Comparative Evaluation of Antimicrobial Efficacy, Clinical and Radiographic Success of Calcium Hydroxide, Chlorhexidine, and Modified Triple Antibiotic Paste in Different Combination Forms As Intracanal Medicaments Against Enterococcus Faecalis in Primary Teeth

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-8
SponsorMahy Abdel Raouf Aly Kamar

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Modified triple antibiotic paste (TAP) mixed with chlorehexidine

    Combination product

    M-TAP with CHX 2%

  • Modified Triple Antibiotic Paste mixed with saline

    Combination product

    M-TAP mixed with saline

  • Calcium Hydroxide mixed with chlorohexidine Intracanal medication

    Combination product

    calcium hydroxide powder mixed with CHX 2% solution as intracanal medication

  • calcium hydroxide mixed with saline as intracanal medication

    Combination product

    calcium hydroxide mixed with saline as intracanal medication for necrotic primary molars

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Calcium Hydroxide mixed with saline as control intracanal medicationActive comparator 1 intervention
Group B: different types and combinations of intracanal medications for necrotic primary molarsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
3 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

Secondary outcomes

1

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)

Time frame
3,6 and 12 months

Other outcomes

1

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)

Time frame
6 and 12 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mahy Abdel Raouf Aly Kamar

Lead sponsor

Cairo University

Sponsor institution

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