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

Effect of NanoChitosan Impregnated Calcium Hydroxide Paste as an Intracanal Medication on the Intensity of Postoperative Pain and Bacterial Load Reduction in Necrotic Teeth: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intervention
• Intervention / Treatment: Combination product: NanoChitosan impregnated Calcium Hydroxide

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yasmine ElGhannam; Phone Number: +201099978023; Email: y.elghannam@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; NanoChitosan impregnated Calcium Hydroxide used as an intracanal medication fro 7 days
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; NanoChitosan impregnated Calcium Hydroxide used as an intracanal medication fro 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	T0=Baseline immediate after access preparation . T1=Post-instrumentation. T2=post-intracanal medicament removal at 7 days.
Incidence of inter- appointment flare up	recording the incidence of inter-appointment flare up with a binary scale	Up to 48 hours post- operatively
Number of analgesic tablets taken by the patient after endodontic treatment	Number of analgesic tablets intake after root canal treatment, using numerical counting.	Up to 48 hours post- operatively

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: ICM 101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No