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CTRI Number  CTRI/2014/08/004912 [Registered on: 22/08/2014] Trial Registered Prospectively
Last Modified On: 31/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   Clinical study to reduce the gum problem with use of cream and brushing solution. 
Scientific Title of Study   A Multicenter, Open Label, Randomized, Clinical Study to evaluate and Compare the Efficacy and Safety of Gingivial Paste (Periocream) and Brushing Solution manufactured by Bonyf AG as an adjunct to scaling and roots planning (SRP) with SRP alone in subjects suffering from chronic periodontitis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ECTS/14/003, Version No. 00, Dated 28 JUL 2014  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Milan Satia 
Designation  Chief Executive Officer 
Affiliation  Ethicare Clinical Trial Services 
Address  410 to 412, G - Block, Titanium City Centre, 100 Feet Road, Nr. Sachin Tower, Satellite

Ahmadabad
GUJARAT
380015
India 
Phone  09825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Milan Satia 
Designation  Chief Executive Officer 
Affiliation  Ethicare Clinical Trial Services 
Address  410 to 412, G - Block, Titanium City Centre, 100 Feet Road, Nr. Sachin Tower, Satellite


GUJARAT
380015
India 
Phone  09825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Details of Contact Person
Public Query  
Name  Dr Milan Satia 
Designation  Chief Executive Officer 
Affiliation  Ethicare Clinical Trial Services 
Address  410 to 412, G - Block, Titanium City Centre, 100 Feet Road, Nr. Sachin Tower, Satellite


GUJARAT
380015
India 
Phone  09825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Source of Monetary or Material Support  
Bonyf AG 
 
Primary Sponsor  
Name  Bonyf AG 
Address  Heiligkreuz 16, FL-9490 Vaduz Principality of Liechtenstein EEA (European Economic Area) 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bela Dave  AMC Dental College  2nd Floor, Department of Periodontia, Opp. Anupam Cinema, Bhalakiya Mill Compound, Khokhara
Ahmadabad
GUJARAT 		 09979667676

beladeve@gmail.com 
Dr Viral Patel  College of Dental Sciences & Research centre  Dept. No.3, Dept. of periodontiia, College of Dental Sciences & Research centre, Opp.Pleasure club, Near Bopal, Manipur
Ahmadabad
GUJARAT 		 09825060235

drviralpatel@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee of AMC Dental College  Not Applicable 
Sangini Hoapital Ethics Committee For Dr Viral Patel  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Chronic Periodontitis who need Scaling and Root planning, (1) ICD-10 Condition: K054||Periodontosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Gingival Paste (PerioCream) and Brushing Solution  Gingival paste is applied once time as a coating over infected or healthy gums for 2-3 hours directly after treatment following SRP treatment. For Brushing solution dissolve 1 brushing tablet in 15 ml of luke warm water in given container brush teeth and gums for 2 to 3 minutes using the solution. 
Comparator Agent  Nil  Control Group will only have SRP treatment. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Male or female subjects with 30-50 years of age (both inclusive).
2. Subjects suffering from chronic periodontitis and required medical device after scaling and root planning (SRP) in Non-chirurgical procedures.
3. Negative history of any systemic disease.
4. Willingness to comply with the study schedule and procedures. 
 
ExclusionCriteria 
Details  1. Subjects with a history of allergy for content present in “PerioCream”.
2. Subjects with Mobile, carious, endodontically treated teeth.
3. History of chronic liver disease, chronic renal disease, diabetic, Hyperthyroidism, severe anaemia, severe myasthenia, Active haemorrhage, Acute alcohol intoxication, Recent myocardial infarction).
4. Smokers and Tobacco users.
5. Subjects using any chemical plaque inhibitors.
6. Subjects suffering from condition requiring antibiotics prior to dental procedures or currently using antibiotics, anticoagulants, steroids, or any other medication which could alter the oral microflora.
7. Participation in any other clinical study during last 30 days.
8. Subject with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
9. Subject is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period, or is breast feeding. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
•Tolerance based on clinical dermatological and dental criteria of the paste and tablets (irritation to mucus membrane)
•Efficacy of brushing small tabs (considering oral Hygiene product) by determining Plaque index, gingival index, periodontal bleeding index and clinical attachment level.
•Total bacterial count and analysis (before and after treatment with periocream)
•Evaluation will be done on bases of questionnaire. 		 10 days 
 
Secondary Outcome  
Outcome  TimePoints 
Spontaneously reported and directly observed Adverse Events after first dose until End of treatment visit.  10 Days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "29"
Final Enrollment numbers achieved (India)="29" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   26/08/2014 
Date of Study Completion (India) 30/09/2014 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   A Multicenter, Open Label, Randomized, Clinical Study To Evaluate and Compare The Efficacy And Safety of Gingivial paste (Periocream) and brushing solution an adjunct to scaling and roots planning (SRP) with SRP alone in subjects suffering from chronic periodontitis. Gingival  paste composed of Calcium/ Sodium PVM/MA copolymer and Olive Oil is applied once time as a coating over infected or healthy gums for 2-3 hours directly after treatment following SRP treatment. On next day 10 effervescent brushing tablets and container given to subjects along with instruction sheet with which subject have to brush their teeth. Clinical periodontal parameter & Clinical Performance parameter will be checked before and after treatment. Also Subgingingival plaque will be collected, pre and post treatment, for total bacterial count and analysis of four major periodontopathogenic bacteria. Data will be compare with control group subject who only had SRP treatment.

 
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