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NCT Number: NCT06207253

The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament

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.

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Key information

Conditions

Endodontic Disease Dental Pulp Diseases Intracanal Medication Jaw Diseases Mouth Diseases Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Pulp Disease, Dental Stomatognathic Diseases Tooth Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

British university in Egypt

Cairo, Egypt

Location status: Recruiting

Location contact

Summer M Elsayed, Bachelor

CONTACT

[email protected]

01000095124

About this study

The aim of the present study 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 evaluation is to be done using quantitative microbiological assessment from samples extracted from root canals before and after intracanal medicament placement in roots of permanent molars, having PAI score ≥ 2.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with teeth diagnosed with apical periodontitis
  • Periapical Index (PAI) ≥ 2
  • The teeth are restorable

Exclusion criteria

  • Teeth with immature roots
  • Non restorable teeth
  • Medically compromised patients with systemic complication that would alter the treatment.
  • Teeth with internal/external root resorption
  • Patient with an allergy to diclofenac sodium

Treatment and study plan

Diclofenac Sodium

Drug

placement 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

Drug

placement 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.

Primary outcomes

  1. Bacterial count

    Time frame: On the seventh day from of intracanal medication placement appointment

    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.

Secondary outcomes

  1. Periapical healing

    Time frame: participants will be recalled after 6 months from the obturation for radiographic examination.

    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.

  2. incidence and intensity of pain

    Time frame: Pain intensity will be assessed at 24 hours, 48 hours and 72 hours following initial treatment using a visual analogue scale

    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).

  3. Incidence of flare-ups

    Time frame: Presence of flare-ups will be recorded each day after the intracanal medication placement visit till the next visit (after seven days).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Summer M Elsayed, Bachelor

CONTACT

[email protected]

01000095124

Sponsors and collaborators

Lead sponsor

British University In Egypt

Other

Registry information

Official study title

The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament During Root Canal Treatment: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2024
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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