Comparing The Effect of Propolis Extract and Chlorhexidine Mouthwash on Clinical Parameters and Salivary Level of Matrix Metalloproteinase 8 in Chronic Periodontitis Patients: A Randomized Controlled Clinical Trial
This study aimed to compare the efficacy of Propolis Extract and Chlorhexidine Mouthwash in chronic periodontitis patients. This phase 3 RCT will be conducted on 24 patients presented to Tehran University of Medical Sciences, School of Dentistry, International Campus, in the age range of 25 to 50 years with deep pockets (≥5 mm) around a minimum of three teeth.The exclusion criteria are presence of periapical changes in the respective teeth, systemic conditions requiring antibiotic prophylaxis or affecting the progression of disease or response to treatment. The patients will be randomly divided into two groups of propolis and chlorhexidine. Patients in chlorhexidine group undergo SRP and using 0.2 % chlorhexidine mouthwash twice a day for two weeks. In the propolis group, SRP will be performed followed by irrigation with 3 cc of hydroalcoholic solution of propolis extract twice a week for two weeks. Clinical parameters including gingival index (GI), bleeding on probing (BOP), pocket probing depth (PPD) and clinical attachment level (CAL) will be measured at baseline (onset of treatment) and one month after treatment. Saliva samples will be collected at baseline and one month later to evaluate the salivary level of Matrix Metalloproteinase 8 using ELISA.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122030475N3
Registration date:2017-02-02, 1395/11/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-02, 1395/11/14
Registrant information
Name
Mitra Askari
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5585 1131
Email address
m-askari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of International Campus, Tehran University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-05-19, 1396/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing The Effect of Propolis Extract and Chlorhexidine Mouthwash on Clinical Parameters and Salivary Level of Matrix Metalloproteinase 8 in Chronic Periodontitis Patients: A Randomized Controlled Clinical Trial
Public title
Effect of Propolis Extract on Chronic Periodontitis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Chronic periodontitis patients; The age range of 25 to 50 years; Having deep periodontal pockets (≥5 mm) around a minimum of three teeth not adjacent to each other.
Exclusion criteria: Presence of periapical changes in the respective teeth; Systemic conditions requiring antibiotic prophylaxis or affecting the progression of disease or response to treatment; History of periodontal therapy in the past six months; Use of antibiotics, Anti-inflammatory drugs, anticonvulsants, immunosuppressive drugs or calcium channel blockers in the past three months; Pregnancy; Orthodontic treatment; Smoking; Having pacemaker; Mitral valve prolapse, Use of mouthrinses during treatment.
Age
From 25 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
For the purpose of randomization, in every 10 patients, 10 envelops will be allocated; out of which, five containing propolis extract and the remaining five containing chlorhexidine mouthwash. By doing this, patients will be randomly divided into test propolis and chlorhexidine groups. After completion of randomization of the first 10 patients, this procedure will be repeated.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of International Campus, Tehran University of Medical Sciences
Street address
Mahan street, Zamzam street, khaniabade no, Navvab highway, Tehran.
City
Tehran
Postal code
Approval date
2015-11-02, 1394/08/11
Ethics committee reference number
IR.TUMS.REC.1394.1066
Health conditions studied
1
Description of health condition studied
Chronic periodontits
ICD-10 code
K05.3
ICD-10 code description
chronic pericoronitis Periodontitis: NOS complex simplex
Primary outcomes
1
Description
Clinical Attachment level (CAL)
Timepoint
Before intervention and one month later
Method of measurement
mm using periodontal probe
2
Description
Pocket Depth (PD)
Timepoint
Before intervention and one month later
Method of measurement
mm using periodontal probe
3
Description
Bleeding on probing (BOP)
Timepoint
Before intervention and one month later
Method of measurement
positive or negative, using periodontal probe
4
Description
Gingival index (GI)
Timepoint
Before intervention and one month later
Method of measurement
Average number of teeth with positive bleeding on probing, using periodontal probe
5
Description
Matrix Metalloproteinase 8 level of saliva
Timepoint
Before intervention and one month later
Method of measurement
Pg/ml, ELISA TEST
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:
In this group, after SRP, the respective areas will be irrigated with 3cc of hydro-alcoholic solution of propolis extract 20 % (Soren Tech, Mashhad, Iran) twice a week for two weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2:
In this group, after SRP, 0.2 % chlorehexidine mouthwash (Shahredaru, Tehran, Iran) is prescribed for use twice a day for two weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, International Campus, Tehran University of Medical Sciences.
Full name of responsible person
Street address
Mahan street, Zamzam street, khaniabade no, Navvab highway, Tehran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of International Campus, Tehran University of Medical Sienses.
Full name of responsible person
Mitra Montazerlotf
Street address
Mahan street, Zamzam street, khaniabade no, Navvab highway, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of International Campus, Tehran University of Medical Sienses.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Dentistry, International Campus, Tehran University of Medical Sciences.
Full name of responsible person
Reyhane Eghbali Zarch
Position
Dentistry student
Other areas of specialty/work
Street address
Mahan street, Zamzam street, khaniabade no, Navvab highway, Tehran.
City
Tehran
Postal code
Phone
+98 21 5585 1131
Fax
Email
reiihane@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry, International Campus, Tehran University of Medical Sciences.
Full name of responsible person
Mitra Askari
Position
Assistant Professor
Other areas of specialty/work
Street address
Mahan street, Zamzam street, khaniabade no, Navvab highway, Tehran.
City
Tehran
Postal code
Phone
+98 21 5585 1131
Fax
Email
askari_mitra@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Dentistry, International Campus, Tehran University of Medical Sciences.
Full name of responsible person
Mitra askari
Position
Assistant Professor
Other areas of specialty/work
Street address
Mahan street, Zamzam street, khaniabade no, Navvab highway, Tehran.
City
Tehran
Postal code
Phone
+98 21 5585 1131
Fax
Email
Askari_mitra@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)