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NCT Number: NCT06196515

Anti-bacterial Potential of Nano Calcium Hydroxide as an Intracanal Medication

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.

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Key information

Conditions

Endodontic Disease Dental Pulp Diseases Pulp Disease, Dental Stomatognathic Diseases Tooth Diseases

Age range

21 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

british university in Egypt - dentistry collage

Cairo, Egypt

Location status: Recruiting

Location contact

Nada T Mohamed, bachelor

CONTACT

[email protected]

+21003577451

About this study

This study is conducted to evaluate the bacterial reduction capability of hydrogel loaded with Nano Calcium Hydroxide and paste form of nano and conventional calcium hydroxide as an intracanal medication. The hydrogel will be synthesized in a new rapid in situ form that can turn from liquid into gel when reaching body temperature. The efficacy of bacterial reduction will be compared with Nano Calcium Hydroxide and conventional Calcium Hydroxide in paste form. The evaluation is to be done by quantitative microbiological assessment of samples which are gained from the root canal before and after intracanal medication 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

  • 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.

Exclusion criteria

  • pregnant women.
  • patients with immune-compromised disease.
  • patients with complicated systemic diseases.
  • patients who took antibiotics within a period of 1 month.
  • patients with known sensitivity to the medicaments or pharmaceuticals used in this study.
  • Non-restorable teeth including root fractures, and/or advanced periodontal involvement.

Treatment and study plan

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.

nano 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 intercanal medication placement appointment

    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.

Secondary outcomes

  1. periapical healing

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

    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.

  2. incidence and intensity of pain

    Time frame: Pain intensity will be assessed each day for three days following initial treatment

    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)

  3. incidence of flare up

    Time frame: incidence of flare up will be recorded each day after the intracanal medication placment visit until the next visit (after seven days)

    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

Study contacts

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

Nada T mohamed, bachelor

CONTACT

[email protected]

+21003577451

Sponsors and collaborators

Lead sponsor

British University In Egypt

Other

Registry information

Official study title

Evaluation of the Antibacterial Potential of Nano Calcium Hydroxide as an Intracanal Medication: A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2024
Registry last updated
Aug 19, 2024

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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