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Not yet recruitingNCT06253247Updated Feb 12, 2024

Effect of NanoChitosan Impregnated Calcium Hydroxide as an Intracanal Medication on Postoperative Pain Intensity and Bacterial Load Reduction

An interventional study of NanoChitosan impregnated Calcium Hydroxide in Intervention, sponsored by Cairo University. Not yet recruiting. Open to participants aged 25 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-12.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
All
01

Study summary

This research will study the effect of NanoChitosan impregnated Calcium Hydroxide versus Calcium Hydroxide as an intracanal medication on postoperative pain intensity measured using numerical rating scale (NRS) and bacterial load reduction determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml) in necrotic teeth.

Read the detailed description

Primary outcome: Postoperative pain measured using numerical rating scale (NRS)

  1. After placement of intracanal medicament at 6, 12, 24 and 48 hours.
  2. After root canal obturation at 6, 12, 24 and 48 hours.

Secondary outcome: Bacterial load reduction determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml)

  1. Sample 1 (S1): after access preparation and pre-instrumentation.
  2. Sample 2 (S2): post-instrumentation.
  3. Sample 3 (S3): post-intracanal medicament removal at 7 days.
02

Conditions studied

  • Intervention

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03

In context

Pain, Postoperative

5,089 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.

This study's planned enrollment of 45 is below the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age between 25-45 years old.
  2. Males or females.
  3. Healthy patients who are categorized as I or II according to The American Society of Anesthesiologists. (ASA I or II)
  4. Patients' accepting to participate in the trial.
  5. Patients who can understand the pain scale and can sign the informed consent.
  6. Mandibular Single rooted premolars, having single root canal: Diagnosed clinically with pulp necrosis.
  7. Positive pain on percussion denoting apical periodontitis.(20)
  8. Slight widening in the periodontal membrane space
  9. Normal occlusal contact with opposing teeth

Exclusion criteria

Exclusion Criteria:

  1. Medically compromised patients having significant systemic disorders (ASA III or IV).
  2. If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
  3. Pregnant women
  4. Patients reporting bruxism, clenching, TMJ problems or traumatic occlusion
  5. Patients with two or more adjacent teeth requiring endodontic treatment.
  6. Teeth that require further procedural steps or multidisciplinary approach.

    1. Association with swelling or fistulous tract.
    2. Acute periapical abscess.
    3. Mobility Grade II or III.
    4. Pocket depth more than 5mm.
    5. Previous root canal treatment.
    6. Non-restorable.
    7. Immature root.
    8. Radiographic evidence of external or internal root resorption, vertical root fracture, perforation, calcification.
  7. Inability to perceive the given instructions.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Patients with necrotic mandibular premolars will be treated with NanoChitosan impregnated Ca(OH)2

    25-45 years old patients with necrotic single rooted mandibular premolars with single canal will be treated with NanoChitosan impregnated Calcium Hydroxide as an intracanal medicament for 7 days

    Combination Product: NanoChitosan impregnated Calcium Hydroxide

  • Active comparator
    Patients with necrotic mandibular premolars will be treated with Calcium Hydroxide

    25-45 years old patients with necrotic single rooted mandibular premolars with single canal will be treated with calcium hydroxide as an intracanal medicament for 7 days

    Combination Product: NanoChitosan impregnated Calcium Hydroxide

Interventions

  • Combination productNanoChitosan impregnated Calcium Hydroxide

    NanoChitosan impregnated Calcium Hydroxide used as an intracanal medication fro 7 days

06

What researchers measure

Primary outcomes

  1. Postoperative pain measured using numerical rating scale

    postoperative pain will be recorded after placement of intracanal medicament and after root canal obturation using numerical rating scale ,An 11-point scale from 0-10 representing pain intensity ,"10" being the most intense pain conceivable.

    Time frame: 48 hours

Secondary outcomes

  1. Bacterial load reduction

    Bacterial load reduction determined by bacterial counting using agar culture technique after root canal preparation (Number of colony forming unit per millilitre)

    Time frame: T0=Baseline immediate after access preparation . T1=Post-instrumentation. T2=post-intracanal medicament removal at 7 days.

  2. Incidence of inter- appointment flare up

    recording the incidence of inter-appointment flare up with a binary scale

    Time frame: Up to 48 hours post- operatively

  3. Number of analgesic tablets taken by the patient after endodontic treatment

    Number of analgesic tablets intake after root canal treatment, using numerical counting.

    Time frame: Up to 48 hours post- operatively

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06253247
Lead sponsor
Cairo University
Responsible party
Yasmine Osama ElGhannam (Principal Investigator, Cairo University) — Principal investigator
First posted
Feb 12, 2024
Start date
Apr 2024 (estimated)
Primary completion
Jun 2024 (estimated)
Completion
Jun 2024 (estimated)
Last update
Feb 12, 2024

Study contacts

Yasmine ElGhannam
Contact
y.elghannam@outlook.com
+201099978023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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