CClinicalTrials.gg
Status unknownNCT05582421Updated Nov 10, 2022

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.

An Early Phase 1 interventional study of Diclofenac Sodium in Necrotic Pulp and Apical Periodontitis, sponsored by Cairo University. Status unknown. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-10.

Sponsored by Cairo University · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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

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.

02

Conditions studied

  • Necrotic Pulp
  • Apical Periodontitis

Keywords

  • necrosis
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's planned enrollment of 30 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Sham comparator
    calcium hydroxide

    calcium hydroxide will be placed as intracanal medication between visits.

    Drug: Diclofenac Sodium

  • Active comparator
    diclofenac sodium

    diclofenac sodium will be placed as intracanal medication between visits

    Drug: Diclofenac Sodium

Interventions

  • DrugDiclofenac Sodium

    intracanal medication

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6,12.24.48 hours

Secondary outcomes

  1. Bacterial load reduction

    bacterial counting using agar culture technique after root canal preparation (CFU/ml).

    Time frame: 7 days

Other outcomes

  1. Periapical MMP-9 level

    determined post-instrumentation and pre-obturation by ELISA.

    Time frame: 7 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05582421
Lead sponsor
Cairo University
Responsible party
mohammed awadd (assistant lecturer, Cairo University) — Principal investigator
First posted
Oct 17, 2022
Start date
Dec 2022 (estimated)
Primary completion
Oct 2023 (estimated)
Completion
Aug 2024 (estimated)
Last update
Nov 10, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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