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

NCT ID: NCT06253247

Last Updated: 2024-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Outcome assessors (patients and statistician) will not know which group the participants are related to

Study Groups

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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

Group Type EXPERIMENTAL

NanoChitosan impregnated Calcium Hydroxide

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

NanoChitosan impregnated Calcium Hydroxide

Intervention Type COMBINATION_PRODUCT

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

Interventions

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NanoChitosan impregnated Calcium Hydroxide

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Yasmine Osama ElGhannam

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yasmine ElGhannam

Role: CONTACT

+201099978023

Other Identifiers

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ICM 101

Identifier Type: -

Identifier Source: org_study_id

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