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

NCT06253247 | Not Yet Recruiting

• 1 other identifier: ICM 101
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Intervention

Outcome Measures

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.

  48 hours

Secondary Outcomes (3)

• Bacterial load reduction

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

• Incidence of inter- appointment flare up

  Up to 48 hours post- operatively

• Number of analgesic tablets taken by the patient after endodontic treatment

  Up to 48 hours post- operatively

Study Arms (2)

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

EXPERIMENTAL

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

Patients with necrotic mandibular premolars will be treated with Calcium Hydroxide

ACTIVE COMPARATOR

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

NanoChitosan impregnated Calcium Hydroxide COMBINATION_PRODUCT

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

Patients with necrotic mandibular premolars will be treated with Calcium Hydroxide; Patients with necrotic mandibular premolars will be treated with NanoChitosan impregnated Ca(OH)2

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Medically compromised patients having significant systemic disorders (ASA III or IV).
• If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
• Pregnant women
• Patients reporting bruxism, clenching, TMJ problems or traumatic occlusion
• Patients with two or more adjacent teeth requiring endodontic treatment.
• Teeth that require further procedural steps or multidisciplinary approach.
• Association with swelling or fistulous tract.
• Acute periapical abscess.
• Mobility Grade II or III.
• Pocket depth more than 5mm.
• Previous root canal treatment.
• Non-restorable.
• Immature root.
• Radiographic evidence of external or internal root resorption, vertical root fracture, perforation, calcification.
• Inability to perceive the given instructions.

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

Yasmine ElGhannam

CONTACT

+201099978023; y.elghannam@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors (patients and statistician) will not know which group the participants are related to
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel randomized clinical trial

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: April 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share