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

Not Applicable

Not yet recruiting

• Conditions: Intervention
• Interventions: Combination Product: NanoChitosan impregnated Calcium Hydroxide

• Registration Number: NCT06253247
• Lead Sponsor: Cairo University

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.

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 Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-02
• Study First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-02
• Study First Posted: 2024-02-12
• Last Update Posted: 2024-02-12
• Study Start: 2024-04
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Postoperative pain measured using numerical rating scale	48 hours	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of inter- appointment flare up	Up to 48 hours post- operatively	recording the incidence of inter-appointment flare up with a binary scale
Bacterial load reduction	T0=Baseline immediate after access preparation . T1=Post-instrumentation. T2=post-intracanal medicament removal at 7 days.	Bacterial load reduction determined by bacterial counting using agar culture technique after root canal preparation (Number of colony forming unit per millilitre)
Number of analgesic tablets taken by the patient after endodontic treatment	Up to 48 hours post- operatively	Number of analgesic tablets intake after root canal treatment, using numerical counting.