this randomized, prospective, controlled, double-blind pilot study, 10 subjects with periodontitis were recruited. 5 subjects received a Livionex Dental Gel designed to break up and prevent re-accumulation of microbial biofilm. The remaining 5 subjects brushed with Colgate Total with Triclosan. After initial clinical examination, full pocket charting were documented by a clinician. After OCT and intra-oral images, volunteers received standardized oral hygiene instructions. Periodontal pocket charting was determined at beginning and end of the study.

From OCT images, changes in soft and hard supporting tissues of the teeth were measured using software-based point-to-point measurement capability. Changes in periodontal health over time based on clinical measurements were used as the standard for evaluating images of the periodontium.

Pocket depths as measured from the OCT images also reduced progressively, and the soft tissue pocket width decreased too

Using 1-way ANOVA, pocket depths decreased significantly(p=0.043) for the Livionex active group but not for anti-gingivitis control(p=0.084).

 

Figure 5: Pocket Depth changes using clinical observations and Optical Coherence Tomography (OCT).

Reference: Imaging gingivitis response to a novel dentifrice, Janet Ajdaharian, et al, Beckman Laser Institute and Medical Clinic, University of California, Irvine, CA, ASLMS 2013 Annual Conference Poster Session. 

 

STUDY 5

This was an open label single arm six patient study conducted at a major US University. Study duration was 6 months. Subjects were initially enrolled within 4-6 weeks of routine oral prophylaxis provided by their own dental care team. Primary inclusion criterion was the presence of 6 or more periodontal pockets each with a probing depth of > 4mm. periodontal pocket depths (PPD) were measured again at 3 months and at 6 months.

The patients were instructed to brush twice daily with Livionex Dental gel over the 6 month study period, using their usual brushing technique. They were also instructed to continue with any adjunct measures that they had been using previously, such as flossing, Waterpik, mouthwashes and chewing gum. No other dental treatment was provided to these 6 subjects.

On Day 0 350 PPD's measured 4mm or more. PPD depth changes were statistically significant at both 3 month and 6 month time points. Figure 5 shows the changes in the PPD's.

The data clearly demonstrates that diseased PPD's showed a greater improvement compared to relatively healthy PPD's after 3 months of Livionex use, with further improvement at the 6 month time point.

In conclusion, this study demonstrated a potentially beneficial impact of daily brushing with Livionex dental gel in patients with periodontitis.

 

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Figure 6: Number of Perio Pocket Depths that were greater than 4 mm, 5 mm and 6 mm over time.

 

STUDY 6

Fluorescence microscopy of the dental biofilm was performed using a Zeiss LSM 510 Meta Confocal Microscope system.

Red is the bacteria, white is the matrix holding them together on the tooth surface.

The bacteria and matrix are not just lower when brushing with Livionex Dental gel but the structure of bacteria and matrix are also significantly different (healthier).

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Figure 7: Changes in matrix and bacteria on the tooth surface. Same subject was used 
for imaging of effect after 24 hours

 

STUDY 7

This was a double-blind cross over study was to compare the level of plaque control, gingival inflammation and bleeding after use of a Livionex Dental gel (test) vs. Colgate Total with Triclosan (control).

Conclusion: An activated edathamil dental gel formulation provides effective plaque control and reduced gingival inflammation compared to a Triclosan/Co-polymer dental gel.

After coronal polishing, 22 subjects with moderate gingivitis were randomly assigned to brush twice daily with test or control dentifrice for the first study Arm. Plaque, gingival and sulcus bleeding indices were recorded at baseline, week 2 and week 4. Professional coronal polishing was repeated, and then subjects brushed with the second dentifrice for 4 weeks. Clinical indices were again recorded at Baseline, week 2 and week 4.

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Figure 8: Performance of various indices by time point. Yellow lines denote control gel (Colgate Total with Triclosan, Purple lines denote test gel (Livionex Dental Gel). Green dots represent subject evaluation time points (Day 0, 14, 28, 42, and 56). Brushing with the Livionex Dental Gel produced significantly greater levels of plaque reduction versus the Triclosan/copolymer control dentifrice at each time point. 45% less plaque was measured after 4 weeks of test agent use than after control agent use (p<0.000000005). A significant reduction in gingival inflammation from test vs control agent over 4 weeks was also observed (p=0.000342). A significant reduction in gingival bleeding from test vs control agent over 4 weeks was also observed (p=0.00136).

Reference: Nayudu A, Lam T, Ho J, Forghany A, Vu T, et al, (2016). Plaque Removal and Gingival Health after Use of a Novel Dental Gel: A Clinical Study. Dentistry, 6(10), 396. doi:10.4172/2161-1122.1000396

 

STUDY 8

Evaluation of overnight plaque buildup 

Ten subjects participated in this double-blinded, randomized, cross-over study. Volunteers brushed with a washout toothpaste (Tom’s of Maine Whole Care Toothpaste, Kennebunk, ME) twice daily for 7 days. On the evening of Day 7 subjects used the assigned study dentifrice, either the treatment product or the control. Subjects then abstained from oral hygiene and food until their appointment the next morning. The next morning plaque measurement were done in the morning. Subjects brushed with the same toothpaste as the previous night and plaque measurements were repeated.

Control dentifrice was Colgate Total with Triclosan dental gel and test dentifrice was Livionex Dental Gel.

Plaque accumulation and biofilm removal effects differed significantly between the 2 dental gels that were tested.

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Figure 9: Top figure shows the increase in overnight plaque after a single brushing. Bottom figure shows reduction of plaque after 2nd brushing in the morning. Plaque Index used is the Quigley Hein with Turesky modification. Brushing with the Livionex Dental Gel produced significantly greater levels of plaque reduction versus the Triclosan/copolymer control dentifrice at each time point. 45% less plaque was measured after 4 weeks of test agent use than after control agent use (p<0.000000005). A significant reduction in gingival inflammation from test vs control agent over 4 weeks was also observed (p=0.000342).

Reference: Effect of plaque removal mechanisn and duration on oral biofilm, Karan Sahni, et al, Beckman Laser Institute and Medical Clinic, University of California, Irvine, CA, IADR 2015 Annual Conference Poster Session.

 

If you are a dental professional or academic institution interested in conducting research on Livionex Dental Gel, please email Info [at] Livionex [dot] com with your proposal.