Intervention
Conditions
Brief summary
This research will study the effect of Boswellia Sacra versus calcium hydroxide as an intracanal medicament on postoperative pain intensity measured using numerical rating scale (NRS) and bacterial load reduction reduction determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml) in mandibular premolars with necrotic pulp.
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 outcomes 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 3 or 7 days according to the group.
Interventions
OTHERBoswellia Sacra
1. Boswellia Sacra used as an intracanal medicament for 3 days 2. Boswellia Sacra used as an intracanal medicament for 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, microbiologist and statistician) will not know Which group the participants will be 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 whom 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 pain scale and can sign the informed consent. 6. Mandibular Single rooted premolars, having single root canal: * Diagnosed clinically with pulp necrosis. * Absence of spontaneous pulpal pain. * Positive pain on percussion denoting apical periodontitis. * Periapical radiolucency not exceeding 2\*2 mm radiographically. * 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 as it might alter their pain perception. 3. Pregnant women: to avoid radiation exposure, anesthesia, medication and hormonal Fluctuation that might increase pain prevalence. 4. Patients reporting bruxism, clenching, TMJ problems or traumatic occlusion: to avoid further pressure on inflamed tooth which induce subsequent irritation and inflammation. 5. Patients with two or more adjacent teeth requiring endodontic treatment. 6. Teeth that requires further procedural steps or multidisciplinary approach, which is out of this experiment's scope: i. Association with swelling or fistulous tract. ii. Acute periapical abscess. iii. Mobility Grade II or III. iv. Pocket depth more than 5mm. v. Previous root canal treatment. vi. Non -restorable vii. Immature roots viii. 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. T3=post-intracanal medicament removal at 3 or 7 days according to the group. | 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 swelling | Up to 48 hours post- operatively | • Incidence of inter-appointment swelling measured using visual analog scale of postoperative swelling (VAS) |
| Incidence of analgesic intake after root canal treatment | Up to 48 hours post- operatively | Incidence of analgesic intake after root canal treatment, using numerical counting. |
Countries
Egypt
Contacts
Primary ContactAya H. Abo Kashwa, Masters
Backup ContactRadwa S. Emara, PhD
Outcome results
None listed