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

British University In Egypt

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Pulp Disease, Dental; Endodontic Disease

Treatments: Drug: nano calcium hydroxide; Drug: Calcium hydroxide

Study type: Interventional

Funder types: Other

Identifiers

NCT06196515

23-041

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 21 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 3 patient groups

Nano calcium hydroxide in hydrogel form

Experimental group

Description:

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.

Treatment:

Drug: nano calcium hydroxide

Nano calcium hydroxide in paste form

Active Comparator group

Description:

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.

Treatment:

Drug: nano calcium hydroxide

Conventional calcium hydroxide in paste form

Active Comparator group

Description:

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.

Treatment:

Drug: Calcium hydroxide