Comparison of clinical retention of fissure sealants with and without using sodium hypochlorite after enamel etching.
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, on 34 patients. A coin was used for randomization.
Settings and conduct
Samples of 34 people in the age group of 7-12 years will be randomly selected from the patients referred to the pediatric dentistry ward. After examination with a catheter and observation and diagnosis of no caries and the presence of deep grooves, one patient's tooth is treated in the usual way and the other tooth is treated with the researched method. Using a coin, one molar will be randomly selected as the control group and one molar as the intervention group; Therefore, for permanent first molars, one side of the fissure sealant is treated in the usual way and for the first permanent molars on the other side of the mandible after acid etching, sodium hypochlorite is applied and then fissure sealant treatment is performed. And 6 months after treatment, patients will be re-examined.
Blinding: The participant will be blind, but due to the nature of the study, the practitioner cannot be blind. Also in the follow-up session, the dentist who is blind to the treatment process will check the sealants.
Participants/Inclusion and exclusion criteria
Presence of any types of dental caries.
Medically compromised patients.
Tooth isolation impossibility.
Lack of cooperation and acceptance from patients or their parents.
Self-cleansing occlusal pits and fissures which did not need fissure sealant therapy.
Intervention groups
In the intervention group, after preparation of tooth enamel with acid etching, sodium hypochlorite will be applied and then fissure sealant will be used.
Main outcome variables
Evaluation of the effect of sodium hypochlorite on fissure sealant's retention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210621051650N1
Registration date:2021-07-05, 1400/04/14
Registration timing:retrospective
Last update:2021-07-05, 1400/04/14
Update count:0
Registration date
2021-07-05, 1400/04/14
Registrant information
Name
Masoumeh Vatandoust
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 9659
Email address
masoomeh.vatandoost@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-31, 1400/03/10
Expected recruitment end date
2021-07-01, 1400/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical retention of fissure sealants with and without using sodium hypochlorite after enamel etching in 7-12 year old children
Public title
Comparison of clinical retention of fissure sealants with and without using sodium hypochlorite after enamel etching
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Participants should have had cooperation and acceptance for dental treatment and good oral hygiene.
Patients with a pair of sound first permanent mandibular molars, bilaterally, which were qualified for fissure sealant therapy.
Ages between 7 and 12 years.
Teeth should have had acceptable situation for isolation with cotton roll and suction.
Exclusion criteria:
Presence of any types of dental caries.
Medically compromised patients.
Tooth isolation impossibility.
Lack of cooperation and acceptance from patients or their parents.
Self-cleansing occlusal pits and fissures which did not need fissure sealant therapy.
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
37
More than 1 sample in each individual
Number of samples in each individual:
2
A pair of sound first permanent mandibular molars, bilaterally, which were qualified for fissure sealant therapy.
Randomization (investigator's opinion)
Randomized
Randomization description
Using a coin, one molar will be randomly selected as the control group and one molar as the intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant will be blind, but due to the nature of the study, the practitioner cannot be blind. Also in the follow-up session, the dentist who is blind to the treatment process will check the sealants.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
No. 45, Golha Alley, North shahriyar Ave, Valiasr Town
City
Tabriz
Province
East Azarbaijan
Postal code
5157838464
Approval date
2021-05-31, 1400/03/10
Ethics committee reference number
IR.TBZMED.REC.1400.258
Health conditions studied
1
Description of health condition studied
Comparison of clinical retention of fissure sealants with and without using sodium hypochlorite after enamel etching
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The percentage of people in whom fissure sealant retention is increased by the use of sodium hypochlorite.
Timepoint
Measurement of fissure sealant retention rate six months after treatment.
Method of measurement
After 6 months, all 34 people will be contacted in order of fissure sealant time and in the pediatric ward of the faculty will be checked by 2 pediatric dentists. The reliability of the examiners will be calculated using Cohen's Kappa statistical coefficient. Each fissure sealant will be evaluated independently using a mirror and a slow catheter after 6 months by 2 calibrated researchers, who were not involved in the treatment process. If there is a disagreement between the two researchers during the evaluation period, after discussion, an agreement will be reached. If the treatment fails, the tooth will be re-treated. The examination technique will be visual observation and clinical evaluation.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Preparation of permanent mandibular first molar enamel with acid etching (usual method) and use of fissure sealant.
Category
Prevention
2
Description
Intervention group: Preparation of enamel with acid etch then apply cotton impregnated with 5.25% sodium hypochlorite and use fissure sealant.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Leila Erfanparast
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz Dental School, Golgasht Ave, Daneshgah Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
+98 41 3334 6977
Email
leilaerfan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Erfanparast
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz Dental School, Golgasht Ave, Daneshgah Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
+98 41 3334 6977
Email
leilaerfan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Erfanparast
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz Dental School, Golgasht Ave, Daneshgah Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
+98 41 3334 6977
Email
leilaerfan@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data potentially shareable after unidentifiable individuals
When the data will become available and for how long
Access starts six months after the start of the research and the preparation of the preliminary results.
To whom data/document is available
All researchers who are interested in the subject and want to do similar research.
Under which criteria data/document could be used
It can be used to perform similar research through the intended process.
From where data/document is obtainable
leilaerfan@gmail.com ahankhah_saina@yahoo.com : Researchers who want to access the data can contact these emails or the mobile number : 09146307969.
What processes are involved for a request to access data/document
The applicant can access the data after the end of the study (about six months after the treatment) by sending an email to the scientific director of the study or by phone and explaining the reason for obtaining the data.