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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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001350718
Acronym
OCST
Enrollment
10
Registered
2022-10-20
Start date
2015-07-15
Completion date
2021-07-15
Last updated
2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 d

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.

Sponsors

Kiran Javed
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
16 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

Patients having Oral cutaneous sinus tract and restorable involved tooth

Exclusion criteria

Patients with Oral cutaneous sinus tract having non restorable involved tooth

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026