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Post Operative Pain and Level of Endotoxins With Calcium Hydroxide and Calcium Hydroxide Mixed With Chlorhexidine in Treating Necrotic Teeth

NCT03009006 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2017-07-21

No results posted yet for this study

Summary

The aim of this prospective in vivo randomized clinical trial to evaluate influence of combination of calcium Hydroxide (CALCIPAST Paste, Poland) and chlorhexidine Gel 2% (Gluco-Chex 2%, Cerkamed, Poland) in comparison to calcium hydroxide paste (CALCIPAST Paste, Poland) as Intracanal Medication on post operative pain (incidence, degree, duration) and reduction of bacterial endotoxins (quantitative) after endodontic treatment in single rooted necrotic teeth.

According to the inclusion criteria the patients enrolled in the study and allocated randomly into three groups either combination of calcium hydroxide paste intracanal medication with 2% chlorhexidine gel. (group A) or calcium hydroxide paste intracanal medication only (group B) or mechanical preparation without intracanal medications (group C) the endodontic treatment is done at two visits.

The samples of endotoxin divided into three groups: after access (S1), after mechanical instrumentations (S2), after removal intracanal medication (S3), all samples taken by a sterile paper points introduced in the root canal for the working length for 60 seconds.

firstly the patient's medical and dental history is taken. the patients assign on informed consent. and then anaesthetized and access cavity performed and root canal preparation is done by Revo-s system then irrigation and intracanal medication placement inside to canal. the patient's record the post operative pain in sheet with NRS after 4, 24, 48 hours and 2 weeks after first visit. the operator will recall the patient to check the records

second visit After 2 weeks from application of ICM, rubber dam will be applied then removal of the temporary dressing, then a sterile paper point (S3) will be introduced into the canals after irrigation and removal of the remnants of the intracanal medicament with the saline solution.

* Removal of the paper sample to determine the endotoxin concentration.
* The canals will be obturated by single cone technique using gutta percha point tapered 0.4% (Gutta percha point, Revo-S MicroMega CO., LTD, France) corresponding to the final apical size of the file and the root canal sealer will be resin sealer (Adseal, META BIOMED CO., LTD, Korea).
* Pain will be assessed by numerical pain rating scale (NRS) after 14 days from the first visit (at the day of the Obturation) before the beginning of Obturation.

Conditions

  • Necrotic Pulp

Interventions

DRUG

Chlorhexidine 2% gel - Calcium Hydroxide Paste - Non-Setting

Calcium Hydroxide Mixed With Chlorhexidin efficacy of calcium hydroxide and 2 % chlorhexidine gel and combination of both on the anaerobic bacteria, It was clear from the study that calcium hydroxide had limited efficacy against facultative anaerobes, but effective against obligate anaerobes while chlorhexidine only and combination group were effective against all species of anaerobic bacteria

DRUG

Calcium Hydroxide Paste - Non-Setting

Calcium Hydroxide The antimicrobial activity of calcium hydroxide Ca(OH)2 is related to the release of hydroxyl ions in an aqueous environment leading to damage in the bacterial cytoplasmic membrane, protein denaturation and DNA damage

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Sherif Elkhodary, Lecturer of Endodontics · Faculty of Oral and dental Medicine - Cairo University

  • Olfat Shaker, Professor · Faculty of Pharmacy - Cairo University.

  • Geraldine M. Ahmed, ass. professor · Faculty of Oral and dental Medicine - Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-03
Primary Completion
2017-10-31
Completion
2018-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03009006 on ClinicalTrials.gov