Anti-bacterial Potential of Nano Calcium Hydroxide as an Intracanal Medication
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age21-49
SponsorBritish University In Egypt
About this trial
The aim of the study is to evaluate the anti-bacterial potential of Nano Calcium Hydroxide as an intracanal medication in primary endodontic treatment of permanent molars.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
healthy males and females.
age range between 21-49.
patients with no physical disability or psychological problems.
patients presenting with single permanent molar with signs and/or symptoms of apical periodontitis, and having Periapican index ≥ 2.
Disqualifiers
pregnant women.
patients with immune-compromised disease.
patients with complicated systemic diseases.
patients who took antibiotics within a period of 1 month.
Trial design
Design model
Parallel
Treatments tested in this trial
Calcium hydroxide
Drugplacement of intracanal medication for the three groups will be done after cleaning and shaping of the root canals and it will be left for one week.
nano calcium hydroxide
Drugplacement of intracanal medication for the three groups will be done after cleaning and shaping of the root canals and it will be left for one week.
Treatment groups
54 Participants
are divided into 3 treatment groupsGroup A: Nano calcium hydroxide in hydrogel formExperimental treatment 1 intervention
Group B: Nano calcium hydroxide in paste formActive comparator 1 intervention
Group C: Conventional calcium hydroxide in paste formActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
bacterial count
variation in bacterial count between 'nano calcium in hydrogel form' group compared with the other groups. The evaluation will be done by quantitative microbiological assessment test. Three microbiological samples will be collected from each patient. Sterile paper points will be used for collecting intracanal content and it will be sealed in Eppendorf tube until the samples reach laboratory center. Tubes will be labelled as following: S1 - S2 - S3 according to the stage of obtaining the sample. S1: will be obtained after access cavity and patency of canals S2: will be obtained by paper point that match the size of master apical file, after complete cleaning and shaping. S3: will be obtained on the seventh day from the intracanal placement appointment. paper points will be used after complete removal of the intracanal medication from the root canals.
Time frame
on the seventh day from intercanal medication placement appointmentSecondary outcomes
1
periapical healing
The participants will be recalled after at least 6 months, and radiographic examination of the treated tooth will be performed. Preoperative and recall radiographs of teeth will be each assigned a PAI score by 2 blinded, independent, and calibrated examiners according to Periapical index score (PAI) : * PAI 1: Normal periapical structure. * PAI 2: Bone structural changes indicating but not pathognomonic for apical periodontitis. * PAI 3: Bone structural changes with some mineral loss characteristic for apical periodontitis. * PAI 4: Well-defined apical radiolucency. * PAI 5: Radiolucency with radiating expansion of bone structural changes.
Time frame
participants will be recalled after 6 months from the obturation for radiographic examination2
incidence and intensity of pain
patients will receive visual analogue scale (VAS) to help them assess pain presence and intensity each day for the following three days after intracanal placement appointment (after 24 hours, 48 hours, and 72 hours)
Time frame
Pain intensity will be assessed each day for three days following initial treatment3
incidence of flare up
Flare up will be presented by 'yes' for developing swelling, and 'no' for not developing swelling. it will be recorded on a chart that will be given to the patients after the initial treatment
Time frame
incidence of flare up will be recorded each day after the intracanal medication placment visit until the next visit (after seven days)Sponsors and contacts
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Source ClinicalTrials.gov