Actively Recruiting

Phase 2
Phase 3
Age: 21Years - 49Years
All Genders
Healthy Volunteers
ID06196515

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

Led by British University In Egypt · Updated on 2024-08-19

54

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the antibacterial effects of Nano Calcium Hydroxide when used as an intracanal medication in primary endodontic treatment of permanent molars with apical periodontitis. This clinical trial compares the bacterial reduction capacity of a rapidly forming hydrogel loaded with Nano Calcium Hydroxide against both nano and conventional calcium hydroxide in paste form. The aim is to better understand which form can more effectively reduce bacteria in root canals of affected teeth. Participants will receive one of three treatments after complete cleaning and shaping of the root canals: Nano Calcium Hydroxide in hydrogel form, Nano Calcium Hydroxide in paste form, or conventional Calcium Hydroxide in paste form. The medication is placed into dry root canals and fills the canals up to the orifice level, left in place for one week. This randomized, double-blind trial compares these three approaches to assess their antibacterial potential. During the study, bacterial samples will be collected from the root canals before and seven days after medication placement to measure bacterial count. Participants will be monitored for pain intensity daily for three days after treatment, flare-ups until the next visit, and periapical healing will be evaluated radiographically six months after the root canal filling. The study involves healthy adults aged 21 to 49 with permanent molars showing signs of apical periodontitis, with a total participation timeline extending up to six months for follow-up assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 21Years - 49Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy males and females
  • Age between 21 and 49 years
  • No physical disability or psychological problems
  • Single permanent molar with signs or symptoms of apical periodontitis and Periapical Index score 2 or higher
Not Eligible

You will not qualify if you...

  • Pregnant women
  • Patients with immune-compromised disease
  • Patients with complicated systemic diseases
  • Patients who took antibiotics within the past month
  • Known sensitivity to the study medications
  • Non-restorable teeth including root fractures or advanced periodontal disease

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 week

Participants receive intracanal medication placed in cleaned and shaped root canals, using either nano calcium hydroxide in hydrogel form, nano calcium hydroxide in paste form, or conventional calcium hydroxide paste. The medication is left in place for one week.

1 visit for medication placement and 1 visit after 7 days for follow-up

Follow-up

Duration - 6 months

Participants are monitored for pain intensity daily for 3 days following initial treatment, incidence of flare-up daily until the 7-day visit, and recalled after 6 months for radiographic examination to assess periapical healing.

Daily pain and flare-up assessments for 7 days, plus 1 visit for 6-month radiographic examination

Trial Site Locations

Total: 1 location

1

british university in Egypt - dentistry collage

Cairo, Egypt

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Research Team

N

Nada T mohamed, bachelor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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