Necrotic PulpEarly Phase 1NCT05582421
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 Early Phase 1 study testing Diclofenac Sodium in people with Necrotic Pulp and Apical Periodontitis, run by Cairo University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp, Apical Periodontitis
- What is being tested?
- Diclofenac Sodium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Aug 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
- 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.
Show all 11Show fewer
- 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
Who cannot join
- 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.
Show all 10Show fewer
- Non-restorable teeth
- Teeth with vital pulp.
- Immature teeth.
- Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
About this study
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
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
Read the 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.
- Conditions
- Necrotic Pulp, Apical Periodontitis
- Being tested
- Diclofenac Sodium
- Keywords
- necrosis
- Medical subject headings
- Dental Pulp Necrosis, Periapical Periodontitis, Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac SodiumDrug
intracanal medication
| Study group | Role | What they receive |
|---|---|---|
| calcium hydroxide | Sham comparator | calcium hydroxide will be placed as intracanal medication between visits. Receives: Drug: Diclofenac Sodium |
| diclofenac sodium | Active comparator | diclofenac sodium will be placed as intracanal medication between visits Receives: Drug: Diclofenac Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6,12.24.48 hours
Secondary outcomes (1)
Bacterial load reduction
bacterial counting using agar culture technique after root canal preparation (CFU/ml).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study startDec 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotic PulpStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Trial Design: Randomized Clinical Trial (Parallel Group) Two Arms Allocation Ratio: 1:1 Framework: Superiority
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammed awadd, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582421
- Sponsor's protocol ID
- 1141821228
- Status last verified
- Nov 2022
- First submitted
- 7 Oct 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05582421
- Acronym / sponsor ID
- 1141821228
- Conditions
- Necrotic Pulp, Apical Periodontitis
- Keywords
- necrosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Trial Design: Randomized Clinical Trial (Parallel Group) Two Arms Allocation Ratio: 1:1 Framework: Superiority
| Arm | Type | Receives |
|---|---|---|
| calcium hydroxide | Sham comparator | Drug: Diclofenac Sodiumcalcium hydroxide will be placed as intracanal medication between visits. |
| diclofenac sodium | Active comparator | Drug: Diclofenac Sodiumdiclofenac sodium will be placed as intracanal medication between visits |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- -
- 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:
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diclofenac Sodiumintracanal medication | Drug | calcium hydroxide, diclofenac sodium |
Primary outcome
change in Intensity of postoperative pain
Time frame: 6,12.24.48 hours
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.
1 secondary outcome
Bacterial load reduction
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Necrotic Pulp
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Diclofenac Sodium in people with Necrotic Pulp and Apical Periodontitis, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Intensity of postoperative pain (time frame: 6,12.24.48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.