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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Intervention
• Intervention / Treatment: Other: Boswellia Sacra

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aya H. Abo Kashwa, Masters; Phone Number: 01021547230; Email: aya.abokashwa@dentistry.cu.edu.eg
• Study Contact Backup: Name: Radwa S. Emara, PhD; Phone Number: 01272141312; Email: radwa.emara@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Manial
    • Giza, Manial, Egypt, 4240101
      • Recruiting
      • Cairo University Hospital ,Endodontic clinic
      • Contact: Aya H. Abo Kashwa, Masters; Phone Number: 01021547230; Email: aya.abokashwa@dentistry.cu.edu.eg
      • Contact: Radwa S. Emara, PhD; Phone Number: 01272141312; Email: radwa.emara@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with necrotic mandibular premolars will be treated with boswellia sacra; 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; Boswellia Sacra used as an intracanal medicament for 3 days; Boswellia Sacra used as an intracanal medicament for 7 days
Experimental: Patient with necrotic mandibular premolar will be treated with boswellia sacra; 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; Boswellia Sacra used as an intracanal medicament for 3 days; Boswellia Sacra used as an intracanal medicament for 7 days
Active Comparator: Patients with necrotic mandibular premolar will be treated with calcium hydroxide; 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; Boswellia Sacra used as an intracanal medicament for 3 days; Boswellia Sacra used as an intracanal medicament for 7 days

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Alaa A. El.Baz, Professor

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Neurologic Manifestations; Pain, Postoperative; Pain
• Other Study ID Numbers: ENDO 3.7.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No