Intervention
Conditions
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.
Interventions
COMBINATION_PRODUCTNanoChitosan impregnated Calcium Hydroxide
NanoChitosan impregnated Calcium Hydroxide used as an intracanal medication fro 7 days
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Outcome assessors (patients and statistician) will not know which group the participants are related to
Intervention model description
Parallel randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Incidence of inter- appointment flare up | Up to 48 hours post- operatively | recording the incidence of inter-appointment flare up with a binary scale |
| 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. |
Contacts
Primary ContactYasmine ElGhannam
Outcome results
None listed