Back to resultsEffect of Diclofenac Sodium Versus Calcium Hydroxide as Intracanal Medication on the Intensity of Postoperative Pain, Bacterial Load Reduction and MMP-9 Levels in Patients With Necrotic Pulp.
Primary Purpose
Necrotic Pulp, Apical Periodontitis
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Diclofenac Sodium
Sponsored by
About this trial
This is an interventional treatment trial for Necrotic Pulp focused on measuring necrosis
Eligibility Criteria
Inclusion Criteria:
-
Inclusion criteria:
- Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
- Age between 18-50 years.
- Males & Females.
Mandibular single rooted permanent premolar teeth:
- Diagnosed clinically with pulp necrosis.
- Absence of spontaneous pain.
- Positive pain on percussion denoting apical periodontitis.
- Slight widening in the periodontal membrane space or with periapical radiolucency not exceeding 2*2 mm radiographically.
- Patients' acceptance to participate in the trial.
- Patients who can understand pain scale and can sign the informed consent
Exclusion Criteria:
- Medically compromised patients
- Pregnant women.
- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
- Patients reporting bruxism or clenching.
- Teeth that show association with acute periapical abscess and swelling.
- Greater than grade I mobility or pocket depth greater than 5mm.
- Non-restorable teeth
- Teeth with vital pulp.
- Immature teeth.
- Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
calcium hydroxide
diclofenac sodium
Arm Description
calcium hydroxide will be placed as intracanal medication between visits.
diclofenac sodium will be placed as intracanal medication between visits
Outcomes
Primary Outcome Measures
change in Intensity of postoperative pain
measured using numerical rating scale (NRS) at 6, 12, 24 and 48- hours post-instrumentation and at 6, 12, 24 and 48 hours post-obturation.
Secondary Outcome Measures
Bacterial load reduction
bacterial counting using agar culture technique after root canal preparation (CFU/ml).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05582421
Brief Title
Effect of Diclofenac Sodium Versus Calcium Hydroxide as Intracanal Medication on the Intensity of Postoperative Pain, Bacterial Load Reduction and MMP-9 Levels in Patients With Necrotic Pulp.
Official Title
Effect of Diclofenac Sodium Versus Calcium Hydroxide as Intracanal Medication on the Intensity of Postoperative Pain, Bacterial Load Reduction and MMP-9 Levels in Patients With Necrotic Pulp: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
August 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
the aim of this study is to compare the effect of using Diclofenac Sodium Versus Calcium Hydroxide as Intracanal medication on intensity of postoperative pain, bacterial load reduction after root canal preparation and periapical matrix metalloproteinase 9 level (MMP-9) post-instrumentation and pre-obturation in teeth with necrotic pulp
Detailed Description
To compare the effect of diclofenac sodium versus calcium hydroxide as intra canal medication on:
- Primary Outcome Intensity of postoperative pain will be measured using numerical rating scale (NRS) at 6, 12, 24 and 48- hours post-instrumentation and at 6, 12, 24 and 48 hours post-obturation.
Secondary Outcome 1 Bacterial load reduction will be determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml).
Secondary Outcome 2 Periapical MMP-9 level will be determined post-instrumentation and pre-obturation by ELISA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotic Pulp, Apical Periodontitis
Keywords
necrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Trial Design: Randomized Clinical Trial (Parallel Group) Two Arms Allocation Ratio: 1:1 Framework: Superiority
Masking
ParticipantInvestigator
Masking Description
In this proposed study, both the participant and assessor will be blinded. This is achieved where the outcome assessor will not be informed of the group in which the participant is enrolled for subjective outcomes. The participants will be blinded to the study hypothesis as to which intervention is expected to be better.
The patients who already do not know their treatment group will assess the level of their post-operative pain.
The laboratory technician at the microbiological department will not know the treatment group of the patients.
The treatment groups will remain anonymous at the end of the study during assessment by the statistician.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
calcium hydroxide
Arm Type
Sham Comparator
Arm Description
calcium hydroxide will be placed as intracanal medication between visits.
Arm Title
diclofenac sodium
Arm Type
Active Comparator
Arm Description
diclofenac sodium will be placed as intracanal medication between visits
Intervention Type
Drug
Intervention Name(s)
Diclofenac Sodium
Intervention Description
intracanal medication
Primary Outcome Measure Information:
Title
change in Intensity of postoperative pain
Description
measured using numerical rating scale (NRS) at 6, 12, 24 and 48- hours post-instrumentation and at 6, 12, 24 and 48 hours post-obturation.
Time Frame
6,12.24.48 hours
Secondary Outcome Measure Information:
Title
Bacterial load reduction
Description
bacterial counting using agar culture technique after root canal preparation (CFU/ml).
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Periapical MMP-9 level
Description
determined post-instrumentation and pre-obturation by ELISA.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
-
Inclusion criteria:
Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
Age between 18-50 years.
Males & Females.
Mandibular single rooted permanent premolar teeth:
Diagnosed clinically with pulp necrosis.
Absence of spontaneous pain.
Positive pain on percussion denoting apical periodontitis.
Slight widening in the periodontal membrane space or with periapical radiolucency not exceeding 2*2 mm radiographically.
Patients' acceptance to participate in the trial.
Patients who can understand pain scale and can sign the informed consent
Exclusion Criteria:
Medically compromised patients
Pregnant women.
If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
Patients reporting bruxism or clenching.
Teeth that show association with acute periapical abscess and swelling.
Greater than grade I mobility or pocket depth greater than 5mm.
Non-restorable teeth
Teeth with vital pulp.
Immature teeth.
Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Diclofenac Sodium Versus Calcium Hydroxide as Intracanal Medication on the Intensity of Postoperative Pain, Bacterial Load Reduction and MMP-9 Levels in Patients With Necrotic Pulp.
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