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

NCT06196515 | Recruiting Phase 2

• 1 other identifier: 23-041
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endodontic Disease; Pulp Disease, Dental

Keywords

intracanal medication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• periapical healing

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

• incidence and intensity of pain

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

• incidence of flare up

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

Study Arms (3)

Nano calcium hydroxide in hydrogel form

EXPERIMENTAL

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.

Drug: nano calcium hydroxide

Nano calcium hydroxide in paste form

ACTIVE COMPARATOR

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.

Drug: nano calcium hydroxide

Conventional calcium hydroxide in paste form

ACTIVE COMPARATOR

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.

Drug: Calcium hydroxide

Interventions

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.

Conventional calcium hydroxide in paste form

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.

Nano calcium hydroxide in hydrogel form; Nano calcium hydroxide in paste form

Eligibility Criteria

• Age: 21 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

british university in Egypt - dentistry collage

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Calcium Hydroxide

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Officials

• Shehab Eldin M Saber, doctoral

  British University In Egypt

  STUDY DIRECTOR

Central Study Contacts

Nada T mohamed, bachelor

CONTACT

+21003577451; pg.nada92140021@bue.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: official investigator

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: January 9, 2024
• Study Start: August 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)