Minimal Instrumentation With Intracanal Heating and Activation of Sodium Hypochlorite for the Management of Teeth With Periapical Lesions

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSaint-Joseph University

About this trial

this study is the first to demonstrate the efficacy of minimally invasive root canal treatment combined with intracanal heating and activation of NaOCl using a prototype needle on the healing of asymptomatic apical periodontitis of necrotic single rooted teeth. 32 teeth will be randomaly assigned into 2 groups :conventional and conservative technique .In the conventional group : each canal will be prepared using Reciproc Blue 25/08, approximetly 27 ml of NaOCl will be used , the canal will be activated using 20.02 taper tip of a sonic decive . This cyclel will be repeated 3 times and the obturation will be done using a single cone technique with AH plus resin-based sealer . In the second group a size 10 k file will be introduced to confirm patency and to record working length after filling the canal with NaOCl. A glide path will be established using the size 10 FlexoFile to the WL, than Proglider 16.02 to the foramen. After the glide path, the canal will be irrigated with 3 ml of 5, 25 % of NaOCL .The prototype needle tip will be placed in the canal to the length that is a little shorter than the length at binding point , in order to heat and activate the irrigant solution for 30 seconds.Step one is repeated 4 more times and a fresh solution of NaOCl is replaced every time. Canals will be dried using sterile paper points size 15 and the obturation will be performed for all teeth using the same technique as group 1 but with a standardized gutta percha point 2% tapered

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy patients without any known allergic reactions or systemic diseases.

Single rooted teeth.

Fully formed roots.

The ability to place #15 hand file to working length (WL).

Disqualifiers

Roots with broken or immature open apices.

Roots presenting resorption.

Patients younger than 18 years old.

Pregnant patients.

Trial design

Design model

Parallel

Treatments tested in this trial

  • a new prototye device that heat and activate sodium hyochlorite (Aseptico)

    Device

    endoactivator : it is a sonic activator device

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: conventional groupActive comparator 1 intervention
Group B: conservative techniqueExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

efficiency of minimal instrument combined with intracanal heating and activation of NaOCl

evaluation of the clinical and radiographic healing of minimally invasive root canal treatment performed with minimal instrumentation combined with intra-canal heating and activation of NaOCl using a prototype needle on necrotic single rooted tooth with apical periodontitis compared to conventional root canal treatment with sonic activation by comparing the change of the area of the lesion

Time frame
3 , 6 and 9 months follow up

Secondary outcomes

1

To evaluate the speed of repair of healing periapical lesions

To evaluate the speed of repair of healing periapical lesions, using the following formulas: Absolute speed of shrinkage (mm2/day) = ((initial detected area-final area))/(duration of treatment) Relative speed of shrinkage (per day)= ((initial detected area-final area) x 100)/(initial detected area x duration of the treatment )

Time frame
3,6 and 9 months follow up

Other outcomes

Sponsors and contacts

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