Evaluation of topical formulation (mouthwash) containing Zingiber officinalis, Rosmarinus officinalis and Calendula officinalis efficiency in patients with gingivitis
Objectives: Evaluation of topical formulation (mouthwash) containing Zingiber officinalis, Rosmarinus officinalis and Calendula officinalis efficiency in patients with gingivitis. Design: randomized, double-blind, placebo-controlled, single center, second phase clinical trial. Study groups: patients with mild to moderate gingivitis. Sample size: 60 patients divided equally in the treatment group, placebo group and positive-control group. Inclusion criteria: patients with gingivitis; having at least 18 natural teeth; MGI scores between 1.3-2.75; MQH scores of at least 1.5. Exclusion criteria: requirement of antibiotic therapy for treatment of gingivitis; using antibiotics for at least 14 days before and after the study; using anti-inflammatory drugs during the study; using anticoagulation drugs during the study; using immunosuppressive drugs; patients under 18 or over 65; pregnancy and lactation. Intervention: a mouthwash containing the extract of Zingiber officinalis, Rosmarinus officinalis and Calendula officinalis is used in patients with mild to moderate gingivitis. In the placebo group a similar mouthwash without the herbal extracts is used. In the positive-control group Chlorhexidine 0.2% mouthwash is used. This study is carried out in a 2 week period and the scores are evaluated each week by the dentist. Primary outcome variable: Modified Gingival Index (MGI). Secondary outcome variables: Gingival Bleeding Index (GBI); Modified Quigley- Hein Plaque Index (MQH).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015070523078N1
Registration date:2015-08-31, 1394/06/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-31, 1394/06/09
Registrant information
Name
Saman Mahyari
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 4589
Email address
mahyaris891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-09-01, 1394/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of topical formulation (mouthwash) containing Zingiber officinalis, Rosmarinus officinalis and Calendula officinalis efficiency in patients with gingivitis
Public title
Effect of the extract of Rosmarinus officinalis, Zingiber officinalis and Calendula officinalis on gingivitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with gingivitis; having at least 18 natural teeth; MGI scores between 1.3-2.75; MQH scores of at least 1.5. Exclusion criteria: requirement of antibiotic therapy for treatment of gingivitis; using antibiotics for at least 14 days before and after the study; using anti-inflammatory drugs during the study; using anticoagulation drugs during the study; using immune-suppressive drugs; advanced gum diseases; patients under 18 or over 65; Sjogren's Syndrome; orthodontic disease; pregnancy and lactation.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee on Medical Research Ethics
Street address
Ghoraishy building, Daneshgah St.
City
Mashhad
Postal code
Approval date
2015-05-04, 1394/02/14
Ethics committee reference number
IR.MUMS.REC.1394.40
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
K05.1
ICD-10 code description
Gingivitis (chronic)
Primary outcomes
1
Description
Modified Gingival Index (MGI)
Timepoint
At the beginning of study, seventh day and fourteenth day
Method of measurement
Observation and Evaluation
Secondary outcomes
1
Description
Gingival Bleeding Index (GBI)
Timepoint
At the beginning of study, seventh day and fourteenth day
Method of measurement
Observation and evaluation
2
Description
Modified Quigley- Hein Plaque Index (MQH)
Timepoint
At the beginning of study, seventh day and fourteenth day
Method of measurement
Observation and evaluation
Intervention groups
1
Description
Herbal mouthwash: Mouthwash formulation of Zingiber officinalis, Rosmarinus officinalis and Calendula officinalis's extract, for each patient 10 milliliters twice a day for two weeks.
Category
Treatment - Drugs
2
Description
Placebo mouthwash: Mouthwash formulation similar to treatment group, but without the extracts of Zingiber officinalis, Rosmarinus officinalis and Calendula officinalis, for each patient 10 milliliters twice a day for two weeks.
Category
Treatment - Drugs
3
Description
Positive-control: Chlorhexidine 0.2 % mouthwash, for each patient 10 milliliters twice a day for two weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pharmaceutical Sciences Research Center
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Saman Mahyari
Position
Pharm D student
Other areas of specialty/work
Street address
School of Pharmacy, Mashhad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 3882 4589
Fax
Email
mahyaris891@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir Hooshang Mohammadpour
Position
PhD
Other areas of specialty/work
Street address
School of Pharmacy, Mashhad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 915 316 2909
Fax
Email
mohamadpoorAH@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saman Mahyari
Position
Pharm D student
Other areas of specialty/work
Street address
School of Pharmacy, Mashhad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 3882 4589
Fax
Email
mahyaris891@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)