Comparative evaluation of the efficacy of calcium hydroxide with resin modified glass ionomer versus TheraCal in indirect pulp cap in teeth with deep caries: a clinical trial study
Determining the efficacy of TheraCal versus calcium hydroxide in indirect pulp cap
Design
A clinical trial with a control group, double blind, the number of 50 selected patients in two treatment groups with an equal number and randomization by permutation blocks using Allcation Random software.
Settings and conduct
This study will be a double-blind clinical trial (both for patients and statistical analysts) and will examine 50 patients referred to Shahrekord dental school and office.
The patients will not know about the content of the received intervention and the statistical analyst will not know about the content of the information file that will be provided in the form of groups A and B.
Patients will be randomly divided into two groups with equal numbers: Group A: treated with Calcium Hydroxide Self-Cure and Liner Hybrid Ionomer Light Cure and Group B: treated with TheraCal LC. Clinical examinations to check pain after treatment in the follow-up period of the patient in 21 days, three months and six months after treatment and if there are clinical symptoms, radiographic examination will be done to check periodontal ligament(PDL) space six months after treatment.
Participants/Inclusion and exclusion criteria
Patients referring to Shahrekord dental school and office
- Criteria for entering the study
1. Patients with mature permanent teeth
2. Patients with caries in the dentin more than one-half or three-quarters of the thickness of the dentin
3. Patients with reversible pulpitis
- Exclusion criteria
1. Patients with irreversible pulpitis
2. Tooth with necrotic pulp
Intervention groups
Group A: people treated with self-cure calcium hydroxide and light cure hybrid ionomer liner, and group B: people treated with TheraCal
Comparative evaluation of the efficacy of calcium hydroxide with resin modified glass ionomer versus TheraCal in indirect pulp cap in teeth with deep caries: a clinical trial study
Public title
Comparative evaluation of the efficacy of calcium hydroxide with resin modified glass ionomer versus TheraCal in indirect pulp cap: a clinical trial study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mature permanent teeth with closed apex
Patients with caries in the dentin more than one-half or three-quarters of the thickness of the dentin
Patients with reversible pulpitis
Dental samples must respond positively to the cold test
Exclusion criteria:
Patients with irreversible pulpitis
Teeth with internal and external absorption
Tooth with periapical lesion
Tooth with necrotic pulp
Cracked teeth
People with periodontitis
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method of replacement blocks will be used with the size of each block equal to 6. The randomization list will be prepared by the permutation block method using Allcation Random software and will be provided to the researcher.
Blinding (investigator's opinion)
Double blinded
Blinding description
This clinical trial study will be conducted in a double-blind manner so that both the patients participating in the study and the statistical analyst will be blinded.
Blinding for the patients will be in such a way that theracal and calcium hydroxide materials have similar colors and the patients will not have any information about the content of the received intervention.
Also, the information file will be provided to the statistical analyst in the form of group A and group B, and this person will not have any information about the content of the intervention of groups A and B, which will cause all the results to be analyzed based on groups A and B and will be provided to the main researcher.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine - Shahrekord University of Medical Sciences
Street address
Fadak complex,Hamedanian St.,East Haht Behesht St.
City
Isfahan
Province
Isfehan
Postal code
8157967764
Approval date
2023-09-13, 1402/06/22
Ethics committee reference number
IR.SKUMS.MED.REC.1402.048
Health conditions studied
1
Description of health condition studied
Indirect pulp capping for teeth with deep decay
ICD-10 code
K02.1
ICD-10 code description
Caries of dentine
Primary outcomes
1
Description
The degree of pain or clinical sensitivity
Timepoint
21 days, three months and six months after treatment
Method of measurement
Based on the Numeric Rating Scale
2
Description
Vitality of the pulp or Vitality of the dental nerve, which is determined by the feeling of cold or heat after performing vitality tests
Timepoint
21 days, three months and six months after treatment
Method of measurement
Vitality tests (cold and heat test)
3
Description
Widening of the periodontal ligament space around the apex in radiographs
Timepoint
6 months after treatment in case of pain and clinical sensitivity
Method of measurement
Radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People treated with TheraCal : For both intervention and control groups, local anesthesia, isolation of the investigated tooth and selective removal of caries are performed. The tooth is disinfected with chlorhexidine 2% and rinsed with normal saline. Then the teeth are randomly divided into two groups: the intervention group consists of 25 teeth and will be treated with TheraCal LC (calcium silicate liner modified with light cure resin): the material is applied to the deepest points of the cavity floor and It is then light cured according to the manufacturer's instructions. TheraCal LC from Bisco is supplied by the manufacturer as a disposable syringe and syringe head and does not require preparation before use.
Category
Treatment - Other
2
Description
Control group: people treated with self cure calcium hydroxide (Dycal) and light cure hybrid ionomer liner: Dycal is available as a two-paste system (a catalyst paste and a base paste). Equal amounts of catalyst and base are mixed and applied with a Dycal applicator directly to the deepest points of dentin in the cavity. Excess Dycal material will be removed from the cavity walls and enamel margins. Then Light Cure glass ionomer cement is placed in the cavity as a base.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord Faculty of Dentistry
Full name of responsible person
Mitra Yadolahi
Street address
Faculty of Dentistry, Resalat Square, Rahbar Blvd.,Chaleahtor
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۵۱۶۷۸۹۷۱
Phone
+98 38 3232 2400
Email
khorshid_mohammad@yahoo.com
2
Recruitment center
Name of recruitment center
Dental office of Dr. Mitra Yadalhi
Full name of responsible person
Mitra Yadolahi
Street address
Parsian Building, Enghelab Sq.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815938711
Phone
+98 38 3333 8388
Email
yadollahi.mitra@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Elham Raeisi
Street address
Building no2,University Headquarters,Kashani Boulevard
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 2414
Email
vcrt@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
The clinical study report will be published as an article
When the data will become available and for how long
It is possible to start accessing immediately after printing the results
To whom data/document is available
Access is open to the public
Under which criteria data/document could be used
For more information
From where data/document is obtainable
Fadak Complex, Hamedanian St. ,Hasht Behesht St. ,Isfahan
Shamim Mohammadi
khorshid_mohammad@yahoo.com
09134432263
What processes are involved for a request to access data/document
The clinical study report will be available to the public immediately after printing. For detailed information, send an email to
khorshid_mohammad@yahoo.com.
The data files will reach the applicant after 1 month.