Using Boswellia Sacra to reduce pain and bacteria after root canal treatment

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

This study is testing whether Boswellia Sacra can help reduce pain and bacteria after root canal treatment in patients with infected teeth.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 25 Years to 45 Years
• Sex: All
• Sponsor: Cairo University (other)
• Drugs / interventions: radiation
• Locations: 1 site (Giza, Manial)
• Trial ID: NCT05820646 on ClinicalTrials.gov

What this trial studies

This research investigates the effects of Boswellia Sacra compared to calcium hydroxide as an intracanal medicament on postoperative pain intensity and bacterial load reduction in patients undergoing root canal treatment for necrotic pulp in mandibular premolars. The primary outcome is measured using a numerical rating scale (NRS) for pain at various time points after treatment, while secondary outcomes involve bacterial load assessment through agar culture techniques. The study aims to provide insights into the efficacy of Boswellia Sacra in improving patient outcomes post-treatment.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 25-45 with diagnosed pulp necrosis in mandibular single-rooted premolars.

Not a fit: Patients with significant systemic disorders, those who have taken analgesics or antibiotics within 24 hours prior to the procedure, and pregnant women may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management and reduced bacterial infection rates in patients undergoing root canal procedures.

How similar studies have performed: While the use of Boswellia Sacra in dental applications is relatively novel, similar studies have shown promising results with alternative natural medicaments in reducing pain and bacterial load.

Eligibility criteria

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.

Where this trial is running

Giza, Manial

• Cairo University Hospital ,Endodontic clinic — Giza, Manial, Egypt (RECRUITING)

Study contacts

• Study coordinator: Aya H. Abo Kashwa, Masters

Conditions: Intervention