The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-50
SponsorBritish University In Egypt
About this trial
The goal of this randomized clinical trial is to evaluate the capability of the material to exert bacterial reduction of diclofenac sodium versus of that calcium hydroxide paste when these materials are used as intracanal medications in permanent molar teeth with chronic apical periodontitis.
The main question\[s\] it aims to answer are:
• Will the diclofenac sodium (NSAIDs) possess antimicrobial efficacy to be used effectively as an intracanal medicament similar to that of calcium hydroxide in primary endodontic treatment? Participants will be allocated randomly into three equal groups by using computer generated randomization, according to the type of intracanal medication.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients with teeth diagnosed with apical periodontitis
Periapical Index (PAI) ≥ 2
The teeth are restorable
Disqualifiers
Teeth with immature roots
Non restorable teeth
Medically compromised patients with systemic complication that would alter the treatment.
Teeth with internal/external root resorption
Trial design
Design model
Parallel
Treatments tested in this trial
Diclofenac Sodium
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.
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
48 Participants
are divided into 3 treatment groupsGroup A: High concentration of diclofenac sodiumExperimental treatment 1 intervention
Group B: Low concentration of diclofenac sodiumActive comparator 1 intervention
Group C: Calcium hydroxideActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Bacterial count
Variation in bacterial count in high concentration of Diclofenac Sodium group compared by group of low concentration of Diclofenac Sodium group and calcium hydroxide group.
Time frame
On the seventh day from of intracanal medication placement appointmentSecondary outcomes
1
Periapical healing
Change in the size of periapical lesion (according to Periapical index scale). 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 Periapical index 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 examination.2
incidence and intensity of pain
Patient will receive visual analogue scale (VAS) that will include a 10 cm line in which number 0 will correspond to no pain and number 10 will indicate unacceptable pain. Evaluation of intensity and incidence of pain, will be assessed each day for the following first three days after intracanal placement appointment (after 24 hours, 48 hours and 72 hours).
Time frame
Pain intensity will be assessed at 24 hours, 48 hours and 72 hours following initial treatment using a visual analogue scale3
Incidence of flare-ups
Flare-up will be defined to patients as the development of swelling after treatment and will be represented by "Yes" (flare-up) or "No" (no flare-up). It will be recorded on chart that will given to the patients after the initial treatment.
Time frame
Presence of flare-ups will be recorded each day after the intracanal medication placement visit till the next visit (after seven days).Sponsors and contacts
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Source ClinicalTrials.gov