Evaluation of the effect of topical administration (mouthwash) of capsuls containing probiotics in the treatment of patients with pre-implantitis (clinical trial)
The aim is to compare the improvement of patients with pre-implantitis after scaling and taking probiotic tablets as a mouthwash with patients with pre-implantitis after scaling and taking placebo as mouthwash.
Design
randomized trial with blinded postoperative care and outcome assessment and patient design of 70 patient
Settings and conduct
In the specialized dental clinic, after measuring the depth of the envelope and bleeding during the probe around the implant, if it has pre-implantitis conditions ,scaling is performed, it is divided into two groups, one capsule containing probiotics and the other group is given a placebo. 0-14-30days after the first examination, they are reviewed. In this study, the patient measuring and analyzer are blinded Blocked method
Participants/Inclusion and exclusion criteria
age 30-60
peri-implantitis index
do not allergy to probiotic
Intervention groups
The intervention group received 14 capsules containing probiotics, which dissolved one capsule in two tablespoons of lukewarm water every night and used as a mouthwash for 14 nights.
The control group receiving placebo 14 capsules is a form of placebo that dissolves one capsule in two tablespoons of lukewarm water every night and uses it as a mouthwash for 14 nights.
Main outcome variables
depth of packet around implant
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190101042195N1
Registration date:2020-10-28, 1399/08/07
Registration timing:registered_while_recruiting
Last update:2020-10-28, 1399/08/07
Update count:0
Registration date
2020-10-28, 1399/08/07
Registrant information
Name
Farzane Eivani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3881 7458
Email address
eivani.farzane@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-10, 1399/06/20
Expected recruitment end date
2020-11-10, 1399/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of topical administration (mouthwash) of capsuls containing probiotics in the treatment of patients with pre-implantitis (clinical trial)
Public title
Effect of Probiotic in treatment of peri--implantitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30-60 years
Preimplantitis index
Do not allergy to probiotics
Exclusion criteria:
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Block
This method is used to prevent eye imbalance in the number of manufacturing companies that are assigned to each group. Block liquidation ensures that it is not approved at any time during the refund period, but can not be validated in other power groups, and if some of the companies in each group are equal, this method requires that each block be specified. (Types of quadruple blocks). Then write the list of blocks and assign the numbers (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6) after selecting random numbers between one and 6 (Eg 1 4 5, etc.) and finally it is determined that it cures the specified list before (ad AABB-BBAA-BABA-).}
The concealment is sealed envelope
Blinding (investigator's opinion)
Triple blinded
Blinding description
Origin researcher and analyzer and patient are unaware of control and intervention groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad Dentistry School,Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2020-06-27, 1399/04/07
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1399.014
Health conditions studied
1
Description of health condition studied
Peri-implantitis
ICD-10 code
K05.6
ICD-10 code description
Diseases of oral cavity, salivary glands and jaws, Periodontal disease, , unspecified
Primary outcomes
1
Description
Measure the depth of the pocket around the implant
Timepoint
Measure the depth of the pocket at the beginning of the study and 14,30 days after the start of probiotic use
Method of measurement
probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients are scaled and given capsules of a pre-coded form (for two weeks and once a day). The intervention group is given 14 capsules containing probiotics, brand Gerilact. every night Dissolve one capsule in two tablespoons of warm water and hold it in the mouth as a mouthwash for one to two minutes and then take it out. Patients are re-evaluated after the first examination, 14 days after the first examination and 30 days after the first examination.
Category
Treatment - Drugs
2
Description
Control group: Patients are scaled and 14 capsules of one form and pre-coded placebo are given for two weeks and once a day. Every night, the contents of one capsule are dissolved in two tablespoons of lukewarm water and mouthwash for one to two minutes and then taken out. 14 days and 30 days after the first examination ,Will be re-evaluated
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Dental School
Full name of responsible person
Naser Sargolzaei
Street address
Mashhad Dental School, Vakilabad Blvd,
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7000
Email
j.m.dental.s@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Bagherih
Street address
Mashhad Dental School, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7000
Email
j.m.dentistry@yahoo.com
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Naser Sargolzaei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental School , Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7000
Email
sargolzaein@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Naser Sargolzaei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental School , Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7000
Email
sargolzaein@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Naser Sargolzaei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental School , Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7000
Email
sargolzaein@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available