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

Primary Purpose

Intervention

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Boswellia Sacra
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intervention

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Cairo University Hospital ,Endodontic clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Patients with necrotic mandibular premolars will be treated with boswellia sacra

Patient with necrotic mandibular premolar will be treated with boswellia sacra

Patients with necrotic mandibular premolar will be treated with calcium hydroxide

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
Incidence of inter-appointment swelling
• Incidence of inter-appointment swelling measured using visual analog scale of postoperative swelling (VAS)
Incidence of analgesic intake after root canal treatment
Incidence of analgesic intake after root canal treatment, using numerical counting.

Full Information

First Posted
March 28, 2023
Last Updated
April 7, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05820646
Brief Title
Effect of Boswellia Sacra as an Intracanal Medicament on Postoperative Pain Intensity and Bacterial Load Reduction
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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) After placement of intracanal medicament at 6, 12, 24 and 48 hours. 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) . Sample 1 (S1): after access preparation and pre-instrumentation. Sample 2 (S2): post-instrumentation. Sample 3 (S3): post-intracanal medicament removal at 3 or 7 days according to the group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel randomized clinical trial
Masking
ParticipantOutcomes Assessor
Masking Description
Outcome assessors (patients, microbiologist and statistician) will not know Which group the participants will be related to?
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with necrotic mandibular premolars will be treated with boswellia sacra
Arm Type
Experimental
Arm Description
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
Arm Title
Patient with necrotic mandibular premolar will be treated with boswellia sacra
Arm Type
Experimental
Arm Description
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
Arm Title
Patients with necrotic mandibular premolar will be treated with calcium hydroxide
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Boswellia Sacra
Intervention Description
Boswellia Sacra used as an intracanal medicament for 3 days Boswellia Sacra used as an intracanal medicament for 7 days
Primary Outcome Measure Information:
Title
Postoperative pain measured using numerical rating scale
Description
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.
Time Frame
48 hours.
Secondary Outcome Measure Information:
Title
Bacterial load reduction
Description
Bacterial load reduction determined by bacterial counting using agar culture technique after root canal preparation (Number of colony forming unit per millilitre)
Time Frame
T0=Baseline immediate after access preparation . T1=Post-instrumentation. T3=post-intracanal medicament removal at 3 or 7 days according to the group.
Title
Incidence of inter-appointment swelling
Description
• Incidence of inter-appointment swelling measured using visual analog scale of postoperative swelling (VAS)
Time Frame
Up to 48 hours post- operatively
Title
Incidence of analgesic intake after root canal treatment
Description
Incidence of analgesic intake after root canal treatment, using numerical counting.
Time Frame
Up to 48 hours post- operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aya Helmy Abo Kashwa, Master degree
Phone
01021547230
Email
aya.abokashwa@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Radwa Sameeh Emara, phD
Phone
01272141312
Email
radwa.emara@dentistry.cu.edu.eg
Facility Information:
Facility Name
Cairo University Hospital ,Endodontic clinic
City
Giza
State/Province
Manial
ZIP/Postal Code
4240101
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aya Helmy Abo Kashwa, Master degree
Phone
01021547230
Email
aya.abokashwa@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Radwa Sameeh Emara, phD
Phone
01272141312
Email
radwa.emara@dentistry.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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