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

NCT ID: NCT06196515

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-31

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Endodontic Disease Pulp Disease, Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Nano calcium hydroxide in hydrogel form

nano calcium hydroxide in hydrogel form is placed in the dry root canals after complete cleaning and shaping procedure.The intracanal medication will be distributed to fill the canals up to the orifice level.

Group Type EXPERIMENTAL

nano calcium hydroxide

Intervention Type 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 in paste form

nano calcium hydroxide in paste form is placed in the dry root canals after complete cleaning and shaping procedure. The intracanal medication will be distributed to fill the canals up to the orifice level.

Group Type ACTIVE_COMPARATOR

nano calcium hydroxide

Intervention Type 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.

Conventional calcium hydroxide in paste form

conventional calcium hydroxide in paste form is placed in the dry root canals after complete cleaning and shaping procedure.The intracanal medication will be distributed to fill the canals up to the orifice level.

Group Type ACTIVE_COMPARATOR

Calcium hydroxide

Intervention Type 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.

Interventions

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Calcium hydroxide

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.

Intervention Type DRUG

nano calcium hydroxide

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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British University In Egypt

OTHER

Sponsor Role lead

Responsible Party

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Nada

official investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shehab Eldin M Saber, doctoral

Role: STUDY_DIRECTOR

British University In Egypt

Locations

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british university in Egypt - dentistry collage

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Nada T mohamed, bachelor

Role: CONTACT

+21003577451

Facility Contacts

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Nada T Mohamed, bachelor

Role: primary

+21003577451

Other Identifiers

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23-041

Identifier Type: -

Identifier Source: org_study_id

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