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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.
Primary outcome: Postoperative pain measured using numerical rating scale (NRS)
Secondary outcome: Bacterial load reduction determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NanoChitosan impregnated Calcium Hydroxide | Combination Product | NanoChitosan impregnated Calcium Hydroxide used as an intracanal medication fro 7 days |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
Inability to perceive the given instructions.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yasmine ElGhannam | Contact | +201099978023 | y.elghannam@outlook.com |
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Parallel randomized clinical trial
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Outcome assessors (patients and statistician) will not know which group the participants are related to
| 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 |