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

NCT05820646 | Recruiting

• 1 other identifier: ENDO 3.7.1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

• Incidence of inter-appointment swelling

  Up to 48 hours post- operatively

• Incidence of analgesic intake after root canal treatment

  Up to 48 hours post- operatively

Study Arms (3)

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

Other: Boswellia Sacra

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

Other: Boswellia Sacra

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

Other: Boswellia Sacra

Interventions

Boswellia Sacra OTHER

1. Boswellia Sacra used as an intracanal medicament for 3 days 2. Boswellia Sacra used as an intracanal medicament for 7 days

Patient with necrotic mandibular premolar will be treated with boswellia sacra; Patients with necrotic mandibular premolar will be treated with calcium hydroxide; Patients with necrotic mandibular premolars will be treated with boswellia sacra

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Hospital ,Endodontic clinic

Giza, Manial, 4240101, Egypt

RECRUITING

MeSH Terms

Interventions

Frankincense

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Officials

• Alaa A. El.Baz

  Professor

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors (patients, microbiologist and statistician) will not know Which group the participants will be related to?
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Parallel randomized clinical trial

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 19, 2023
• Study Start: May 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)