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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05820646
Other study ID # ENDO 3.7.1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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