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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.
Primary outcome Postoperative pain measured using numerical rating scale (NRS)
Secondary outcomes 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 boswellia sacra | Experimental | 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 |
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| Patient with necrotic mandibular premolar will be treated with boswellia sacra | Experimental | 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 |
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| Patients with necrotic mandibular premolar will be treated with calcium hydroxide | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boswellia Sacra | Other |
|
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| 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. T3=post-intracanal medicament removal at 3 or 7 days according to the group. |
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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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aya H. Abo Kashwa, Masters | Contact | 01021547230 | aya.abokashwa@dentistry.cu.edu.eg | |
| Radwa S. Emara, PhD | Contact | 01272141312 | radwa.emara@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Alaa A. El.Baz | Professor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Hospital ,Endodontic clinic | Recruiting | Giza | Manial | 4240101 | Egypt |
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| ID | Term |
|---|---|
| D065260 | Frankincense |
| ID | Term |
|---|---|
| D012116 | Resins, Plant |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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Parallel randomized clinical trial
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Outcome assessors (patients, microbiologist and statistician) will not know Which group the participants will be related to?
| 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 |
| D053147 |
| Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |