Protocol summary

Study aim
Comparative determination of clinical and radiographic outcomes of indirect pulp treatment with silver diamine fluoride and calcium hydroxide in primary teeth
Design
Clinical trial with intervention groups, with parallel groups, triple blind, randomized, phase 2 on 66 patients. Random Allocation Software was used for randomization.
Settings and conduct
Children with indication of indirect pulp treatment referred to pediatric dentistry department are divided into two groups (calcium hydroxide and silver diamine fluoride) and after complete removal of peripheral caries, experimental materials are placed on the remaining caries. Clinical and radiographic symptoms will be checked after 3 and 6 months. The outcome assessor will be a statistical analyst and the patients will be blinded.
Participants/Inclusion and exclusion criteria
3-7-year-old children without systemic disease with Frankel 3 and 4, with large carious lesions, caries close to the pulp, lamina dura, and normal periodontal ligament space, absence of periapical changes and pathological analysis.
Intervention groups
In both groups, a deep injection of local anesthesia is performed. The decay of the outer walls of the cavity is completely removed. In the inner walls, the caries are completely removed and some of the caries remain to prevent pulp exposure. After removing the caries in one group, calcium hydroxide in the deepest part of the cavity, meter is placed. In the other group, silver diamine fluoride is applied to the floor of the cavity. After placing the test material, the tooth is subsequently restored with RMGI to ensure proper flooding in each case, and then the final restoration is done with SSC.
Main outcome variables
Normal gums, no abscess and fistula, no pain in the desired tooth, no internal and external analysis, no expansion of the periodontal ligament space, no furca involvement and no apical lucency.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230530058338N1
Registration date: 2023-06-11, 1402/03/21
Registration timing: prospective

Last update: 2023-06-11, 1402/03/21
Update count: 0
Registration date
2023-06-11, 1402/03/21
Registrant information
Name
Shahram Mosharrafian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 919 857 8366
Email address
shahramosharrafian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2024-05-04, 1403/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of clinical and radiographic outcomes of indirect pulp treatment with silver diamine fluoride versus calcium hydroxide in primary teeth: a randomized controlled clinical trial.
Public title
Pulp effect with silver diamine fluoride and calcium hydroxide in primary teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children without systemic disease who are cooperative according to Frankel classification, Frankel 3 and 4. On clinical examination, large carious lesions involving the occlusal or proximal surfaces, with normal gingival appearance and having at least one decayed deciduous molar on each side of the mandible or maxilla. In the radiographic examination, the observation of caries close to the pulp that involved about two-thirds of the thickness of the dentin, normal lamina dura, normal periodontal ligament space, root length more than two-thirds, absence of periapical changes, absence of external or internal pathological analysis.
Exclusion criteria:
A history of sharp, piercing pulpal pain that persists after removal of the stimulus, as well as spontaneous pain and nocturnal pain Clinical examination showing tooth mobility, tooth discoloration, sinus tract or tooth abscess Radiographic examination showing a carious lesion with intermittent exposure of the pulp, interrupted lamina dura, widening of the periodontal ligament space, periapical radiolucency and internal or external pathological degeneration. Children with absolute sensitivity to any kind of anesthetic
Age
From 3 years old to 7 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Since the two groups are supposed to have the same sample size, limited randomization and block randomization will be used in this study. Random block units will usually be used in order to balance the number of samples allocated to each of the studied groups. The size of the blocks will be chosen randomly and in each block there is an equal number of each group. The way to make the random sequence will be by the computer software "Random Allocation Software". Concealment of random allocation will be done by using opaque sealed and waxed envelopes in a random sequence by an independent person who is not aware of the study process.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The outcome assessor and the statistical analyst will not know about the study groups. In the case of patients, blinding is such that patients do not know which material was used to cover the pulp. In the case of the assessor, the person who completes the study checklist, they do not know the patients group. The data analyst will be blinded and all data will be coded.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of dentistry faculty, Tehran university of medical sciences
Street address
Deputy of Research and Technology of Tehran university of medical sciences, corner of Qods, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416633591
Approval date
2023-06-10, 1402/03/20
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1402.022

Health conditions studied

1

Description of health condition studied
Large caries of primary teeth
ICD-10 code
K08.43
ICD-10 code description
Partial loss of teeth due to caries

Primary outcomes

1

Description
Normal gums
Timepoint
After 3 and 6 months
Method of measurement
Clinical assessment

2

Description
Absence of abscess and fistula
Timepoint
After 3 and 6 months
Method of measurement
Clinical assessment

3

Description
Absence of desired toothache
Timepoint
After 3 and 6 months
Method of measurement
Clinical assessment

4

Description
No internal and external degeneration
Timepoint
After 6 months
Method of measurement
Radiographic evaluation

5

Description
Lack of widening of the periodontal ligament space
Timepoint
After 6 months
Method of measurement
Radiographic evaluation

6

Description
No furca involvement
Timepoint
After 6 months
Method of measurement
Radiographic evaluation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A deep injection of local anesthesia is performed using lidocaine and the tooth is isolated with a cotton roll. The caries removal of the outer walls of the cavity is completely performed by a diamond process bur using a high speed handpiece with plenty of water. In the inner walls, the infected caries are completely removed and some of the affected caries remain to prevent pulp exposure. After removing the caries, in one group, self-cure calcium hydroxide from Dycal Calcium Hydroxide brand (Dentsply sirona-USA)) is placed in the deepest part of the cavity with a minimum thickness of 1.5 mm by using a Dykal applicator.
Category
Treatment - Drugs

2

Description
Intervention group: A deep injection of local anesthesia is performed using lidocaine and the tooth is isolated with a cotton roll. The caries removal of the outer walls of the cavity is completely performed by a diamond process bur using a high speed handpiece with plenty of water. In the inner walls, the infected caries are completely removed and some of the affected caries remain to prevent pulp exposure. After removing the caries, In the other group, SDF Cariestop 30% (Biodinamica-Brazil) was applied to the cavity floor with a microtip applicator.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of pediatric dentistry, Tehran University of Medical Sciences
Full name of responsible person
Shahram Mosharrafian
Street address
Tehran university of medical sciences, corner of Qods, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416633591
Phone
+98 21 8889 6696
Email
shahramosharrafian@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Deputy of Research and Technology of Tehran university of medical sciences, corner of Qods, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416633591
Phone
+98 21 8889 6696
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Shahram Mosharrafian
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Tehran university of medical sciences, corner of Qods, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416633591
Phone
+98 21 8889 6696
Email
shahramosharrafian@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahram Mosharrafian
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Tehran university of medical sciences, corner of Qods, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416633591
Phone
+98 21 8889 6696
Email
shahramosharrafian@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Negar Ziaee
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tehran university of medical sciences, corner of Qods, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416633591
Phone
+98 21 8889 6696
Email
Negar.ziaee2015@gmail.com

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
Not applicable
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