Clinical Studies

1. A prospective experimental comparative study on the clinical effects of calculus dissolution based oral rinse in gingivitis patients (PDF)

STUDY ZONE: ASIA-INDIA

Study Abstract

This six month double blind clinical study was aimed to evaluate the efficacy of calculus/tartar dissolution based oral rinse (Periogen®) as an adjunct to toothbrushing in gingivitis patients for long-term effects on new supragingival calculus formation. After undergoing a professional dental prophylaxis, 60 gingivitis subjects with a moderate rate of calculus formation were stratified and randomly assigned to one of two groups: Control group (Toothbrushing with regular dentifrice) and experimental group (Toothbrushing with regular dentifrice along with Periogen® mouthrinse twice daily). All subjects in both the groups were assessed with gingival index (GI), plaque index (PI) and new calculus deposition levels using the Volpe-Manhold Index (VMI) after 3 and 6 months. Statistical analysis found that the experimental group (Toothbrushing with Periogen® mouthrinse) demonstrated statistically significantly lower VMI scores (p = 0.001) than control group (Toothbrushing only). In experiment test group A, there was decline in VMI score from 3 to 6 months by 23.12% as compared to group B where there was continuous increase in VMI scores from 3 to 6 months by 22.16%. Periogen® containing tetrapotassium pyrophosphate and sodium tripolyphosphate as the anticalculus agent provides a clinically relevant reduction in calculus formation in subjects with a moderate rate of such formation.

Study Outline(PDF)

2. Periogen® Oral Rinse Study to Determine the Effect of Periodontal Disease (PDF)

STUDY ZONE-NORTH AMERICA- USA

Study Abstract

Aim and purpose: The cause of periodontal disease is bacterial film known as plaque. Bleeding upon probing (BUP) is usually the first signed of periodontal disease. The purpose of the study is to determine the effect of Periogen® oral rinse on plaque index (PI), probing depth (PD), BUP and calculus after 90 days of daily Periogen use. Materials and method: A total of 53 systemically healthy subjects enrolled and randomly assigned in this double blinded and placebo- controlled clinical trial. At baseline, and at 90th day, PI, BUP, PD and photographs were taken and recorded. Participants were instructed to rinse with the assigned oral rinse twice daily using a water flosser. BANA (Benzoyl-DLArginie NaphthyAMide) chair side periodontal test were performed to detect presence of oral bacteria in plaque. Results: PI, BUP and PD in Periogen® oral rinse group had more significant improvement as compared to placebo group after 90 day used of the product. However, visible calculi were not much significant difference between groups especially true for subjects who have Calculi Bridge for many years. Overall improvement in PI, BUP, PPD were seen in Periogen® group as compared to placebo group. Summary and conclusions: After using for 90 days, plaque index, bleeding upon probing, and periodontal pocket depth were reduced more in Periogen® oral rinse group compared to the placebo. However, no significant difference was found between groups. In conclusion, Periogen® oral rinse is significantly better in reducing periodontal disease as compared to just using water flosser alone.

3. The effect of Periogen® solution on dental calculus In-vitro – A pilot study (PDF)

STUDY ZONE-EUROPE-HUNGARY

Study Abstract

Purpose: Calculus can accommodate on teeth and prosthetic restorations when the patient’s oral hygiene is poor. Hardened calculus cannot be removed by patients, it needs professional cleaning using ultrasonic scaler or hand instrument. Solutions dissolving and preventing accumulation of dental calculus may help to keep dentures clean. The aim of this investigation was to examine the effect of Periogen® on dental calculus in vitro.Materials and methods: Calculus were collected via scaling from patients during a routine dental check-up. The samples were stored in carbamide peroxide solution (5%) for 24 hours, then rinsed and stored in distillated water. First the Ca2+ content of the calculus was determined by photometric method (Moorehead,1974) after treating with cc. hydrochloric acid solution for one hour. The calculus samples were put in Periogen® solution, prepared according to manufacturer’s instruction, for 16 hours, then crushed and put in Periogen® solution with the same concentrate for 4.5 hours.The Ca2+ dissolved from calculus was measured using same photometric method. Results: Calculus samples contained 26mg/100mg Ca2+, which is similar to dentin (27-28 mg/100mg), and to enamel (36 mg/100mg). The Ca2+ dissolved from calculus after treating with cc. hydrochloric acid for 1 hour was considered 100%. Ca2+ dissolution was 1.5% after 16 hours (0.09%/h) and 5.45% (1.21%/h) for the next 4.5 hours after pulverizing the sample. This showed Periogen® Ca2+ dissolution was 385 μg/100mg after 16 hours direct contact with the material. Conclusion: The experiment showed that pulverizing the previously hard calculus was done easily after soaking it in Periogen®. The ability of Periogen® to soften the calculus needs to be further investigated. The solution could help patients cleaning their removable dentures after overnight soaking in Periogen®.

4. A Six-Month Clinical Study to Evaluate the Effects of Sodium Tripolyphosphate and Tetrapotassium Pyrophosphate Based Calculus Dissolution Oral Rinse in Patients with Zirconium Dioxide and Titanium Dental Implants (PDF)

STUDY ZONE-MIDDLE EAST-(UAE) SHARJAH & DUBAI

Study Abstract

Aim: To clinically evaluate the effects of a novel anti-calculus mouth rinse containing sodium tripolyphosphate and tetrapotassium pyrophosphate (Periogen®, USA) on development of gingivitis and plaque around dental implants versus control over a period of six months. Material and methods: This was a randomized, 6 month, parallel groups, double blind, single center clinical trial. Forty subjects with present dental implants (22 zirconium dioxide and 20 titanium) were randomly assigned to one of two subgroups: control group (regular brushing) and test group (regular brushing followed by using the calculus dissolution based oral rinse). All subjects were assessed with gingival index (GI), plaque index (PI) and Volpe-Manhold calculus index (VMI) after 3 and 6 months. Results: Statistical analysis found that test group in both zirconium dioxide and titanium group demonstrated statistically significant lower GI, PI and VMI scores. Conclusion: This study demonstrates that calculus dissolution based Periogen® mouthrinse provided clinically significant reduction in calculus formation in subjects with zirconium dioxide and titanium dental implants when used twice daily for 6 months as an adjunct to toothbrushing.

5. Anti-Plaque And Antimicrobial Efficiency Of Different Oral Rinses in a 3-Day Plaque Accumulation Model (PDF)

STUDY ZONE-EUROPE-ITALY

The idea of employing a chemical agent that would act in a manner identical to that of a toothbrush and remove bacteria from the tooth surface is an attractive proposition. Despite the principle nature of the toothpaste vehicle, most chemical plaque-control agents have been evaluated and later formulated in the mouthrinse vehicle. The current studies aimed to investigate the persistence of antimicrobial action and plaque inhibitory properties of a new oral alcohol free rinse by comparison with positive control, chlorhexidine 0.12%, and placebo control, physiologic saline solution, rinses. The evaluation of the antimicrobial activity was performed by saliva samples collected during the 3-days of usage. The results indicate that this new oral rinse have equivalent plaque inhibitory action to chlorhexidine as a rinse. Similar to chlorhexidine, the plaque inhibitory action of the rinses appears to be derived from a persistence of antimicrobial action in the mouth. Furthermore we reported no side effects during the study, with the additional benefit of no alcohol presence in the rinse solution.

6. Comparative Effect of Chlorhexidine and Anti-Calculus Mouth rinse on Dental Plaque, Gingival Inflammation and Calculus Formation on Plaque Induced Gingivitis Patients (PDF)

STUDY ZONE- ASIA-VIETNAM

Background: Chlorhexidine (CHX) is considered as a gold standard of antimicrobial rinses. Various anti-calculus mouth rinse is available in the market However, little is known of its effectiveness. Aim: The aim of this study was to evaluate the clinical changes after the usage of anti-calculus mouth rinse and 0.12% CHX. Subjects and Methods: In a randomized clinical trial, 30 patients with dental plaque-induced gingivitis were assigned to two groups i.e. Experiment Group A (Anti-calculus mouth rinse) and Control Group B (0.12% Chlorhexidine mouth rinse). Gingival index, plaque index, calculus index and salivary concentration scores were recorded at baseline and six months along with the feedback questionnaire. Results: Intragroup comparison in both groups showed that all the clinical parameters scores were statistically significant after six months as compared to baseline. Intergroup comparison showed that Anti-calculus mouth rinse statistically showed more significant reduction in all the clinical parameters scores from base line to six months. Conclusion: Anti-calculus mouth rinse significantly reduced the clinical symptoms of plaque-induced gingivitis compared to 0.12% CHX with no adverse effects.

7. Maturation Index Assessment of Sodium Tripolyphosphate and Tetra Potassium Pyrophosphate Based Calculus Dissolution Mouthrinse in Moderate Gingivitis Patients (PDF)

STUDY ZONE- ASIA-INDONESIA

Abstract Background: Poor oral hygiene and colonization of dental plaque is likely to play an important role in periodontal disease progression that further alters systemic health. Mouthrinse are often used as adjunct with tooth brushing to supplement plaque control. The aim of this study was to evaluate the clinical efficacy of anticalculus Mouthrinse in Maturity Index of oral epithelium of moderate gingivitis patients. Materials and methods: Sixty subjects of moderate gingivitis were divided into three categories with twenty subjects in each group. Group A (Professional Prophylaxis followed by regular brushing and calculus dissolution-based test mouthrinse), Group B: (Regular brushing and calculus dissolution based test Mouthrinse) and Group C: (Professional Prophylaxis followed by regular brushing only). The gingival epithelium smear was done two times for each subject, the first day prior to the use of mouthwash and on the 6th day after using mouthrinse for 5 consecutive days. Results: The subjects under group A (Professional prophylaxis and Test mouthrinse) showed 19.11% turn overrate followed by group B (Test mouthrinse only) with 14.08 % and last with Group C (Professional prophylaxis) with only 6.49%. Conclusion: The test mouthrinse in this study significantly proved to switch the Maturation Index and this Mouthrinse will promote wound healing.

8. The Efficacy of Anticalculus Mouth Rinse in Moderate Gingivitis Patients with and without Professional Interventions (PDF)

STUDY ZONE- ASIA-INDONESIA

Aim: Gingivitis has been defined as the reversible dental plaque‑induced inflammation of the gingiva without detectable bone loss or clinical attachment loss. It is frequently encountered in dental practice and affected people of all ages and describes the condition of the dental soft tissue. There is always a correlation between the presence of calculus and the prevalence of gingivitis. The aim of this clinical study was to assess the efficacy of anticalculus mouthwash on reduction of plaque and calculus with and without professional intervention. Materials and Methods: A total of 40 volunteers with clinical signs of moderate gingivitis were selected and after a washout period of 2 weeks divided into groups, with and without any professional intervention. The patients were instructed to use anticalculus mouth twice daily. Clinical assessment was carried out using the plaque index based on Silness and Loe method, gingival index based on Loe and Silness method, and calculus index of Oral Hygiene Index‑Simplified at baseline, 1 month, and 2‑month days of the anticalculus mouthwash use. Statistically analysis was carried out using the Kruskal–Wallis and Mann–Whitney test for comparative analysis. Results: The study proved that anticalculus mouthwash was effective in lowering all the clinical scores both with and without any professional intervention. However, the optimal results were achieved when combined with professional scaling. Conclusion: Anticalculus mouthwash is effective in controlling plaque‑induced gingivitis and lowering clinical scores.