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

NCT03009006 | Unknown

• 1 other identifier: CEBC-CU-2016-10-147
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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 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

Keywords

Calcium hydroxide intracanal medication; Ca(OH)2 intracanal medication; Chlorhexidene gel; CHX gel; Root canal treatment

Outcome Measures

Primary Outcomes (1)

• postoperative pain

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

  4, 24, 48 hrs and 2 weeks after completion of treatment

Secondary Outcomes (1)

• bacterial endotoxins reductions

  After access cavity, after mechanical preparation and after removal of intracanal medication (2 weeks after the first visit)

Study Arms (3)

Calcium Hydroxide Mixed With Chlorhexidin

EXPERIMENTAL

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

Calcium Hydroxide

EXPERIMENTAL

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

Drug: Calcium Hydroxide Paste - Non-Setting

Placebo

PLACEBO COMPARATOR

Mechanical preparation without intracanal medications.

Drug: Chlorhexidine 2% gel - Calcium Hydroxide Paste - Non-Setting; Drug: Calcium Hydroxide Paste - Non-Setting

Interventions

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

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

Also known as: CHX gel, Ca(OH)2 paste

Calcium Hydroxide Mixed With Chlorhexidin; Placebo

Calcium Hydroxide Paste - Non-Setting DRUG

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

Also known as: Ca(OH)2 intracanal medication

Calcium Hydroxide; Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients in Good Health(American Society Of Anaesthesiology Class II or higher).
• Adult patients from both genders older than 18-50 years old suffering from chronic periapical periodontitis with necrotic pulp.
• single rooted teeth (maxillary and mandibular).
• Patients who can understand numerical rating scale (NRS)
• Patients able to sign informed consent

You may not qualify if:

• Patients with Vital tooth.
• Patients having active pain in more than one tooth.
• Patients who had taken analgesics in 12 hours preceding the preparation.
• Any type of teeth with multi roots.
• Pulp hyperemia or any other conditions other than pulp necrosis like pulpitis or previously accessed teeth with temporary fillings and patients suffering from chronic disease (systemic diseases).
• Pregnant or mentally retarded patients.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (37)

• Singh, Ripu Daman, et al.

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MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Sherif Elkhodary, Lecturer of Endodontics

  Faculty of Oral and dental Medicine - Cairo University

  STUDY CHAIR

• Olfat Shaker, Professor

  Faculty of Pharmacy - Cairo University.

  PRINCIPAL INVESTIGATOR

• Geraldine M. Ahmed, ass. professor

  Faculty of Oral and dental Medicine - Cairo University

  STUDY DIRECTOR

Central Study Contacts

Mohammed Saadi Alarbeed, master degree candidate

CONTACT

+201023455553; mohammed-saadi@dentistry.cu.edu.eg

Geraldine M. Ahmed, ass. professor

CONTACT

+201226322227; geraldine.ahmed@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master candidate at endodontic department faculty of oral and dental medicine CU

Study Record Dates

• First Submitted: December 30, 2016
• First Posted: January 4, 2017
• Study Start: January 3, 2017
• Primary Completion: October 1, 2017
• Study Completion: January 1, 2018
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share