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

Not Applicable

Recruiting

• Conditions: Intervention
• Interventions: Other: Boswellia Sacra

• Registration Number: NCT05820646
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-04-07
• Study First Posted: 2023-04-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12
• Study Start: 2024-05
• Primary Completion: 2024-07
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with necrotic mandibular premolars will be treated with boswellia sacra	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
Patients with necrotic mandibular premolar will be treated with calcium hydroxide	Boswellia Sacra	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
Patient with necrotic mandibular premolar will be treated with boswellia sacra	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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)
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)

Trial Locations

Locations (1)

Cairo University Hospital ,Endodontic clinic; 🇪🇬 Giza, Manial, Egypt