About this trial
Comparing between different intracanal medications with different combination forms of Modified Triple Antibiotic Paste, Calcium Hydroxide and Chlorehexidine, regarding antimicrobial efficacy through bacterial reduction count of enterococcus Faecalis and regarding clinical and radiographic success in non vital primary teeth necessitating pulpectomy with follow up time 1 year.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Non-Vital pulps.
Negative response to hot or cold pulp tester (ethyl chloride spray ).
Decayed tooth with spontaneous unprovoked long dull aching pain showing signs of necrosis of the pulp
Disqualifiers
Medically compromised and uncooperative children
Tooth indicated for extraction
Mobile teeth (Miller's Grade 2 or more)
teeth with more than two-thirds of root resorption
Trial design
Parallel
Treatments tested in this trial
Modified triple antibiotic paste (TAP) mixed with chlorehexidine
Combination productM-TAP with CHX 2%
Modified Triple Antibiotic Paste mixed with saline
Combination productM-TAP mixed with saline
Calcium Hydroxide mixed with chlorohexidine Intracanal medication
Combination productcalcium hydroxide powder mixed with CHX 2% solution as intracanal medication
calcium hydroxide mixed with saline as intracanal medication
Combination productcalcium hydroxide mixed with saline as intracanal medication for necrotic primary molars
Treatment groups
Trial outcomes
Primary outcomes
Enterococcus faecalis bacterial reduction
Samples from canal using paper point size 20 with pumping action from the widest canal three times one after the access and gaining patency, second one after chemomechanical preparation and the third one after 7 days from intracanal medication insertion in the canal, then the samples will be placed in sterile vials with thioglycolate (transport medium). The vials will be sealed tightly to avoid contamination and labeled. The labeled vials will be kept in a freezer and will be sent to the laboratory within 1 hour of collection, and samples will be assessed for total E. faecalis count.
Secondary outcomes
Clinical success
measuring pain through presence or absence of pain Visual inspection of any changes (Redness or swelling of vestibular area (presence or absence of any change) Tenderness upon percussion ( positive or negative response) Tenderness upon touching of the vestibulum ( positive or negative response)
Other outcomes
Radiographic success
Digital periapical radiographs for assessing the integrity of the pulp and surrounding structures. Periodontal ligament (PDL) widening, loss of lamina dura, internal or external root resorption, and radiolucency of furcation or periapical pathosis) will be considered as a failure with dichotomous response (yes/no)
Locations
Sponsors and contacts
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Mahy Abdel Raouf Aly Kamar
Lead sponsor
Cairo University
Sponsor institution
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