Effect of Boswellia Sacra as an Intracanal Medicament on Postoperative Pain Intensity and Bacterial Load Reduction

Study Overview
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Brief Summary
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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
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Primary outcome Postoperative pain measured using numerical rating scale (NRS) After placement of intracanal medicament at 6, 12, 24 and 48 hours. 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) . Sample 1 (S1): after access preparation and pre-instrumentation. Sample 2 (S2): post-instrumentation. Sample 3 (S3): post-intracanal medicament removal at 3 or 7 days according to the group.

Official Title
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Effect of Boswellia Sacra Versus Calcium Hydroxide as an Intracanal Medicament on Postoperative Pain Intensity and Bacterial Load Reduction in Necrotic Mandibular Premolars: A Randomized Clinical Trial

Conditions
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Intervention

Intervention / Treatment
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* Other: Boswellia Sacra


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 25-45 years old. Males or females. Healthy patients whom are categorized as I or II according to The American Society of Anesthesiologists. (ASA I or II) Patients' accepting to participate in the trial. Patients who can understand pain scale and can sign the informed consent. 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: 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 as it might alter their pain perception. Pregnant women: to avoid radiation exposure, anesthesia, medication and hormonal Fluctuation that might increase pain prevalence. Patients reporting bruxism, clenching, TMJ problems or traumatic occlusion: to avoid further pressure on inflamed tooth which induce subsequent irritation and inflammation. Patients with two or more adjacent teeth requiring endodontic treatment. 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. Inability to perceive the given instructions.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel randomized clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with necrotic mandibular premolars will be treated with boswellia sacra<br>25-45 years old patients with necrotic single rooted mandibular premolar with single canal with periapical lesion will be treated with boswellia sacra as an intracanal medicament for 3 days | Other: Boswellia Sacra<br>* Boswellia Sacra used as an intracanal medicament for 3 days Boswellia Sacra used as an intracanal medicament for 7 days<br>|
| Experimental: Patient with necrotic mandibular premolar will be treated with boswellia sacra<br>25-45 years old patients with necrotic single rooted mandibular premolar with single canal with periapical lesion will be treated with boswellia sacra as an intracanal medicament for 7 days | Other: Boswellia Sacra<br>* Boswellia Sacra used as an intracanal medicament for 3 days Boswellia Sacra used as an intracanal medicament for 7 days<br>|
| Active Comparator: Patients with necrotic mandibular premolar will be treated with calcium hydroxide<br>25-45 years old patients with necrotic single rooted mandibular premolar with single canal with periapical lesion will be treated with calcium hydroxide as an intracanal medicament for 7 days | Other: Boswellia Sacra<br>* Boswellia Sacra used as an intracanal medicament for 3 days Boswellia Sacra used as an intracanal medicament for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. T3=post-intracanal medicament removal at 3 or 7 days according to the group. | 
| Incidence of inter-appointment swelling | • Incidence of inter-appointment swelling measured using visual analog scale of postoperative swelling (VAS) | Up to 48 hours post- operatively | 
| Incidence of analgesic intake after root canal treatment | Incidence of analgesic intake after root canal treatment, using numerical counting. | Up to 48 hours post- operatively |