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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Effect Of Combination of Calcium Hydroxide And Chlorhexidine Gel 2% as Intracanal Medication in Comparison to Calcium Hydroxide Paste as Intracanal Medication on Postoperative Pain And Bacterial Endot

Brief 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 canal

Detailed Summary:

Medical and dental history: diagnostic charts will be collected in a case report from by the investigators and confirmed for eligibility with the assistant supervisor.

Radiographic examination: preoperative radiographs will be taken to examine the tooth structure, caries detection, periapical status.

Clinical examination: intraoral examination include visual examination for caries, restorations, swelling, fistula, mobility, percussion were done.

Diagnostic criteria for necrotic tooth:

  1. The patient marks moderate to severe pain on the numerical rating scale (NRS)a horizontal line of 11 marks and 10 intervals each takes number form 0 - 10 0 reading represents "no pain", 1- 3 readings represent "mild pain", 4- 6 readings represent "moderate pain", 7- 10 readings represent "severe pain".

    (recording baseline degree of pain preoperatively before initiating the endodontic treatment ) All step will done by operator.

    The measurement time will be at 4 hours, 24 hours, and 48 hours and after 14 days. (Day of Obturation)

  2. The patient not responding to electric pulp tester at higher level than the contralateral tooth or the adjacent tooth if the contralateral one is missing.
  3. Preoperative periapical x- ray film is done to detect any periapical changes.

Intervention:

Forty five patients will include were allocated by random or by chance to receive
Sponsor: Cairo University

Current Primary Outcome: postoperative pain [ Time Frame: 4, 24, 48 hrs and 2 weeks after completion of treatment ]

intensity of postoperative pain between visits by numerical Rating Scale (0- 10)


Original Primary Outcome: Same as current

Current Secondary Outcome: bacterial endotoxins reductions [ Time Frame: After access cavity, after mechanical preparation and after removal of intracanal medication (2 weeks after the first visit) ]

bacterial endotoxins reduction will be assessed by ELISA technique.


Original Secondary Outcome: Same as current

Information By: Cairo University

Dates:
Date Received: December 30, 2016
Date Started: January 2017
Date Completion: January 2018
Last Updated: January 3, 2017
Last Verified: January 2017