Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001513707
Ethics application status
Approved
Date submitted
16/10/2022
Date registered
6/12/2022
Date last updated
6/12/2022
Date data sharing statement initially provided
6/12/2022
Date results information initially provided
6/12/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Calcium Hydroxide, Triple Antibiotic Paste and Chlorhexidine on pain in teeth with Symptomatic Apical Periodontitis
Scientific title
The Effect of Calcium Hydroxide, Triple Antibiotic Paste and Chlorhexidine on Pain in Teeth with Symptomatic Apical Periodontitis: A Randomised Controlled Trial
Secondary ID [1] 308197 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptomatic Apical Periodontitis 327942 0
Condition category
Condition code
Oral and Gastrointestinal 325008 325008 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group-1: Received Calcium Hydroxide paste (20%) as intra-canal medicament; Group-2: Received Chlorhexidine gel (2%) gel; Group-3: Received Tri Antibiotic Paste (ciprofloxacin, minocycline, and metronidazole mixture in proportion of 1:1:1 by weight to the final concentration of 0.5 mg/ml)
All the aforementioned three interventions will be administered as intra-canal medicaments.
The amount of the Calcium hydroxide paste, Chlorhexidine gel, and Tri-antibiotic paste administered is directly proportional to the volume of the intra-canal spaces of the teeth and is typically 0.5-1 ml.
The interventions will be administered by the endodontist only once after the completion of cleaning and shaping stage of the root canal treatment procedure. The approximate duration of the procedure will be one hour.
Intervention code [1] 324650 0
Treatment: Drugs
Comparator / control treatment
Group-4: No medication will be placed after cleaning and shaping procedure
Control group
Active

Outcomes
Primary outcome [1] 332826 0
Post-root canal preparation pain assessed using the Wong-Baker’s FACES Pain Rating Scale
Timepoint [1] 332826 0
at 0, 4, 48 (Primary end point), 72, 96 hours, postoperatively
Secondary outcome [1] 414805 0
Nil
Timepoint [1] 414805 0
Nil

Eligibility
Key inclusion criteria
The inclusion criteria were single rooted teeth (anterior and posterior) with symptomatic apical periodontitis and negative response to vitality testing indicating necrotic pulp
Minimum age
16 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
non-restorable teeth and teeth having endo-perio lesions, acute or chronic apical abscess, chronic periodontitis or anatomical difficulties like open apices, calcified canals, severe dilacerations, internal/ external root resorption and occlusal interferences were excluded from the study. Additionally, allergic patients, patients taking medicines that could influence pain perception or having serious medical illness, systemic disorders, or immunocompromised diseases like AIDS, HBV were also excluded

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The participants were randomly assigned four groups according to simple random number table available online (www.random.org) by an independent operator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analysis was done using SPSS version 24 (IBM, Armonk, NY, USA). ANOVA test was used and Tukey’s posthoc test was utilized to perform the multiple comparisons of pain reduction values between different groups. The level of significance was set at less than 0.05. Lastly, all the experimental groups were compared with the control group by using Dunnett’s test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2021
Date of last participant enrolment
Anticipated
Actual
30/04/2022
Date of last data collection
Anticipated
Actual
4/05/2022
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 25066 0
Saudi Arabia
State/province [1] 25066 0
Qassim

Funding & Sponsors
Funding source category [1] 312453 0
University
Name [1] 312453 0
Qassim University
Country [1] 312453 0
Saudi Arabia
Primary sponsor type
University
Name
Qassim University
Address
Buraydah 52571, Qassim, Saudi Arabia
Country
Saudi Arabia
Secondary sponsor category [1] 314031 0
None
Name [1] 314031 0
None
Address [1] 314031 0
NOne
Country [1] 314031 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311798 0
Dental Ethics Committee, College of Dentistry, Qassim University
Ethics committee address [1] 311798 0
PO Box 6688, Buraydah City 52571, King Abdulaziz Road, Emirate of Qassim, Saudi Arabia
Ethics committee country [1] 311798 0
Saudi Arabia
Date submitted for ethics approval [1] 311798 0
16/11/2017
Approval date [1] 311798 0
23/02/2018
Ethics approval number [1] 311798 0
EA/6008/2018

Summary
Brief summary
The study hypothesis was that "" The placement of different medications after cleaning the teeth will reduce the pain after the procedure in comparison to the teeth where no teeth where no medication was placed after tooth cleaning. The study aimed to assess the efficacy of three intra-canal medicaments on post root canal preparation pain. Eighty patients with single rooted necrotic teeth and symptomatic apical periodontitis were randomly assigned four treatment groups (n=20). The preoperative pain was recorded on Wong-Baker’s FACES Pain Rating Scale. After chemo-mechanical canal preparation intracanal medications were placed: Group-1 (20%calcium hydroxide), Group-2 (2%Chlorhexidine), Group-3 (Tri-antibiotic paste), Group-4 (no medication-control group). Patients were instructed to record pain on Wong-Baker’s FACES Pain Rating Scale at 4, 48,72 and 96 hours, postoperatively
Trial website
Trial related presentations / publications
Public notes
None

Contacts
Principal investigator
Name 122406 0
A/Prof Asma Munir Khan
Address 122406 0
College of Dentistry, Qassim University, PO Box 6688, Buraydah City 52571, King Abdulaziz Road, Emirate of Qassim, Saudi Arabia
Country 122406 0
Saudi Arabia
Phone 122406 0
+966597472235
Fax 122406 0
Email 122406 0
dr.asma.munir@qudent.org
Contact person for public queries
Name 122407 0
A/Prof Muhammad Qasim Javed
Address 122407 0
College of Dentistry, Qassim University, PO Box 6688, Buraydah City 52571, King Abdulaziz Road, Emirate of Qassim, Saudi Arabia
Country 122407 0
Saudi Arabia
Phone 122407 0
+966544788659
Fax 122407 0
Email 122407 0
dr.qasim.javed@qudent.org
Contact person for scientific queries
Name 122408 0
A/Prof Muhammad Qasim Javed
Address 122408 0
College of Dentistry, Qassim University, PO Box 6688, Buraydah City 52571, King Abdulaziz Road, Emirate of Qassim, Saudi Arabia
Country 122408 0
Saudi Arabia
Phone 122408 0
+966544788659
Fax 122408 0
Email 122408 0
dr.qasim.javed@qudent.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As per the instructions of ethical committee the data will be kept in the password protected computer in the department. Only the principal investigator and the person who will analyzed the data has an access to the data. Considering this the patient data can't be shared.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Effect of Calcium Hydroxide, Triple Antibiotic Paste and Chlorhexidine on Pain in Teeth with Symptomatic Apical Periodontitis: A Randomised Controlled Trial.2023https://dx.doi.org/10.3390/ijerph20043091
N.B. These documents automatically identified may not have been verified by the study sponsor.