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Effect of Bio-C Temp Versus Calcium Ydroxide as Intracanal Dressings on Postoperative Pain Intensity and Periapical MMP-9 Level in Patients With Necrotic Pulp

ConditionsIntracanal DressingApical PeriodontitisCalcium HydroxideBiomarkersInflammatory Mediators
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorCairo University

About this trial

To compare the effect of Bio-C Temp Bioceramic intracanal dressing versus calcium hydroxide as intracanal medicaments on:

* Intensity of postoperative pain * levels of MMP -9 in Periapical Fluids.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18-50 years old.

Males and females.

Healthy patients categorized as I or II according to The American Society of Anesthesiologists.

Diagnosed clinically with pulp necrosis.

Disqualifiers

Medically compromised patients having significant systemic disorders (ASA III or IV).

Pregnant females.

If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.

Teeth with multiple canals. 9

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bio-C Temp Intracanal Medication

    Drug

    Bio-C Temp Bioceramic intracanal dressing in the form of injectable premixed paste

  • Calcium Hydroxide Intracanal medication

    Drug

    Calcium Hydroxide intracanal dressing in the form of injectable premixed paste

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Bio-C TempExperimental treatment 1 intervention
Group B: Calcium HydroxideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intensity of post-operative pain

Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)

Time frame
6 hours post-instrumentation
2

Intensity of post-operative pain

Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)

Time frame
12 hours post-instrumentation
3

Intensity of post-operative pain

Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)

Time frame
24 hours post-instrumentation
4

Intensity of post-operative pain

Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)

Time frame
48 hours post-instrumentation

Secondary outcomes

1

Periapical MMP-9 level

Level Of MMP-9 Enzyme in the periapical tissue fluid, quantified by ELISA

Time frame
at the first visit post- instrumentation
2

Periapical MMP-9 Level

Level of MMP-9 enzyme in the periapical tissue fluid, Quantified by ELISA

Time frame
After 1 week at the second visit (pre-obturation)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: