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

Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06253247
• Other study ID #: ICM 101
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: Yasmine ElGhannam
• Phone: +201099978023
• Email: y.elghannam[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intervention
• Pain, Postoperative

Intervention

Combination Product:
• NanoChitosan impregnated Calcium Hydroxide
NanoChitosan impregnated Calcium Hydroxide used as an intracanal medication fro 7 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Incidence of inter- appointment flare up	recording the incidence of inter-appointment flare up with a binary scale	Up to 48 hours post- operatively
Secondary	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