Effect of three endodontic irrigation protocols on quality of obturation and outcome of root canal therapy in primary teeth- A randomized clinical trialâ€
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- A.The quality of the filled canals will be assessed
Study Overview
Brief Summary
Themain purpose of our randomized clinical trial is to evaluate the outcome ofpulpectomy with or without smear layer removal because the effect of smearlayer removal on primary teeth has not been well elucidated.The study will beconducted in the age group of 3-9 years old children in the Department ofPediatric and Preventive Dentistry, M. M. College of Dental Sciences andResearch, Mullana. Screening will be conductedin ‘n’ no. of patients for cases who require pulpectomy for deciduous teethwithin the age groups of 3 to 9 years.A total of minimum 40 teeth will be included in the study using thefollowing inclusion & the exclusion criteria after the consent ofparticipation will be obtained from their parents/guardian.Once eligibility will be confirmed the treatment procedure will beexplained to the parent & after explaining the clinical procedures, informedconsent will be obtained from parents showing willingness for their child’sparticipation. Only one operator will perform all the procedures. A total of 40 teeth will be recruited in the study and will berandomly distributed by chit method in 3 trials and 1 control group. Thequality of the filled canals will be assessed . Also the clinical and radiographic follow up will be done.Theresults will be analyzed statistically using appropriate test.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 3.00 Year(s) to 9.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •History of spontaneous pain
- •Continuous bleeding after amputation of coronal pulp tissue
- •Teeth with pulpal involvement indicative of irreversible pulpitis.
Exclusion Criteria
- •Unrestorable tooth
- •Tooth with inter-radicular or periapical radiolucency involving more than half of the shortest root, measured vertically
- •Tooth with internal root resorption
- •Physiological or pathological external root resorption of more than a third of its length (v) Obliteration of the root canal (vi)Inadequate bone support evidenced by nonphysiological tooth mobility when compared with the contralateral tooth (vii)Clinical signs and symptoms of an active spreading infection with systemic involvement that require antibiotic therapy such as tachycardia, facial swelling, cellulitis, limited mouth opening, high temperature, difficulty in swallowing, and regional lymphadenitis (viii)Anatomic anomalies.
Outcomes
Primary Outcomes
A.The quality of the filled canals will be assessed
Time Frame: The quality of the filled canals will be assessed immediately after root canal obturation
Secondary Outcomes
- Clinical evaluation:(The clinical evaluating features will be Pain, Swelling, Fistula, Sensivity to purcussion.)