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

Endodontic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06196515
• Other study ID #: 23-041
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 2024
• Est. completion date: September 2025

Study information

• Verified date: December 2023
• Source: British University In Egypt
• Contact: Nada T mohamed, bachelor
• Phone: +21003577451
• Email: pg.nada92140021[@]bue.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: September 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Endodontic Disease
• Pulp Disease, Dental
• Stomatognathic Diseases

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	british university in Egypt - dentistry collage	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
British University In Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bacterial count	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.	on the seventh day from intercanal medication placement appointment
Secondary	periapical healing	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.	participants will be recalled after 6 months from the obturation for radiographic examination
Secondary	incidence and intensity of pain	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)	Pain intensity will be assessed each day for three days following initial treatment
Secondary	incidence of flare up	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	incidence of flare up will be recorded each day after the intracanal medication placment visit until the next visit (after seven days)