Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001350718
Ethics application status
Approved
Date submitted
26/08/2022
Date registered
20/10/2022
Date last updated
20/10/2022
Date data sharing statement initially provided
20/10/2022
Date results information initially provided
20/10/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the effect of two intermediate root canal medicaments; Calcium hydroxide and Triple antibiotic paste in the treatment of Extra oral sinus tract and external root resorption
Scientific title
Comparison of efficacy of calcium hydroxide and Triple antibiotic paste in the treatment of Oral cutaneous sinus tract and external root resorption; a randomized clinical trial in patients reported to a tertiary hospital
Secondary ID [1] 307851 0
None
Universal Trial Number (UTN)
Trial acronym
OCST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral cutaneous sinus tract 327463 0
External root resorption 327712 0
Condition category
Condition code
Oral and Gastrointestinal 324589 324589 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Alternative and Complementary Medicine 324590 324590 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Calcium Hydroxide was used for the treatment of Oral cutaneous sinus tract and external root resorption, ,as an intra canal dressing because of strong alkaline nature which raises the pH of root canal and kills the intra canal microbes. 1ml of paste was formed by mixing 10mg of calcium hydroxide with sterile water to form a 1% calcium hydroxide paste. The paste was packed in the root canal immediately after root canal preparation with Gutta percha point by single qualified dentist at Operative department, Rawal hospital, Islamabad. The 1st treatment session was about 60 minutes which included root canal preparation and disinfection with Sodium hypochlorite. Later the canal was packed with calcium hydroxide paste for 3 weeks. The frequency of administration of calcium hydroxide packing was once in 3 weeks. When sinus tract healed, the disinfectant was washed with Sodium hypochlorite irrigation manually and the canal was obturated with Gutta percha. The removal of Calcium hydroxide and obturation took 30 minutes to complete. All the procedure and assessment were done by the same single dentist.
Intervention code [1] 324317 0
Treatment: Drugs
Comparator / control treatment
Triple antibiotic paste has a broad spectrum antibacterial effect. It was dressed in second group of patients having Oral cutaneous sinus tract. Triple antibiotic paste (TAP) was formed by combining metronidazole, ciprofloxacin, and minocycline in the 1:1:1 concentration. Then 100 mg of each powder was combined in a container to obtain 300 mg of antibiotic powder. This powder was then dissolved in 300 ml of normal saline to yield 1 mg/ml of TAP (with a watery consistency).The paste was packed in the root canal with Gutta percha point by single qualified dentist at Operative department, Rawal hospital, Islamabad. The 1st treatment session was about 60 minutes which included root canal preparation and disinfection with Sodium hypochlorite. Later, the canal was packed with Triple-antibiotic paste for 3 weeks. The frequency was once in 3 weeks. When sinus tract healed, The disinfectant was washed with Sodium hypochlorite irrigation manually. The canal was obturated with Gutta-percha. The removal of disinfectant and obturation took 30 minutes. All the procedure and assessment were done by the same single dentist
Any patients with continued external root resorption after 3 weeks were considered for redressing with calcium hydroxide for a further 3 weeks followed by obturation after healing, at the discretion of the treating dentist.
Control group
Active

Outcomes
Primary outcome [1] 332410 0
The closure of sinus tract was assessed by passing Gutta-percha through wound. Cure of Oral cutaneous sinus tract was assessed by healed wound from physical examination by the same operating dentist.
Timepoint [1] 332410 0
6 weeks from the start of treatment or until cured;
Secondary outcome [1] 413398 0
Cure of external root resorption was assessed by radiographs i.e resorption of root stopped and there was no further decrease in the length of the root or there was continued root formation
Timepoint [1] 413398 0
18 weeks from the start of treatment or until cured;

Eligibility
Key inclusion criteria
Patients having Oral cutaneous sinus tract and restorable involved tooth
Minimum age
16 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with Oral cutaneous sinus tract having non restorable involved tooth

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)
allocation concealment was carried out. The operating dentist did not know until the patient themselves picked up the folded paper randomly, on which the disinfectant name was written, to determine to which group they are allocated and which intracanal disinfectant be used to treat them
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The 2 groups were allocated randomly by lottery method. 5 folded paper had the name of Calcium hydroxide and other 5 folded papers had the name of Triple antibiotic paste. Patients were asked to pick one folded paper. The disinfectant written on that paper was then used for the treatment of that particular patient
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/07/2015
Date of last participant enrolment
Anticipated
Actual
15/07/2021
Date of last data collection
Anticipated
Actual
27/08/2021
Sample size
Target
10
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 24983 0
Pakistan
State/province [1] 24983 0
Islamabad

Funding & Sponsors
Funding source category [1] 312127 0
Self funded/Unfunded
Name [1] 312127 0
Kiran Javed
Country [1] 312127 0
Pakistan
Primary sponsor type
Individual
Name
Kiran Javed
Address
Operative department, Rawal hospital, Lehtrar road, Khanna pul, Islamabad
Country
Pakistan
Secondary sponsor category [1] 313648 0
Hospital
Name [1] 313648 0
Rawal Institute of Health Sciences
Address [1] 313648 0
Operative department, Rawal hospital, Lehtrar road, Khanna pul, Islamabad
Country [1] 313648 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311524 0
Rawal Institute of health sciences
Ethics committee address [1] 311524 0
Operative department, Rawal hospital, Lehtrar road, Khanna pul, Islamabad
Ethics committee country [1] 311524 0
Pakistan
Date submitted for ethics approval [1] 311524 0
22/06/2015
Approval date [1] 311524 0
10/07/2015
Ethics approval number [1] 311524 0

Summary
Brief summary
E- faecalis is found more prevalent in old untreated pulp necrosis. Calcium hydroxide is not effective against E-faecalis. However, triple antibiotic paste is broad spectrum antibiotic effective against majority of bacteria including E-faecalis. The hypothesis of the study was that may be Triple antibiotic paste was more efficient as compared to Calcium hydroxide in treating Oral cutaneous sinus tract and external root resorption. The approval was taken from the ethical committee of Rawal Institute of health sciences. The patients were first presented to Out patient department (OPD) of Rawal Institute of health sciences. Doctors from OPD were well informed of the study. So, they referred those patients immediately to the members of the study group where they had a detailed history and extra and intra oral examination.
Studies have suggested that Calcium hydroxide (CaOH) is not effective against Enterococcus faecalis and Candida albicans. Alternative, Triple antibiotic paste(TAP) consists of a mixture of minocycline, metronidazole and ciprofloxacin which is considered to have an exceptional antimicrobial activity even with E. faecalis and C. albicans.
Extensive literature search showed that no study has been done on oral cutaneous sinus tract(OCST) and external root resorption(ERR), together. Authors of majority of case reports/ case series have used CaOH as a disinfectant for treating OCST. However, no study has been done till now, to identify the best disinfectant for treating OCST and ERR, both.
The objective of the current study was to compare the efficacy of CaOH and TAP for the treatment of OCST and ERR. This helps in identifying the best disinfectant for the management of OCST and ERR.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121402 0
Dr Kiran Javed
Address 121402 0
Operative department, Rawal institute of Health Science, Lehtrar road, Khanna Pul, Islamabad.
Country 121402 0
Pakistan
Phone 121402 0
+923349557439
Fax 121402 0
Email 121402 0
kiran1406@yahoo.com
Contact person for public queries
Name 121403 0
Dr Kiran Javed
Address 121403 0
Operative department, Rawal institute of Health Science, Lehtrar road, Khanna Pul, Islamabad.
Country 121403 0
Pakistan
Phone 121403 0
+923349557439
Fax 121403 0
Email 121403 0
kiran1406@yahoo.com
Contact person for scientific queries
Name 121404 0
Dr Kiran Javed
Address 121404 0
Operative department, Rawal institute of Health Science, Lehtrar road, Khanna Pul, Islamabad.
Country 121404 0
Pakistan
Phone 121404 0
+923349557439
Fax 121404 0
Email 121404 0
kiran1406@yahoo.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
confidential


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17041Informed consent form  kiran1406@yahoo.com 384586-(Uploaded-26-08-2022-07-36-06)-Study-related document.docx
17042Ethical approval  kiran1406@yahoo.com 384586-(Uploaded-26-08-2022-07-44-52)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.