Intracanal MedicationEarly Phase 1NCT05666089
Effect of N-acetylcysteine Versus Calcium Hydroxide Used as an Intracanal Medicament on the Intensity of Postoperative Pain, Bacterial Load Reduction and Levels of MMP -9 in Periapical Fluids in Patients With Necrotic Pulp
A Early Phase 1 study testing N-acetyl cysteine and Calcium hydroxide in people with Intracanal Medication and N-acetylcystine, run by Cairo University at 1 site in Egypt.
Trial summary
To compare the effect of N-acetylcysteine versus calcium hydroxide as intra canal medication on: Intensity of postoperative pain. Bacterial load reduction. levels of MMP -9 in Periapical Fluids. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracanal Medication, N-acetylcystine, Calcium Hydroxide
- What is being tested?
- N-acetyl cysteine and Calcium hydroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Mar 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who are free from any physical or mental handicapping condition.
- Males \& Females with
- Mandibular single rooted permanent premolar teeth.
- Absence of spontaneous pain.
- 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 (Appendix I)
Who cannot join
- Medically compromised patients.
- Pregnant women
- Patients undergoing previous endodontic treatment or analgesics and/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 or teeth that could not be adequately isolated with a rubber dam
- Teeth with vital pulp.
- Immature teeth.
- Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
FACULTY OF DENTISTRY-cairo university
Cairo
Safwa Es. Abd Elglil, MSc. (cairo university), 01001259618, safwaessam91@GMAIL.COM
About this study
Official title: Effect of N-acetylcysteine Versus Calcium Hydroxide Used as an Intracanal Medicament on the Intensity of Postoperative Pain, Bacterial Load Reduction and Levels of MMP -9 in Periapical Fluids in Patients With Necrotic Pulp: A Randomized Clinical Trial
To compare the effect of N-acetylcysteine versus calcium hydroxide as intra canal medication on:
- Intensity of postoperative pain.
- Bacterial load reduction.
- levels of MMP -9 in Periapical Fluids.
- Conditions
- Intracanal Medication, N-acetylcystine, Calcium Hydroxide, Mediators
- Being tested
- N-acetyl cysteine, Calcium hydroxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl cysteineDrug
intracanal medication of NAC with concentration 1 gm/ml in the form of a paste
Calcium hydroxideDrug
intracanal medication of calcium hydroxide paste (metapaste)
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine | Experimental | intracanal medication of NAC paste Receives: Drug: N-acetyl cysteine |
| Calcium hydroxide | Active comparator | intracanal medication of Ca(OH)2 paste Receives: Drug: Calcium hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of postoperative pain
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Measured: 6 hours post-instrumentation.
Intensity of postoperative pain
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Measured: 12 hours post-instrumentation
Intensity of postoperative pain
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Measured: 24 hours post-instrumentation
Intensity of postoperative pain
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Measured: 48 hours post-instrumentation
Intensity of postoperative pain
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Measured: 6 hours post-obturation.
Intensity of postoperative pain
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Measured: 12 hours post-obturation
Intensity of postoperative pain
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Measured: 24 hours post-obturation
Intensity of postoperative pain
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Measured: 48 hours post-obturation
Secondary outcomes (5)
Bacterial load reduction
Bacterial counting using agar Culture technique
Measured: Sample 1 (S1): after access preparation and pre-instrumentation.
Bacterial load reduction
Bacterial counting using agar Culture technique
Measured: Sample 2 (S2): at the end of 1st visit post-instrumentation.
Bacterial load reduction
Bacterial counting using agar Culture technique
Measured: Sample 3 (S3): after 2 weeks intracanal medicament placement (pre-obturation)
Periapical MMP-9 level
using ELISA
Measured: at 1st visit post- instrumentation.
Periapical MMP-9 level
using ELISA
Measured: after 2 weeks at 2nd visit (pre-obturation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start1 Feb 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracanal MedicationStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safwa Essam Mohammed Ahmed Abd el-glil, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666089
- Sponsor's protocol ID
- safwaendo91
- Status last verified
- Dec 2022
- First submitted
- 9 Dec 2022
- Last updated
- 27 Dec 2022
- Results posted
- 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 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of N-acetylcysteine Versus Calcium Hydroxide Used as an Intracanal Medicament on the Intensity of Postoperative Pain, Bacterial Load Reduction and Levels of MMP -9 in Periapical Fluids in Patients With Necrotic Pulp: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05666089
- Acronym / sponsor ID
- safwaendo91
- Conditions
- Intracanal Medication, N-acetylcystine, Calcium Hydroxide, Mediators
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 27 Dec 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.
To compare the effect of N-acetylcysteine versus calcium hydroxide as intra canal medication on:
- Intensity of postoperative pain.
- Bacterial load reduction.
- levels of MMP -9 in Periapical Fluids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine | Experimental | Drug: N-acetyl cysteineintracanal medication of NAC paste |
| Calcium hydroxide | Active comparator | Drug: Calcium hydroxideintracanal medication of Ca(OH)2 paste |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients who are free from any physical or mental handicapping condition.
- Males \& Females with
- Patients' acceptance to participate in the trial.
- Patients who can understand pain scale and can sign the informed consent (Appendix I)
Key exclusion criteria (10 listed)
- Medically compromised patients.
- Pregnant women
- Patients undergoing previous endodontic treatment or analgesics and/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 |
|---|---|---|
| N-acetyl cysteineintracanal medication of NAC with concentration 1 gm/ml in the form of a paste | Drug | N-acetylcysteine |
| Calcium hydroxideintracanal medication of calcium hydroxide paste (metapaste) | Drug | Calcium hydroxide |
Primary outcome
Intensity of postoperative pain
Time frame: 6 hours post-instrumentation.
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Intensity of postoperative pain
Time frame: 12 hours post-instrumentation
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Intensity of postoperative pain
Time frame: 24 hours post-instrumentation
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Intensity of postoperative pain
Time frame: 48 hours post-instrumentation
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Intensity of postoperative pain
Time frame: 6 hours post-obturation.
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Intensity of postoperative pain
Time frame: 12 hours post-obturation
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Intensity of postoperative pain
Time frame: 24 hours post-obturation
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Intensity of postoperative pain
Time frame: 48 hours post-obturation
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
5 secondary outcomes
Bacterial load reduction
Time frame: Sample 1 (S1): after access preparation and pre-instrumentation.
Bacterial load reduction
Time frame: Sample 2 (S2): at the end of 1st visit post-instrumentation.
Bacterial load reduction
Time frame: Sample 3 (S3): after 2 weeks intracanal medicament placement (pre-obturation)
Periapical MMP-9 level
Time frame: at 1st visit post- instrumentation.
Periapical MMP-9 level
Time frame: after 2 weeks at 2nd visit (pre-obturation).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing N-acetyl cysteine and Calcium hydroxide in people with Intracanal Medication and N-acetylcystine, run by Cairo University at 1 site in Egypt.
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 7 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 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of postoperative pain (time frame: 6 hours post-instrumentation.). The study lists 8 primary outcomes in all. 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 27 Dec 2022.