PerioCreamBrochure DRAFT dont use

2 Phase
Scaling &
Root Planing
Aftercare Kit

Ready to use paste dressing
and gum brushing solution

Made in Switzerland

bonyf was incorporated in 1979 in the Principality of Liechtenstein, and has been specialising for over 30 years in the
development and production of medical and cosmetic devices. The products are manufactured in Switzerland under
the highest standards and distributed worldwide by dispensing chemists, dentists and other specialist sales outlets.

About bonyf Quality Contact

We at bonyf develop and bonyf strives to ensure that its Registered Office:
manufacture an extensive range of products maintain a high and Heiligkreuz 16
high quality and innovative oral, consistent level of quality. FL-9490 Vaduz
dental and denture care products, Liechtenstein, Europe
which fall under the guidelines of The products are developed and
the European Medical Device produced at our manufacturing plant Phone: +423 232 78 15
Directive. bonyf is an ISO 9001 and in Buchs, Switzerland. The Fax: +423 232 51 88
ISO 13485 certified company. production facilites and specialised Website: www.bonyf.com
machinery are in line with the latest Email: [email protected]
Innovation technologies which ensures that the
stringent demands of medical device Company Profile
Innovation is key in today’s fast development and manufacturing are
moving world and we are met. Founded: 1979
committed to the ongoing Employees: 25+
development of new and A dynamic and controlled Headquarters: Vaduz,
innovative products. production environment enables Liechtenstein
bonyf to maintain an efficient Manufactured: Buchs,
worldwide export service in over 35 Switzerland
countries. Exported: in over 35 countries

Innovation • Excellence • Service

Introduction to PerioCream®

Periodontitis also known as gum disease, begins with the growth of bacteria in the Post SRP
mouth and can possibly lead to further complications such as halitosis, damage to Phase 1
gum tissue surrounding the teeth and teeth loss. The onset of periodontitis is called Phase 2
gingivitis, and symptoms are most commonly characterised by bleeding gums,
inflammation of the gums and halitosis.

Patients suffering from gingivitis usually undergo a scaling and root planing (SRP)
procedure to release the bacteria and plaque build-up which is deeply rooted
within the periodontal pockets (abnormal depth of gingival sulcus at the point
where the gums meet the teeth). This treatment is relatively invasive and causes
inflammation of the gums, bleeding and pain. Therefore it is important that the
treated area is isolated and protected from post treatment infections in order to
allow the gums to recover properly.

This PerioCream kit provides a solution for the isolation and management of
treated areas following SRP. It also includes an aftercare kit for the patient, to aid in
a speedier and less painful recovery of the gums. The PerioCream kit comes in two
phases.

The first phase consists of a unique Olive oil based pre-mixed periodontal paste
dressing, which is applied by the dentist directly onto the treated areas of the gums
to isolate them and provide protection from cross-contamination. This also grants a
reduction of pain sensation to the patient.

The second phase consists of an effervescent tablet, used by the patient to make a
liquid gum brushing solution. The patient is advised to brush with this solution over
a period of 10 days, and this results in a dramatic reduction of bleeding, pain, and
also clinical parameters such as gingival index, plaque index and halitosis.

Pre SRP Post SRP and Post Phase 1 & 2

Phase 1: Paste dressing application

Simple 3-step approach

Prepare pre-filled syringe
Apply product

Spread product Dentist application

How does this paste dressing help? Protects
Soothes
Phase 1 of the PerioCream Kit is a paste dressing, Prevents cross-contamination

which provides protection for bleeding and Phase 1
Protective
inflammed gums. This paste is applied by the paste dressing
Inflammation
dentist following SRP and can last up to five hours following SRP

on the gums. The paste contains up to 30% Olive

oil and has mucco-adhesive properties, which

means that on contact with water and saliva the

product becomes sticky. This helps to create a

strong barrier which provides a good isolation of

the affected area. Dentists may choose to use this

paste directly after the SRP treatment, or also

during the SRP treatment to protect an already

treated quadrant from being

cross-contaminated. The patient will be granted

with immediate soothing and pain relief. The

paste is tested for biocompatibility and dissolves

naturally over time.

Phase 2: Patient gum brushing

Unique liquid
brushing solution

Patient Aftercare Dissolve tablet Brush with the
in provided container special solution
Faster healing
Stops bleeding How does the brushing solution help?
Reduces microbial gum infection
Phase 2 of the PerioCream kit is a “Take Home Patient
Phase 2 Kit” given to the patient following the application of
Gum brushing Phase 1. This patient kit contains 10 effervescent tablets
Inflammation to be used to create a liquid brushing solution and a
following SRP specially provided container so that the patient can
measure out the required quantity of water. The
patient is recommended to brush with the solution
daily for 10 days.

The liquid solution has been shown to decrease
healing time, reduce bleeding of the gums, and
reduce the microbial gum infection. This allows for a
powerful and unique aftercare system that differs from
the use of a mouthwash in that it also allows for the
benefits of a mechanical action due to the brushing, as
well as the penetrative action of the liquid formulation.
The formula has also been successfully used in the past
as a powerful anti-biofilm agent on removable dental
appliances under the trade name of NitrAdine®.

Clinical Trial

Multicentre, open label, randomised, clinical study to evaluate and compare the efficacy and safety of PerioCream®, a
Periodontal Paste Dressing and Gum Brushing Solution as an adjunct treatment to scaling and root planing (SRP), with SRP
alone in patients suffering from chronic periodontitis.

Treatment Group: (Patients N=20)
The PerioCream® Periodontal Paste Dressing was applied once over the gums and gingival sulcus for 2-3 hours
immediately after SRP on patients suffering from chronic periodontitis. This was followed by 10 days of brushing with the
PerioCream® Gum Brushing Solution.

Control Group: (Patients N=9)
The Control Group also suffering from chronic periodontitis were treated with SRP only. Both Treatment Group and
Control Group were evaluated at Day 0, Day 5 and Day 11 following onset of the study for the following parameters:

Parameters measured during each evaluation day: Bacterial count of Periodontopathogenic Bacteria:
• Plaque Index (PI) • Prophyrompnas Gingivalis (Pg)
• Gingival Index (GI) • Prevotella intermedoa (Pi)
• Periodontal Bleeding Index (PBI) • Aggregatibacer actinomycetemcomitans (Aa)
• Fusobacterium nucleatum (Fn)

Microbial gum infection over the treatment period Summary of Gingival Index progression
over the treatment period
Control group: 66.7% were infected at the start of the treatment.
Out of these 66.7%, 100% were still infected after 11 days. 1.0 Treatment Group
0.8 Control Group
Percentage of patients
Gingival Index average for group**
Treatment group: 60% were infected at the start of the treatment.
Out of these 60%, only 25% were still infected after 11 days.

100 Treatment Group 0.6
80 Control Group
0.4

60 0.2

40 0.0 Day 0 Day 0 Day 5 Day 11

20 (Before SRP) (After SRP)

0 Percentage of patients Percentage of patients **Gingival Index was assessed using (Loe and Silness; 1963) index
infected at the still infected after system for the assessment of the gingival condition and record
start of treatment 11 days qualitative changes on the gingival. It scores the marginal and
interproximal tissues separately on the basis of 0 to 3.

Clinical Trial

Plaque Index average for group* Summary of Plaque Index progression Periodontal Bleeding Index average for group*** Summary of Periodontal Bleeding Index progression
over the treatment period over the treatment period

2.0 Treatment Group 2.0 Treatment Group
1.5 Control Group 1.5 Control Group

1.0 1.0

0.5 0.5

0.0 Day 0 Day 0 Day 5 Day 11 0.0 Day 0 Day 0 Day 5 Day 11
(Before SRP) (After SRP)
(Before SRP) (After SRP)

*Plaque levels were assessed using the Turkesy modification of ***Periodontal Bleeding Index was measured using Muhleman and
the Quiglet-Hein Plaque Index. Son 1971 score chart, which described the sulcus bleeding.

Percentage of patients experiencing Halitosis sensation after 11 days Between group comparisons indicate that the patients of the
Halitosis Sensation reduction 100 Treatment Group Treatment Group experienced significantly greater
80 Control Group reduction in Plaque Index, Gingival Index and Periodontal
60 Bleeding Index after 11 days. None of the patients from the
40 Treatment Group complained about irritation following
20 application of the PerioCream Periodontal Paste Dressing.

0 Day 11 Application of the PerioCream Periodontal Paste Dressing
significantly reduced the bacterial load of the gums as
compared to Control Group on day 11. A total of 9 out of 11
patients (82 %) in Treatment Group were successfully cured
after 11 days of treatment, whereas in Control Group, none
of the patients were cured after day 11.

After the PerioCream treatment, all patients experienced
reduction in gum pain, dryness sensation, gum or sulcus
bleeding, including symptoms of infection.

In summary, the use of PerioCream treatment as an adjunct to SRP treatment is vastly
beneficial for patients compared to patients receiving SRP treatment only.

www.periocream.com

19.430.00.X.0.0.01 • R27022017D-BJ • 189