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

Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05820646
• Other study ID #: ENDO 3.7.1
• Status: Recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Cairo University
• Contact: Aya H. Abo Kashwa, Masters
• Phone: 01021547230
• Email: aya.abokashwa[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intervention
• Pain
• Pain, Postoperative

Intervention

Other:
• Boswellia Sacra
Boswellia Sacra used as an intracanal medicament for 3 days Boswellia Sacra used as an intracanal medicament for 7 days

Locations

Country	Name	City	State
Egypt	Cairo University Hospital ,Endodontic clinic	Giza	Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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